tag:theconversation.com,2011:/global/topics/medication-abortion-110105/articlesMedication abortion – The Conversation2023-04-26T12:28:46Ztag:theconversation.com,2011:article/2042632023-04-26T12:28:46Z2023-04-26T12:28:46ZChallenging the FDA’s authority isn’t new – the agency’s history shows what’s at stake when drug regulation is in limbo<figure><img src="https://images.theconversation.com/files/522817/original/file-20230425-28-sxmbmf.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2048%2C1370&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">In addition to evaluating new drug applications, the FDA also inspects drug manufacturing facilities.</span> <span class="attribution"><a class="source" href="https://flic.kr/p/bCZpCD">The U.S. Food and Drug Administration/Flickr</a></span></figcaption></figure><p>Political pressure is nothing new for the U.S. Food and Drug Administration. The agency has <a href="https://theconversation.com/the-fdas-big-gamble-on-the-new-alzheimers-drug-162396">frequently come under fire</a> for its drug approval decisions, but attacks on its decision-making process and science itself have increased <a href="https://www.statnews.com/2020/08/27/trump-has-launched-an-all-out-attack-on-the-fda-will-its-scientific-integrity-survive/">during the COVID-19 pandemic</a>.</p>
<p>Recent challenges to the FDA’s authority have emerged in the context of reproductive rights.</p>
<p>On Nov. 18, 2022, a group of anti-abortion doctors and medical groups <a href="https://adflegal.org/sites/default/files/2022-11/Alliance-for-Hippocratic-Medicine-v-FDA-2022-11-18-Complaint.pdf">filed a lawsuit</a> against the FDA, challenging its approval from more than 20 years ago of <a href="https://theconversation.com/mifepristone-is-under-scrutiny-in-the-courts-but-it-has-been-used-safely-and-effectively-around-the-world-for-decades-204163">mifepristone</a>, a drug taken in combination with another medication, misoprostol, to <a href="https://theconversation.com/how-will-the-supreme-courts-decision-on-mifepristone-affect-abortion-access-4-questions-answered-204172">treat miscarriages</a> and used to induce <a href="https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions">more than 50% of abortions</a> in early-stage pregnancies in the U.S.</p>
<p>It is widely believed that the plaintiffs filed the lawsuit in the Northern District of Texas so District Judge Matthew J. Kacsmaryk, a <a href="https://www.nytimes.com/2023/04/07/us/politics/texas-judge-matthew-kacsmaryk-abortion-pill.html">well-known abortion opponent</a>, could oversee the litigation. While Kacsmaryk did issue a preliminary injunction ruling that the FDA lacked the authority to approve mifepristone, an appeal <a href="https://storage.courtlistener.com/recap/gov.uscourts.ca5.213145/gov.uscourts.ca5.213145.183.2_1.pdf">partially reversed</a> the decision and the Supreme Court <a href="https://www.supremecourt.gov/opinions/22pdf/22a901_3d9g.pdf">stayed Kacsmaryk’s order</a>. The case now sits at the 5th U.S. Circuit Court of Appeals and will likely return to the Supreme Court.</p>
<p>The FDA is the government’s oldest consumer protection agency. The effects of this lawsuit could reach far beyond mifepristone – undermining the agency’s authority could threaten its entire drug approval process and change access to commonly used drugs, ranging from amoxycillin and Ambien to prednisone and Paxlovid.</p>
<p>I am a <a href="https://scholar.google.com/citations?user=Yeg0EUgAAAAJ&hl=en">legal scholar</a> whose research focuses in part on the law and ethics of the FDA’s drug approval process. Examining the FDA’s history reveals the unprecedented nature of the current challenges to the agency’s authority.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Chart titled 'Data for Decisions' depicting sources the FDA considers in its decision-making" src="https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=381&fit=crop&dpr=1 600w, https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=381&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=381&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=479&fit=crop&dpr=1 754w, https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=479&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/522844/original/file-20230425-14-2hs75n.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=479&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Then FDA Commissioner George Larrick used this chart during 1964 Senate testimony to illustrate the range of sources the agency uses in evaluating proposals.</span>
<span class="attribution"><a class="source" href="https://flic.kr/p/dv6CFV">The U.S. Food and Drug Administration/Flickr</a></span>
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<h2>Events shaping FDA’s focus on safety</h2>
<p>In its early years, the FDA focused primarily on balancing the competing goals of consumer safety with access to experimental treatments. The priority was strengthening consumer protection to prevent tragedy from recurring. </p>
<p>For instance, at the turn of the 20th century, Congress passed the <a href="https://ncjolt.org/articles/volume-23/volume-23-issue-4/fdas-accelerated-approval-emergency-use-authorization-and-pre-approval-access-considerations-for-use-in-public-health-emergencies-and-beyond/">Biologics Control Act of 1902</a>, providing the federal government the authority to regulate vaccines. This law was introduced after 13 children died from inadvertently contaminated diphtheria antitoxin, which was made from the blood of a horse infected with tetanus. </p>
<p>A few years later, after investigative journalists publicized the unsanitary conditions and food-handling practices in meatpacking plants, Congress passed the <a href="https://ssrn.com/abstract=3237889">Pure Food and Drug Act of 1906</a>, which prohibited the marketing and sale of misbranded and contaminated foods, drinks and drugs.</p>
<p>Similarly, in 1937, approximately 71 adults and 34 children died from ingesting <a href="https://doi.org/10.7326/0003-4819-122-6-199503150-00009">S.E. Massengill’s antibacterial elixir</a>, which contained a poisonous raspberry flavoring added to sweeten the taste. In response, Congress passed the <a href="https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law">Federal Food, Drug and Cosmetic Act of 1938</a>, requiring manufacturers to show that drugs are safe before they go on the market. This act marked the beginning of modern drug regulations and the birth of the FDA as a regulatory agency. </p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/4wIBCoxuOJ0?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">FDA scientist Frances Oldham Kelsey’s decision to not approve thalidomide for use in the U.S. protected Americans from the birth defects that swept newborns in other countries.</span></figcaption>
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<p>Then, in 1962, Dr. Frances Oldham Kelsey, a pharmacologist, physician and medical officer working at the FDA, <a href="https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law">refused to approve thalidomide</a>, a drug marketed in Europe, Canada, Japan and other countries to alleviate morning sickness in pregnant women but later found to cause severe birth defects. Shocking revelations of children born without limbs or suffering from other debilitating conditions motivated Congress to pass the <a href="https://theconversation.com/could-thalidomide-happen-again-46813">Kefauver-Harris Drug Amendments of 1962</a>, which ushered in a more cautious approach to the drug approval process.</p>
<h2>FDA’s turn toward expanding access</h2>
<p>During the 1970s, questions about the limits of safety versus an individual’s right to access arose when cancer patients who wanted access to an unapproved drug derived from apricots, Laetrile, sued the FDA. The agency had blocked the drug’s shipment and sale because it was not approved for use in the U.S. At that time, the Supreme Court <a href="https://tile.loc.gov/storage-services/service/ll/usrep/usrep442/usrep442544/usrep442544.pdf">upheld the FDA’s protective authority</a>, holding that an unproven therapy is unsafe for all patients, including the terminally ill.</p>
<p>The 1980s, however, marks the FDA’s shift toward increasing access following reports of an emerging disease – AIDS – which primarily affected gay men. In the first nine years of the AIDS epidemic, <a href="https://www.cdc.gov/mmwr/preview/mmwrhtml/00001880.htm">over 100,000 Americans died</a>. AIDS patients and their advocates became <a href="https://dx.doi.org/10.2139/ssrn.2739121">vocal critics of the FDA</a>, arguing that the agency was too paternalistic and restrictive following events like the thalidomide scare.</p>
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<a href="https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="ACT UP protestors lying on the ground with tombstone-shaped signs demanding the FDA allow access to experimental HIV/AIDS drugs" src="https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=412&fit=crop&dpr=1 600w, https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=412&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=412&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=518&fit=crop&dpr=1 754w, https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=518&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/522846/original/file-20230425-3279-zhlvri.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=518&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Protests from HIV/AIDS activists like ACT UP spurred the FDA to develop expedited drug approval tracks to meet urgent public health needs.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/protesters-close-the-federal-drug-administration-building-news-photo/1213566352">Mikki Ansin/Peter Ansin via Getty Images</a></span>
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<p>After massive protests, Dr. Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, proposed a <a href="https://www.washingtonpost.com/outlook/2020/04/29/fight-against-aids-has-shaped-how-potential-covid-19-drugs-will-reach-patients/">parallel track program</a> allowing eligible patients access to unapproved experimental treatments. This, along with other existing FDA mechanisms, helped lay the path for other alternative approval pathways, such as <a href="https://theconversation.com/what-are-emergency-use-authorizations-and-do-they-guarantee-that-a-vaccine-or-drug-is-safe-151178">Emergency Use Authorization</a>, which played a large role in permitting use of vaccines and medications pending full FDA approval during the COVID-19 pandemic.</p>
<h2>Future of the FDA</h2>
<p>Despite the FDA’s shift toward increased access, the <a href="https://www.statnews.com/2018/05/31/right-to-try-ron-johnson/">political right has in recent years argued</a> that the agency remains too bureaucratic and paternalistic and should be deregulated – an argument seemingly contrary to the reasoning underlying Kacsmaryk’s recent order that the FDA did not sufficiently evaluate the safety of mifepristone in its approval.</p>
<p>Mifepristone, which has <a href="https://www.ama-assn.org/delivering-care/public-health/ama-court-don-t-overturn-fda-approval-mifepristone">overwhelming data supporting its safety</a>, could remain available to some people in some states regardless of the outcome of this lawsuit. While the FDA approves drugs for consumer use, it does not regulate the general practice of medicine. Doctors can <a href="https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label">prescribe FDA-approved drugs off-label</a>, meaning they could prescribe a drug with a different dose, in a different way or for a different use than what the FDA has approved it for.</p>
<p>The mifepristone case has broad implications for the FDA’s future and could have devastating effects on health in the U.S. Due in part to FDA involvement, public health interventions have led to a <a href="https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6019a5.htm#">62% increase in life expectancy</a> in the 20th century. These include vaccines and medications for childhood illnesses and infectious diseases such as HIV, increased regulation of tobacco, and <a href="https://theconversation.com/fda-approval-of-over-the-counter-narcan-is-an-important-step-in-the-effort-to-combat-the-us-opioid-crisis-198497">over-the-counter Narcan</a> to combat the opioid crisis, among others.</p>
<p>The FDA needs to be able to use its scientific expertise to make data-driven decisions that balance safety and access, without the ability of a single judge to potentially gut the system. The agency’s history is an important reminder of the need for strong administrative agencies and ongoing vigilance to protect everyone’s health.</p><img src="https://counter.theconversation.com/content/204263/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Christine Coughlin is affiliated with the Foundation for Prosecutorial Accountability.</span></em></p>As the government’s oldest consumer protection agency, the FDA has long butted up against drugmakers, activists and politicians. But undermining its work could be harmful to patient health and safety.Christine Coughlin, Professor of Law, Wake Forest UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2041632023-04-26T12:28:33Z2023-04-26T12:28:33ZMifepristone is under scrutiny in the courts, but it has been used safely and effectively around the world for decades<figure><img src="https://images.theconversation.com/files/522668/original/file-20230424-26-v5rdtr.jpg?ixlib=rb-1.1.0&rect=0%2C170%2C2915%2C1755&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Mifepristone is used together with another pill, misoprostol, in medication abortions.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/AbortionPill/513c7c2f6d0346b9b9ddaa2c7344be46/photo?Query=mifepristone%20supreme%20court&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=39&currentItemNo=32">AP Photo/Allen G. Breed</a></span></figcaption></figure><p><em>A <a href="https://theconversation.com/the-supreme-court-rules-mifepristone-can-remain-available-heres-how-2-conflicting-federal-court-decisions-led-to-this-point-203623">flurry of court rulings</a> in April 2023 has left the <a href="https://www.reuters.com/world/us/us-abortion-providers-relieved-wary-supreme-court-preserves-pill-access-2023-04-22/">future of the abortion pill mifepristone in question</a>. For now, a U.S. Supreme Court decision on April 21 <a href="https://theconversation.com/how-will-the-supreme-courts-decision-on-mifepristone-affect-abortion-access-4-questions-answered-204172">allows the drug to remain accessible</a> <a href="https://www.nbcnews.com/health/womens-health/abortion-pill-lawsuit-mifepristone-questions-future-access-rcna79455">without additional restrictions</a> as the merits of the case are <a href="https://www.washingtonpost.com/politics/2023/04/21/mifepristone-abortion-pill-access-supreme-court/">weighed in lower court proceedings</a>.</em> </p>
<p><em>Depending on the outcome, the pill <a href="https://www.reuters.com/legal/government/us-supreme-court-preserves-access-abortion-pill-now-whats-next-2023-04-22/">could face a ban or tightened restrictions</a> on its usage, a possibility that has many health care providers concerned.</em></p>
<p><em>The Conversation asked Grace Shih, a family physician practicing in Washington state, to explain the science behind mifepristone as well as its safety and efficacy in medication abortions.</em></p>
<h2>What is mifepristone, and how does it work?</h2>
<p>Mifepristone is a pill that is <a href="https://theconversation.com/what-is-a-medication-or-medical-abortion-5-questions-answered-by-3-doctors-182646">used in medication abortion</a> during early pregnancy. It was initially <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation">approved by the Food and Drug Administration in 2000</a> and is approved by the FDA for medication abortion up to 10 weeks after the first day of the last menstrual period. </p>
<p>It can be taken as one part of a two-part pill regimen for medication abortion. Mifepristone is prescribed as a 200-milligram dose taken orally, followed by an 800-microgram dose of misoprostol, which is placed in the vagina or between the teeth and cheek, where it dissolves and is absorbed, usually 24 to 48 hours later. </p>
<p>Mifepristone acts by blocking the hormone progesterone, which is necessary for a pregnancy to develop. This stops the pregnancy growth and softens and dilates the cervix. It also prepares the uterus for contractions, increasing its sensitivity to medications such as misoprostol. </p>
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<figcaption><span class="caption">Mifepristone blocks the action of progesterone, a hormone that is needed for a pregnancy to develop.</span></figcaption>
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<p>Misoprostol is a synthetic <a href="https://www.yourhormones.info/hormones/prostaglandins/">prostaglandin</a>. Prostaglandin is a hormonelike substance that has multiple effects, including the stimulation of uterine contractions, which helps expel pregnancy tissue such as the thickened uterine lining and the tissues that are the precursor to the placenta. </p>
<p>Misoprostol is <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf">currently FDA-approved</a> for reducing the risk of gastric ulcers in patients who are at high risk of complications from ulcers. But it is commonly used off-label for things like cervical ripening, or softening, to induce or help with labor. Mifepristone and misoprostol are also both used in the <a href="https://doi.org/10.1056/NEJMoa1715726">medical management of miscarriage</a>.</p>
<p>Medication abortion can also be done with misoprostol alone, an approach known as the misoprostol-only regimen. This <a href="https://doi.org/10.1097/aog.0000000000003017">regimen is safe</a> and has been <a href="https://www.washingtonpost.com/world/2023/04/19/abortion-pill-mifepristone-global-approved/">used widely by people around the world</a>. In the misoprostol-only regimen, an 800-microgram dose is placed in the vagina or between the teeth and cheek every three hours for up to three doses. </p>
<p>Both protocols are very effective, with the two-drug regimen <a href="https://doi.org/10.1097/AOG.0000000000000910">up to 99.6% effective</a> and the <a href="https://doi.org/10.1097%2FAOG.0000000000003017">misoprostol-alone regimen between 84% to 96%</a> in medication abortions.</p>
<h2>Why would a person opt for one regimen or the other?</h2>
<p>People usually don’t choose the type of medication abortion they receive. Because the availability of mifepristone and misoprostol is highly variable, whichever method is available to you is medically safe. Patients should feel assured that guidelines for medication abortion support the <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">safety and efficacy of both medication regimens</a>.</p>
<p>The <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">American College of Obstetricians and Gynecologists</a>, the <a href="https://doi.org/10.1016/j.contraception.2020.08.004">Society for Family Planning</a> and the <a href="https://www.who.int/publications/i/item/9789240039483">World Health Organization</a> all support both types of medication abortion. </p>
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<figcaption><span class="caption">Mifepristone and misoprostol work in tandem to terminate a pregnancy.</span></figcaption>
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<h2>How widely accessible is mifepristone?</h2>
<p>In January 2023, the <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#">FDA updated its guidelines</a> to allow mifepristone to be dispensed through pharmacies with a prescription.</p>
<p>The change means that the drug is available both by mail or at brick-and-mortar pharmacies, as long as that retail pharmacy has been certified. In other words, people who live in states where abortion is not banned can take their mifepristone prescription and get it the way they pick up other medications. </p>
<p>For someone able to pick up mifepristone from a local pharmacy, the process is no different from picking up birth control pills or blood pressure medications. This allows mifepristone and its applications for abortion care and miscarriage management to be treated as typical health care. </p>
<p>While the January 2023 FDA ruling theoretically increases the ways that a person can get mifepristone, so far it has not been widely available at retail pharmacies.</p>
<h2>Can I still get mifepristone?</h2>
<p>The short answer is yes, mifepristone is still FDA-approved. The Supreme Court’s April 21, 2023, ruling means that there will be <a href="https://theconversation.com/how-will-the-supreme-courts-decision-on-mifepristone-affect-abortion-access-4-questions-answered-204172">no changes to mifepristone access for now</a>. However, for use in abortion care, mifepristone still faces restrictions depending on your state’s legislation.</p>
<p>As of April 2023, 27 states have <a href="https://www.guttmacher.org/state-policy/explore/medication-abortion">some restriction on medication abortion</a> according to the <a href="https://www.guttmacher.org/">Guttmacher Institute</a>, a reproductive health policy organization. This includes 12 states that have a near-total ban on abortion and one state that has stopped offering abortion care because of legal uncertainty. </p>
<p>Of the 15 states with restrictions specific to medication abortion, all of them require that medication be provided by a physician and not an advanced practitioner like a nurse practitioner. Six of the states require an in-person visit with a physician, one state requires that mifepristone be taken in the presence of a physician, and one state bans mailing medication abortion pills.</p>
<h2>Evidence-based health care</h2>
<p>As a practicing family physician, I follow the science and make medical decisions with my patients using the most up-to-date evidence. Medication abortion using mifepristone and misoprostol is <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">exceptionally safe and highly effective</a>, as is <a href="https://doi.org/10.1097%2FAOG.0000000000003017">medication abortion using misoprostol alone</a>. Side effects of the misoprostol-only regimen are similar to the combined regimen, though they may last longer because of the need for multiple doses of misoprostol.</p>
<p>Some news coverage has focused on comparing the efficacy of the two regimens. But percentage points mean very little to an individual’s health – what matters is that people get the care they need.</p>
<p>I will continue working, providing and advancing care that is based on science. Leading health professional organizations including the <a href="https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications">American College of Obstetricians and Gynecologists</a>, the <a href="https://policysearch.ama-assn.org/policyfinder/detail/mifepristone?uri=%2FAMADoc%2FHOD.xml-H-100.948.xml">American Medical Association</a> and the <a href="https://www.aafp.org/dam/AAFP/documents/events/nc/congress/nc18-ncfmr-actions-referrals.pdf">American Academy of Family Physicians</a> have all issued statements that call for removing all restrictions around mifepristone and/or support the safety of misoprostol-only medication abortion.</p>
<p><em>This is an updated version of an <a href="https://theconversation.com/what-the-fdas-rule-changes-allowing-the-abortion-pill-mifepristone-to-be-dispensed-by-pharmacies-mean-in-practice-5-questions-answered-197339">article originally published</a> on Jan. 11, 2023.</em></p><img src="https://counter.theconversation.com/content/204163/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Grace Shih does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Mifepristone’s safety in medication abortions has been well established over more than two decades, but legal wrangling leaves the future of the drug hanging in the balance.Grace Shih, Associate Professor of Family Medicine, School of Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2041722023-04-24T12:26:56Z2023-04-24T12:26:56ZHow will the Supreme Court’s decision on mifepristone affect abortion access? 4 questions answered<figure><img src="https://images.theconversation.com/files/522387/original/file-20230421-26-8fh4pq.jpg?ixlib=rb-1.1.0&rect=44%2C29%2C5000%2C3263&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The legal battle over mifepristone could have far-reaching effects on reproductive health care.
</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/AbortionPill/90b940844e254f1d9369d4e5430eca71/photo?Query=mifepristone&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=125&currentItemNo=2">AP Photo/J. Scott Applewhite</a></span></figcaption></figure><p><em>On April 21, 2023, the U.S. Supreme Court ruled that the abortion pill mifepristone, which is used in more than half of all abortions in the U.S., could <a href="https://www.nytimes.com/live/2023/04/21/us/abortion-pill-supreme-court">remain accessible without restrictions</a> – at least for now. The decision is temporary, however, buying time as an appeals court weighs the challenge to mifepristone brought by a Texas judge in early April 2023.</em></p>
<p><em>That ruling <a href="https://theconversation.com/anti-mifepristone-court-decisions-rely-on-medical-misinformation-about-abortion-and-questionable-legal-reasoning-203742">blocked the use of the drug in medication abortions</a> and sought to remove it from the market altogether, questioning its safety. Days later, a U.S. appeals court <a href="https://www.npr.org/2023/04/13/1169217172/abortion-pill-mifepristone-ruling-texas-judge">reversed the suspension on mifepristone</a> but placed tighter restrictions on it, including preventing it from being sent through the mail.</em> </p>
<p><em>The Conversation asked twin sisters <a href="https://scholar.google.com/citations?user=bNJTbmMAAAAJ&hl=en">Jamie Rowen</a>, a legal scholar, and obstetrician and gynecologist <a href="https://www.ucsfhealth.org/providers/dr-tami-rowen">Tami Rowen</a> to put into perspective what the Supreme Court’s decision means for access to the drug moving forward and how it came under legal scrutiny to begin with.</em> </p>
<h2>1. What led up to the Supreme Court’s ruling on mifepristone?</h2>
<p>In September 2022, several groups of anti-abortion doctors <a href="https://adflegal.org/sites/default/files/2022-11/Alliance-for-Hippocratic-Medicine-v-FDA-2022-11-18-Complaint.pdf">sued the Food and Drug Administration</a>, arguing that they were harmed because the FDA’s 2000 approval of mifepristone was flawed and that it did not adequately test the drug for safety, among other claims. The plaintiffs also claimed harm from the FDA’s 2016 and 2021 changes that lifted several restrictions on how the drug could be used or administered. </p>
<p>The doctors brought the case in Texas, where a federal district judge ordered that, while the case was pending, mifepristone should be off the market. </p>
<p>The FDA appealed to the 5th Circuit, asking it for an emergency “stay,” or a hold on, the district court’s order. The 5th Circuit ordered that, while the case is being decided, mifepristone can be on the market but only with its original restrictions from 2000. Under this order, mifepristone could only be used up to seven weeks of pregnancy and required an in-person visit and prescription from a doctor. </p>
<p>The FDA, along with mifepristone’s manufacturer Danco Laboratories, immediately asked the Supreme Court to stay the 5th Circuit’s order. Supreme Court <a href="https://www.supremecourt.gov/publicinfo/reportersguide.pdf">stays are granted</a> when at least five justices agree that the applicants – in this case the FDA and Danco – are likely to succeed, among other considerations.</p>
<p>The majority did not explain its decision in favor of the FDA and Danco. The <a href="https://www.nytimes.com/interactive/2023/04/21/us/23-supreme-court-order.html">two dissents</a> – from Samuel Alito and Clarence Thomas – provide little insight into how the different justices might rule on the case if they decide to review the 5th Circuit’s forthcoming opinion. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/qCwUuphh_A0?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The Supreme Court ruling provided at least temporary relief to many providers who view mifepristone as the gold standard for abortion care.</span></figcaption>
</figure>
<h2>2. What comes next in the courts?</h2>
<p>The Supreme Court’s decision means that mifepristone will remain available until there is a final decision in this case. For now, the case returns to the 5th Circuit. Depending on the outcome of that case, either the plaintiffs or the defendants may ask the Supreme Court to hear the case. If the Supreme Court decides to hear the case, then the final decision on whether mifepristone should be taken off the market or have stricter requirements for use will come from the Supreme Court. If not, the final decision will come from the 5th Circuit. </p>
<p>Although the 5th Circuit is <a href="https://www.ca5.uscourts.gov/oral-argument-information/court-calendars/Details/1661/">scheduled to hear the case on May 17, 2023</a>, there is no fixed time by which it must make its decision. In short, it will likely take at least a year for the case to be decided. Regardless of these lower court decisions, the fact that at least five justices chose to stay the 5th Circuit’s emergency order suggests that the Supreme Court will want to make the final determination in this case.</p>
<h2>3. What does this mean for abortion access moving forward?</h2>
<p>The Supreme Court’s decision to preserve full access to mifepristone until the case concludes leaves the FDA’s current rules in place. These rules allow mifepristone to be administered up to 10 weeks of pregnancy without an in-person visit to a clinic or hospital, through the mail and by a certified pharmacy as an alternative to a doctor’s prescription. </p>
<p>Given the legal uncertainty and the amount of time it takes for a case like this to conclude, the Supreme Court’s April 21, 2023, decision enables ongoing access to mifepristone for the foreseeable future. Roughly 90,000 medication abortions are <a href="https://www.guttmacher.org/fact-sheet/unintended-pregnancy-and-abortion-northern-america">performed annually in the U.S.</a>, the vast majority of which rely on mifepristone as part of a two-medication regimen that also includes the drug misoprostol. </p>
<p>Mifepristone <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation">blocks the hormone progesterone</a>, which is needed for a pregnancy to continue. Misoprostol, which is approved for use in the <a href="http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19268slr037.pdf">treatment of gastric ulcers</a>, also causes uterine contractions and <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">ends the pregnancy</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Extended hand holding two bottles of abortion pills, one mifepristone and the other misoprostol." src="https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/522388/original/file-20230421-26-vksyzg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Mifepristone is used in concert with misoprostol in the two-pill regimen. Misoprostol can also be used by itself in a one-pill medication abortion.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/MedicationAbortionPillsExplainer/53c242048271405bb7851a498ce5ad5c/photo?Query=mifepristone&mediaType=photo&sortBy=&dateRange=Anytime&totalCount=125&currentItemNo=32">AP Photo/Charlie Neibergall</a></span>
</figcaption>
</figure>
<p>If the ultimate decision is in favor of the plaintiff doctors, the effects on pregnant people could be felt immediately. Taking mifepristone off the market until the FDA makes safety findings that are sufficient to the court, or restricting access to it through additional requirements, would lead people seeking medication abortions to use a misoprostol-only regimen or to seek surgical abortions. Though safe and effective, the misoprostol-only alternative would lead to <a href="https://doi.org/10.1016/j.contraception.2010.09.002">higher rates of incomplete abortions</a> that require additional, usually surgical, intervention. These procedures would exacerbate harms to those electing or experiencing abortion, <a href="https://doi.org/10.1111/aogs.13788">including risks to subsequent pregnancies</a>. </p>
<p>Likewise, forcing people to delay their abortions imposes numerous health risks. Even Supreme Court justices ambivalent about legal rights to abortion have <a href="https://www.reuters.com/article/us-usa-court-abortion-idUKKCN0W40BZ">expressed a desire</a> for abortions to occur as early as possible. </p>
<p>Limiting access to mifepristone could have additional harmful effects. Mifepristone also helps women complete a miscarriage at a <a href="https://doi.org/10.1016/S0140-6736(20)31788-8">much higher success rate</a> than the standard medical regimens that do not use mifepristone, sparing the risk of a surgical procedure and complications if the pregnancy remains in the uterus. </p>
<p>For now, the Supreme Court has created a buffer to help reduce such obstacles and adverse events while the lower courts, and likely the Supreme Court itself, decide the case.</p>
<h2>4. What are the implications for other medications?</h2>
<p>The Supreme Court did not explain whether it thinks the plaintiffs will be successful in their argument that the FDA should not have approved mifepristone in 2000 or changed the rules around its use in subsequent years.</p>
<p>When questioning an administrative agency, such as the FDA, a court asks whether the regulation was “arbitrary and capricious.” The 5th Circuit agreed with the district court that the 2016 regulation change was arbitrary and capricious because there was no study showing the effects of removing multiple restrictions on the medication at once. The FDA did review multiple studies that <a href="https://www.supremecourt.gov/DocketPDF/22/22A901/263483/20230414093601611_SCOTUS%20Stay%20Application%204-14-23%20Final.pdf">showed lifting these individual restrictions</a> was indeed <a href="https://doi.org/10.1097/aog.0000000000004082">safe for those taking mifepristone</a>. </p>
<p>Second-guessing the agency’s scientific determination in this way challenges the nuts and bolts of the FDA’s process and certainty in the drug manufacturing market.
This is particularly true for medicine that may have higher risks but can be lifesaving for patients. Undermining the FDA’s authority could also carry over to controversial medications like the COVID-19 vaccine or even the <a href="https://www.cancer.gov/news-events/cancer-currents-blog/2021/hpv-vaccine-parents-safety-concerns">vaccine against human papillomavirus, or HPV</a>, the most <a href="https://www.womenshealth.gov/a-z-topics/human-papillomavirus#">common sexually transmitted infection</a> in the U.S. Given parental concerns about vaccine safety and the belief that making sex medically safer for young people encourages them to have sex, the HPV vaccine <a href="https://journalofethics.ama-assn.org/article/hpv-vaccine-controversy/2012-01">has faced heightened scrutiny</a> from vaccine opponents about its safety record. </p>
<p>Leaders from across the <a href="https://www.nytimes.com/2023/04/20/opinion/abortion-pill-case-supreme-court.html">scientific, pharmacologic and business world</a> have sounded the alarm at the implications of these decisions on approved drugs and those in development. </p>
<p>Finally, the legal wrangling over mifepristone will no doubt affect ongoing research into the many potential uses of this medication beyond abortion. These legal challenges <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1173426/">delayed the introduction of mifepristone</a> to the U.S. market decades ago, <a href="https://www.ncbi.nlm.nih.gov/books/NBK234199/">and they continue to impair</a> studies on mifepristone’s potential to help prevent certain cancers, uterine infections and other illnesses affected by progesterone. </p>
<p>For now, the Supreme Court has put off a decision that could profoundly change the regulation of medicines in the U.S.</p><img src="https://counter.theconversation.com/content/204172/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jamie Rowen receives funding from National Science Foundation and Humanity United.</span></em></p><p class="fine-print"><em><span>Tami S. Rowen does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The Supreme Court’s ruling on mifepristone keeps the drug accessible for now, but its future is still in limbo.Jamie Rowen, Associate Professor of Legal Studies and Political Science, UMass AmherstTami S. Rowen, Associate Professor of Obstetrics, Gynecology and Gynecologic Surgery, University of California, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1989782023-02-09T13:35:35Z2023-02-09T13:35:35ZMedication abortion could get harder to obtain – or easier: There’s a new wave of post-Dobbs lawsuits on abortion pills<figure><img src="https://images.theconversation.com/files/508726/original/file-20230207-28-4ztdo9.jpg?ixlib=rb-1.1.0&rect=287%2C23%2C3706%2C2502&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Legal battles are being waged over mifepristone, one of two drugs used in medication abortion.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/mifepristone-and-misoprostol-the-two-drugs-used-in-a-news-photo/1241524154?adppopup=true">Robyn Beck/AFP via Getty Images</a></span></figcaption></figure><p>Medication abortion now accounts for <a href="https://www.cdc.gov/reproductivehealth/data_stats/abortion.htm">more than half of all abortions</a> in the United States.</p>
<p>Typically, patients take a <a href="https://theconversation.com/what-is-a-medication-or-medical-abortion-5-questions-answered-by-3-doctors-182646">two different pills</a>: first mifepristone, then misoprostol. </p>
<p>Even though this option has been legally available for more than two decades, two recent events have raised legal questions about it. First, the Supreme Court’s <a href="https://www.oyez.org/cases/2021/19-1392">Dobbs v. Jackson Women’s Health</a> ruling overturned the constitutional right to abortion recognized in 1973 in <a href="https://www.oyez.org/cases/1971/70-18">Roe v. Wade</a>. Second, in January 2023, the Food and Drug Administration decided that <a href="https://theconversation.com/what-the-fdas-rule-changes-allowing-the-abortion-pill-mifepristone-to-be-dispensed-by-pharmacies-mean-in-practice-5-questions-answered-197339">certified U.S. pharmacies could sell mifepristone</a> <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation">by prescription</a>.</p>
<p>The result is a raft of new legal battles over access to medication abortion.</p>
<p>Some <a href="https://www.smith.senate.gov/u-s-senator-tina-smith-and-rep-cori-bush-re-introduce-legislation-to-protect-access-to-medication-abortion/">congressional lawmakers seek</a> to protect the right to access the pills through pharmacies and telehealth in states where abortion remains legal. At least <a href="https://www.nytimes.com/2023/01/25/health/abortion-pills-ban-genbiopro.html">three lawsuits are pending</a>, and some states that have banned abortion altogether or have restricted access to it are vowing to block the new federal rules. South Dakota Governor Kristi Noem, for example, has <a href="https://apnews.com/article/abortion-health-sd-state-wire-south-dakota-medication-21146e96236c67244331a8cfe64e84d3">threatened to prosecute any pharmacist</a> who sells the pills in her state.</p>
<p><a href="https://www.law.virginia.edu/faculty/profile/nrc8g/2915359">As experts</a> on <a href="https://www.law.gwu.edu/sonia-m-suter">reproductive health and justice</a>, we’re trying to untangle when and where mifepristone might be available and what these contradictory trends signal.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/kzd4ABInBio?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Mifepristone and misoprostol work in tandem to terminate a pregnancy.</span></figcaption>
</figure>
<h2>Prescribing abortion drugs</h2>
<p>Who has the authority to determine when, how or whether abortion medication can be prescribed and sold?</p>
<p>Under its long-held, congressionally granted authority to regulate pharmaceutical products, <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation">the FDA approved mifepristone in 2000</a> after an extensive review demonstrated that the drug was safe and effective for early pregnancy termination.</p>
<p>From the beginning, the sale of mifepristone was tied to several safety requirements known as a risk evaluation and mitigation strategy. Initially, the drug had to be dispensed by <a href="https://www.acog.org/news/news-articles/2022/03/understanding-the-practical-implications-of-the-fdas-december-2021-mifepristone-rems-decision">certified medical providers in person</a>.</p>
<p>But in late 2021, the FDA concluded that was no longer necessary for patient safety. Today, the pill, in its original or generic form, is approved for use up to 10 weeks’ gestation and can be <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation">dispensed by a certified prescriber or pharmacy</a>.</p>
<p>Recent lawsuits challenge the scope of the FDA’s authority to regulate the sale of mifepristone.</p>
<p>In one, GenBioPro, a drug company that makes generic mifepristone, <a href="https://www.courtlistener.com/docket/66756764/genbiopro-inc-v-sorsaia/">sued officials in West Virginia</a>, claiming that the state’s abortion ban impedes its sales. GenBioPro argues that the ban contradicts FDA’s approval of and safety requirements for mifepristone, setting up a conflict between federal and state law.</p>
<p>In short, the drugmaker argues that the federal regulations override West Virginia’s abortion restrictions. West Virginia Attorney General Patrick Morrisey, however, <a href="https://www.nytimes.com/2023/01/25/health/abortion-pills-ban-genbiopro.html">plans to defend the abortion ban vigorously because</a> “the U.S. Supreme Court has made it clear that regulating abortion is a state issue.”</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Young women protest restrictions on access to abortion." src="https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=423&fit=crop&dpr=1 600w, https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=423&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=423&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=532&fit=crop&dpr=1 754w, https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=532&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/508729/original/file-20230207-28-3c0zky.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=532&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Protesters in Raleigh, N.C., object to the Supreme Court’s Dobbs ruling on June 25, 2022.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/abortion-rights-demonstrators-gather-to-protest-against-the-news-photo/1241513344?phrase=north%20carolina%20abortion&adppopup=true">Peter Zay/Anadolu Agency via Getty Images</a></span>
</figcaption>
</figure>
<p>In another pending lawsuit, <a href="https://www.courtlistener.com/docket/66756666/bryant-v-stein/">Bryant v. Stein</a>, obstetrician-gynecologist Amy Bryant sued officials in North Carolina on similar grounds. Although North Carolina has not banned abortion, it imposes a number of restrictions, including a 72-hour waiting period before accessing medical or surgical abortions. </p>
<p>Bryant argues that the restrictions exceed the FDA requirements for dispensing mifepristone and are therefore preempted by federal law.</p>
<p>There is limited precedent in this area.</p>
<p>In one case, the manufacturer of an opioid – Zohydro – challenged a Massachusetts ban of the drug, even though the FDA had approved it. The federal court ruled for the manufacturer because the ban would “<a href="https://casetext.com/case/zogenix-inc-v-patrick">obstruct the FDA’s Congressionally-given charge</a>.”</p>
<p>That 2014 opinion might suggest that GenBioPro will succeed. On the other hand, a court might distinguish the two cases: Massachusetts banned Zohydro on public health grounds, which is squarely within the FDA’s authority, while West Virginia bans abortions on moral grounds – to protect fetal life – which is outside the FDA’s purview.</p>
<p>In the North Carolina case, the state does not ban mifepristone; it just imposes more restrictions than the FDA requires. Therefore, it is uncertain whether the Zohydro reasoning would be adopted. </p>
<p>A 2008 Supreme Court case, however, might be relevant.</p>
<p>In <a href="https://www.oyez.org/cases/2008/06-1249">Wyeth v. Levine</a>, a drugmaker claimed that FDA labeling requirements for a drug made by Wyeth, which was used to prevent allergies and motion sickness, preempted Vermont’s stricter labeling requirements. The Supreme Court rejected that argument. It concluded instead that allowing states to require stronger warnings didn’t interfere with Congress’ purpose in entrusting the FDA with drug labeling decisions.</p>
<p>Wyeth is not precisely like Bryant, however.</p>
<p>Whereas Wyeth dealt with labeling requirements, Bryant deals with regulations that affect access to a drug. Nevertheless, the Wyeth precedent could allow a court to permit states to impose stronger restrictions on access to mifepristone – as long as they fall short of banning the drug outright.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A woman in scrubs gives a pill to a woman in black leggings and pink Crocs" src="https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=404&fit=crop&dpr=1 600w, https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=404&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=404&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=508&fit=crop&dpr=1 754w, https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=508&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/509026/original/file-20230208-31-4ocqoh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=508&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Until now, most abortion drugs have been dispensed in person at clinics.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/resident-gives-a-25-year-old-woman-medication-to-terminate-news-photo/1241513931">Gina Ferazzi / Los Angeles Times via Getty Images</a></span>
</figcaption>
</figure>
<h2>Banning mifepristone</h2>
<p>Another pending lawsuit may threaten the FDA’s authority to authorize any sales of mifepristone in the United States. </p>
<p>In <a href="https://adflegal.org/sites/default/files/2022-11/Alliance-for-Hippocratic-Medicine-v-FDA-2022-11-18-Complaint.pdf">Alliance for Hippocratic Medicine v. FDA</a>, a <a href="https://www.nytimes.com/2023/02/05/opinion/republicans-judges-biden.html">group of abortion opponents</a> asked a U.S. district court in November 2022 to force the FDA to stop allowing mifepristone sales anywhere in the United States. The lawsuit argues that the FDA “chose politics over science” and “exceeded its regulatory authority” in various ways, including allegedly disregarding “substantial evidence” that medication abortion is riskier than surgical abortions.</p>
<p>The <a href="https://www.guttmacher.org/2023/02/10-us-states-would-be-hit-especially-hard-nationwide-ban-medication-abortion-using?utm_source=substack&utm_medium=email">consequences could be quite significant</a>, and the issue <a href="https://www.washingtonpost.com/politics/2023/02/05/abortion-pills-texas-lawsuit">could even end up on the Supreme Court’s docket</a> in the future. Nevertheless, there are compelling legal reasons why this lawsuit should fail. </p>
<p><a href="https://www.bloomberglaw.com/public/desktop/document/AllianceforHippocraticMedicineetalvUSFoodandDrugAdministrationeta/1?doc_id=X5HTS5K5059AJ9KRB669CPR0KQ">Some of the same organizations have tried</a> to challenge the FDA’s approval of mifepristone before – without success. And in 2008, <a href="https://www.gao.gov/assets/gao-08-751.pdf">the Government Accountability Office found no irregularities</a> in the FDA’s approval and oversight of mifepristone. </p>
<p>In contradiction to the plaintiffs’ safety argument, <a href="https://doi.org/10.1016/j.contraception.2015.01.005">numerous studies have shown</a> <a href="https://nap.nationalacademies.org/read/24950/chapter/4#53">mifepristone</a> to <a href="https://www.ipas.org/clinical-update/english/recommendations-for-abortion-before-13-weeks-gestation/medical-abortion/safety-and-effectiveness/">be a safe</a> <a href="https://doi.org/10.1097/aog.0000000000000897">and effective</a> <a href="https://doi.org/10.1016/j.jogc.2020.04.006">drug</a>.</p>
<p>Nevertheless, <a href="https://www.vox.com/policy-and-politics/2022/12/17/23512766/supreme-court-matthew-kacsmaryk-judge-trump-abortion-immigration-birth-control">U.S. District Court Judge Matthew Kacsmaryk</a>, who sits in Amarillo, Texas, and is hearing this case regarding whether the FDA should rescind its approval of mifepristone, has not been supportive of reproductive rights in the past. Thus, it is possible that the court could try to stop the FDA from allowing mifepristone to be sold in that part of Texas or even, possibly, across the entire nation.</p>
<p>If the court prevents the sale of mifepristone nationwide, medication abortions would only be possible with the other pill, misoprostol, which is also <a href="https://www.ncbi.nlm.nih.gov/books/NBK539873/#:%7E:text=Currently%2C%20misoprostol%20is%20FDA%20approved,at%20high%20risk%20for%20ulceration">approved for other purposes</a>. Recent data suggests that this one-drug approach to medication abortions may <a href="https://www.theatlantic.com/health/archive/2022/09/abortion-pill-misoprostol-effectiveness/671465/">safely and effectively induce abortion</a>. </p>
<h2>Pills in interstate commerce</h2>
<p>In addition to questions of whether the FDA’s authority can override state-imposed abortion restrictions, there’s a second issue concerning the ability to sell the pills through interstate commerce. </p>
<p>As the <a href="https://perma.cc/M6BA-2ZFZ">Supreme Court has explained</a>, the Constitution <a href="https://www.oyez.org/cases/2011/11-393">grants Congress the authority to regulate</a> “things in interstate commerce,” as well as “those activities that substantially affect interstate commerce.”</p>
<p>Thus, in the GenBioPrio lawsuit pending in West Virginia, the company argues that <a href="https://www.documentcloud.org/documents/23586762-genbiopro-wv-lawsuit">state efforts to restrict sale of the pill are unconstitutional</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Large beige building with a bright green lawn" src="https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/508731/original/file-20230207-16-u1jg3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">An organization that opposes abortion filed a lawsuit in a court located in Amarillo, Texas, that seeks to revoke the FDA’s approval of mifepristone.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/potter-county-courthouse-in-downtown-amarillo-texas-news-photo/1178112126?phrase=amarillo%20district%20court&adppopup=true">Don & Melinda Crawford/Education Images/Universal Images Group via Getty Images</a></span>
</figcaption>
</figure>
<h2>Mailing abortion pills</h2>
<p>Many people are also taking <a href="https://www.plancpills.org/guide-how-to-get-abortion-pills">abortion pills they get through the mail</a>. In response to that trend, <a href="https://www.axios.com/2023/02/01/attorney-general-letter-cvs-walgreens-abortion">20 Republican state attorneys general recently threatened</a>
pharmacies with “legal consequences” if they mail and distribute mifepristone. </p>
<p>An 1873 law, the <a href="https://www.law.cornell.edu/uscode/text/18/1461">Comstock Act</a>, is central to the issue of whether it is legal to mail abortion pills. That law makes it a crime to use the mail for any “lewd, lascivious, indecent, filthy or vile article” as well as any “article, instrument, substance, drug, medicine or thing which is advertised or described in a manner calculated to lead another to use of apply it for producing abortion.”</p>
<p>When the <a href="https://theconversation.com/proposed-federal-abortion-ban-evokes-19th-century-comstock-act-a-law-so-unpopular-it-triggered-the-centurylong-backlash-that-led-to-roe-188681">Comstock Act</a> was enacted, of course, modern delivery services like FedEx and UPS did not exist. But the law also prohibits any “express company” from engaging in the same acts. </p>
<p>The U.S. Postal Service asked the Justice Department whether abortion pills can be mailed under the Comstock Act, and it responded with a <a href="https://www.justice.gov/olc/opinion/file/1560596/download">carefully worded 21-page opinion</a> in late December 2022. The opinion concludes that mailing the abortion pills is not illegal so long as the sender “lacks the intent that the recipient of the drugs will use them unlawfully.” </p>
<p>As the opinion pointed out, recipients could use the drugs for a variety of reasons that would be legal in every state. For example, the combination can “treat a miscarriage,” and misoprostol can prevent and treat <a href="https://www.mayoclinic.org/drugs-supplements/misoprostol-oral-route/side-effects/drg-20064805">gastric ulcers</a>.</p>
<p>Regardless of how Judge Kacsmaryk rules, we expect to see medication abortion remain available in states that don’t have abortion bans. But we also are certain that legal challenges over abortion access will continue.</p><img src="https://counter.theconversation.com/content/198978/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A rash of pending lawsuits raises questions about the FDA’s approval of mifepristone two decades ago, whether the drug can be legally mailed and the constitutional right to interstate commerce.Naomi Cahn, Professor of Law, University of VirginiaSonia Suter, Professor of Law, George Washington UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1973392023-01-11T13:26:42Z2023-01-11T13:26:42ZWhat the FDA’s rule changes allowing the abortion pill mifepristone to be dispensed by pharmacies mean in practice – 5 questions answered<figure><img src="https://images.theconversation.com/files/503684/original/file-20230109-13-cophlz.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C7348%2C4407&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The rule change has little to no effect in states where abortion is banned or restricted.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/simplifying-the-dispensing-process-with-smart-apps-royalty-free-image/1138202173?phrase=pharmacist%20dispensing%20pills&adppopup=true">LaylaBird/E+ via Getty Images</a></span></figcaption></figure><p><em>In early January 2023, the U.S. Food and Drug Administration <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation#">modified its rules for mifepristone</a>, a drug used for medication abortion, allowing it to be offered with a prescription by certified pharmacies. Before this rule change, mifepristone could be dispensed only in person by providers at hospitals, clinics and medical offices, as well as by some mail-order pharmacies.</em></p>
<p><em>The Conversation asked Grace Shih, a family physician practicing in Washington, to explain the significance of this change for health care providers and their patients.</em></p>
<h2>What is mifepristone, and how does it work?</h2>
<p>Mifepristone is a pill that is <a href="https://theconversation.com/what-is-a-medication-or-medical-abortion-5-questions-answered-by-3-doctors-182646">used in medication abortion</a> during early pregnancy. It was initially <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation">approved by the FDA in 2000</a> and is FDA-approved for medication abortion up to 10 weeks after the first day of last menstrual period.</p>
<p>It can be taken as one part of a two-part pill regimen for medication abortion. Mifepristone is prescribed as a 200-milligram dose taken orally followed by an 800-microgram dose of misoprostol, which is placed in the vagina or between the teeth and cheek, where it dissolves and is absorbed, usually 24 to 48 hours later. </p>
<p>Mifepristone acts by blocking the hormone progesterone, which is necessary for a pregnancy to develop. This stops the pregnancy growth and softens and dilates the cervix. It also prepares the uterus for contractions, increasing its sensitivity to medications such as misoprostol. </p>
<p>Misoprostol is a synthetic <a href="https://www.yourhormones.info/hormones/prostaglandins/">prostaglandin</a>. Prostaglandin is a hormonelike substance that has multiple effects, including the stimulation of uterine contractions, which helps expel pregnancy tissue such as the thickened uterine lining and the tissues that are the precursor to the placenta. Mifepristone and misoprostol are also both used in the <a href="https://doi.org/10.1056/NEJMoa1715726">medical management of miscarriage</a>. </p>
<p>Medication abortion can also be done with misoprostol alone, known as the misoprostol-only regimen. In the misoprostol-only regimen, an 800-microgram dose of misoprostol is placed in the vagina or between the teeth and cheek every three hours for up to three doses. </p>
<h2>Why would a person opt for one regimen or the other?</h2>
<p>People usually don’t choose the type of medication abortion they receive. Either mifepristone is available where they are seeking care or it is not. </p>
<p>The American College of Obstetricians and Gynecologists <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">states that</a> “combined mifepristone-misoprostol regimens are recommended as the preferred therapy for medication abortion because they are significantly more effective than misoprostol-only regimens.” </p>
<p>The efficacy <a href="https://doi.org/10.1097/AOG.0000000000000897">of the two-pill regimen is approximately 95% to 98%</a>. However, because mifepristone is under the FDA’s <a href="https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems">risk evaluation and mitigation strategy program</a>, which places <a href="https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=390">specific restrictions on mifepristone</a>, it can be difficult to obtain. </p>
<p>When mifepristone is not available, the American College of Obstetricians and Gynecologists considers the misoprostol-only regimen, which has an efficacy of 76% to 88%, to be an “<a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">acceptable alternative</a>.” Thus, the FDA’s permission to dispense mifepristone at retail pharmacies will help broaden access to the more effective combined mifepristone-misoprostol regimen of medication abortion. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/kzd4ABInBio?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Mifepristone and misoprostol work in tandem to terminate a pregnancy.</span></figcaption>
</figure>
<h2>What will the FDA’s rule change mean in practice?</h2>
<p>The recent FDA change means that retail pharmacies may dispense mifepristone by mail or at brick-and-mortar pharmacies, as long as that retail pharmacy has been certified. In other words, people who live in states where abortion is not banned can take their mifepristone prescription and get it the way they pick up other medications. </p>
<p>For someone able to pick up mifepristone from a local pharmacy, the process will be no different from picking up birth control pills or blood pressure medications. In this way, mifepristone and its uses for abortion care and miscarriage management will be treated as typical health care. </p>
<p>It is unclear whether or how the FDA’s rule will affect state restrictions on abortion care. If medication abortion is not permitted in a specific state, retail pharmacies in that state may or may not be able to dispense mifepristone for abortion care. However, mifepristone could be dispensed from certified pharmacies for reasons unrelated to abortion care, such as miscarriage management.</p>
<h2>What brought about the change?</h2>
<p>On Jan. 3, 2023, the FDA formally modified its <a href="https://www.acog.org/news/news-releases/2020/05/acog-suit-petitions-the-fda-to-remove-burdensome-barriers-to-reproductive-care-during-covid-19">regulations and guidelines around mifepristone use</a>, which were initially proposed during the COVID-19 pandemic. Previous guidelines required that mifepristone be dispensed in person.</p>
<p>These changes were brought about by a <a href="https://www.acog.org/-/media/project/acog/acogorg/files/advocacy/acog-v-fda-complaint-mifepristone-covid19.pdf?">civil complaint</a> that was sponsored by obstetrician-gynecologists, family physicians and reproductive justice advocates. It noted that “of the 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic or medical office,” even though the medication itself can be taken orally by a person unsupervised, at any location. </p>
<p>The in-person requirement meant that those seeking medication abortion or miscarriage care were required to face increased risk of COVID-19 exposure simply to obtain mifepristone. There has been <a href="https://www.acog.org/news/news-releases/2020/05/acog-suit-petitions-the-fda-to-remove-burdensome-barriers-to-reproductive-care-during-covid-19">no documented benefit</a> from this in-person dispensing requirement. </p>
<p>As a result of this complaint, the FDA placed a temporary pause on enforcement of the in-person dispensing requirement and subsequently <a href="https://www.fda.gov/files/drugs/published/Risk-Evaluation-and-Mitigation-Strategies--Modifications-and-Revisions-Guidance-for-Industry.pdf">conducted a formal review</a> of its regulations around the dispensing of mifepristone. The Jan. 3 decision is the FDA’s final decision.</p>
<p>Misoprostol has never been subject to the same restrictions. In addition to its use in the medication abortion regimen, misoprostol is FDA approved for management of gastric ulcers. And it is used, off-label, for cervical dilation and softening when doctors induce labor. People may continue to get their misoprostol at retail or mail-order pharmacies.</p>
<h2>How might this rule change affect medication abortion access?</h2>
<p>While this change is an important step in <a href="https://www.acog.org/news/news-releases/2023/01/statement-fda-announcement-regarding-changes-to-restrictions-on-provision-of-mifepristone">securing access to medication abortion</a>, it does not have a clear benefit for people who live in states where <a href="https://reproductiverights.org/maps/abortion-laws-by-state/">abortion is banned</a>. And it has limited benefit in states that have restrictions on medication abortion. </p>
<p>According to the <a href="https://www.guttmacher.org/">Guttmacher Institute</a>, a reproductive health policy organization, 29 states have <a href="https://www.guttmacher.org/state-policy/explore/medication-abortion">some restriction on medication abortion</a>, including 18 states that require that the clinician providing a medication abortion be physically present with the patient. Those restrictions therefore prohibit the use of telemedicine to prescribe medications for abortion.</p>
<p>It is unclear how many pharmacies will pursue certification and how quickly that certification can happen. Pharmacies that want to dispense mifepristone must comply with <a href="https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=390">FDA pharmacy agreements to achieve certification</a>. </p>
<p>This includes having systems in place to track and verify mifepristone prescribers, using a tracked shipping service and having the ability to report patient deaths to prescribers, <a href="https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_Pharmacy_Agreement_Form_Danco_Laboratories.pdf">among other requirements</a>. CVS and Walgreens have already <a href="https://www.nytimes.com/2023/01/05/health/abortion-pills-cvs-walgreens.html">announced plans to become certified pharmacies</a>.</p>
<p>As a practicing family physician, I see the permanent removal of the in-person dispensing requirement as essential for normalizing abortion care and improving access to medication abortion. However, many obstacles remain, including specific patient consent forms, unique and required prescriber certification and the aforementioned pharmacy certification. </p>
<p>Leading health professional organizations including the <a href="https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications">American College of Obstetricians and Gynecologists</a>, the <a href="https://policysearch.ama-assn.org/policyfinder/detail/mifepristone?uri=%2FAMADoc%2FHOD.xml-H-100.948.xml">American Medical Association</a> and the <a href="https://www.aafp.org/dam/AAFP/documents/events/nc/congress/nc18-ncfmr-actions-referrals.pdf">American Academy of Family Physicians</a> have all issued statements that call for removing all restrictions around mifepristone, since there is no evidence that these restrictions improve patient care or safety.</p><img src="https://counter.theconversation.com/content/197339/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Grace Shih does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The FDA’s allowance for pharmacies to dispense mifepristone will broaden access to the two-pill mifepristone-misoprostol regimen of medication abortion, which is 95% to 98% effective.Grace Shih, Associate Professor of Family Medicine, School of Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1870132022-08-31T12:26:45Z2022-08-31T12:26:45ZWhen abortion at a clinic is not available, 1 in 3 pregnant people say they will do something on their own to end the pregnancy<figure><img src="https://images.theconversation.com/files/478589/original/file-20220810-15-3oc00y.jpg?ixlib=rb-1.1.0&rect=60%2C0%2C6720%2C4325&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A self-managed abortion is the termination of pregnancy outside the formal health care system, often with self-sourced abortion pills.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/young-woman-with-abortion-pill-and-glass-of-water-royalty-free-image/1314748004?adppopup=true">Liudmila Chernetska/iStock via Getty Images Plus</a></span></figcaption></figure><p><em>The <a href="https://theconversation.com/us/topics/research-brief-83231">Research Brief</a> is a short take about interesting academic work.</em> </p>
<h2>The big idea</h2>
<p>One in three people in need of abortion will consider doing something on their own to end the pregnancy if they are unable to get an abortion at a clinic. These are the findings of a <a href="https://doi.org/10.1186/s12978-022-01486-8">study I recently published</a> after surveying over 700 people seeking abortions in three states across the U.S.: Illinois, California and New Mexico.</p>
<p>The one-in-three figure is even higher among those who have a difficult time affording the cost of their abortion, have no health insurance or are seeking an abortion because of concerns about their own physical or mental health. </p>
<p>These findings offer a clear snapshot of what lies ahead as states move to ban abortion outright or severely restrict access. </p>
<h2>Why it matters</h2>
<p>Research over the past two decades has shown that pregnant people who <a href="https://doi.org/10.1016/j.contraception.2021.09.009">face obstacles</a> to getting to an abortion clinic <a href="https://doi.org/10.1016/j.ajog.2020.02.026">or who have a desire</a> for a more natural or private abortion experience will try to end a pregnancy on their own. This might include turning to <a href="https://doi.org/10.1016/j.bpobgyn.2019.08.002">self-sourced abortion pills</a>, alcohol or drugs, herbs or physical methods. </p>
<p>My own research in 2017 found that 7% of U.S. women of reproductive age <a href="https://doi.org/10.1001/jamanetworkopen.2020.29245">will use one of these methods</a> in their lifetime to try to end a pregnancy outside of the formal health care system. </p>
<p>What has changed recently – and dramatically – is access to clinic-based abortion. With the Supreme Court’s decision <a href="https://theconversation.com/supreme-court-overturns-roe-upends-50-years-of-abortion-rights-5-essential-reads-on-what-happens-next-184697">overturning federal protections on abortion access</a>, as of Aug. 30, 2022, 14 states have already <a href="https://reproductiverights.org/maps/abortion-laws-by-state/">implemented bans on abortion</a>; an additional 12 are projected to do so in the coming months. </p>
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<p>These restricted-abortion states are home to just over <a href="https://www.nytimes.com/interactive/2022/05/07/us/abortion-access-roe-v-wade.html">one-half of U.S. women of reproductive age</a>. Putting these numbers together with data on who seeks abortion in the U.S., researchers estimate that over 100,000 pregnant people per year will soon <a href="https://doi.org/10.1016/j.contraception.2019.07.139">face insurmountable travel distances</a> to their nearest abortion provider and be unable to get an abortion at a clinic. </p>
<p>If people do as they project in our study, around 33,000 pregnant people per year will consider doing something on their own to end a pregnancy.</p>
<h2>What still isn’t known</h2>
<p>One yet unanswered question is how many of those in need of abortion and unable to get to a clinic will be able to <a href="https://doi.org/10.1001/jamainternmed.2022.2893">end a pregnancy on their own</a> with a <a href="https://theconversation.com/abortion-pills-are-safe-to-prescribe-without-in-person-exams-new-research-finds-179622">safe and effective method</a> such as the <a href="https://theconversation.com/how-to-navigate-self-managed-abortion-issues-such-as-access-wait-times-and-complications-a-family-physician-explains-186186">FDA-approved medications mifepristone and misoprostol, or misoprostol alone</a> – versus how many will turn to other, likely less effective, methods with potentially harmful outcomes. </p>
<p>Researchers now have clear evidence that <a href="https://doi.org/10.1001/jamanetworkopen.2021.22320">telehealth</a> and <a href="https://doi.org/10.1016/j.lana.2022.100200">mail-order models</a> enabling access to medication abortion <a href="https://doi.org/10.1001/jamainternmed.2022.0217">without the need for an in-person visit</a> with a health care provider – <a href="https://theconversation.com/covid-19-mental-health-telemedicine-was-off-to-a-slow-start-then-the-pandemic-happened-177670">models accelerated in part by the COVID-19 pandemic</a> – are safe, effective and satisfactory to patients.</p>
<p>However, these models will remain out of reach for some. This is especially true for those who are further along in their pregnancy, <a href="https://doi.org/10.1016/j.ssmqr.2021.100003">cannot afford the cost</a>, live in one of the 19 states that <a href="https://www.kff.org/womens-health-policy/slide/state-restrictions-on-telehealth-abortion/">ban telehealth provision of medication abortion</a> or don’t have a safe place to receive and use the pills. </p>
<p>What is also unknown is how many pregnant people will face legal repercussions for doing something to try to end a pregnancy. Although public support <a href="https://doi.org/10.1007/s13178-021-00572-z">for criminalizing a pregnant person</a> for self-managing an abortion is low, state legislators are <a href="https://www.ifwhenhow.org/resources/making-abortion-a-crime-again/">actively proposing such policies</a>. Between 2000 and 2020, more than 61 people were <a href="https://www.ifwhenhow.org/resources/self-care-criminalized-preliminary-findings/">investigated or arrested for such attempts</a>.</p>
<h2>What’s next</h2>
<p>In the coming months, my colleagues and I will document the magnitude of any increase in self-managed abortion by <a href="https://www.ansirh.org/research/ongoing/self-managed-abortion-attitudes-study-smaash">repeating a nationally representative survey</a> that we fielded <a href="https://doi.org/10.1001/jamanetworkopen.2020.29245">in 2017</a> and 2021. </p>
<p>Our research underscores that even when abortion is restricted, people will move forward with abortion on their own. Having access to abortion pills is critical so that when people need to self-manage an abortion, the health, medical and advocacy community is supporting them to do so safely and effectively.</p><img src="https://counter.theconversation.com/content/187013/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lauren Ralph receives funding from the Society of Family Planning Research Fund and an anonymous foundation. </span></em></p>The fall of Roe v. Wade will result in more people deciding to privately end a pregnancy, a new study finds. But how often people will turn to safe versus unsafe options remains to be seen.Lauren Ralph, Associate Professor of Obstetrics, Gynecology and Reproductive Sciences, University of California, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1862782022-08-11T12:15:09Z2022-08-11T12:15:09ZHow primary care is poised to support reproductive health and abortion in the post-Roe era<figure><img src="https://images.theconversation.com/files/478117/original/file-20220808-17-4g635q.jpg?ixlib=rb-1.1.0&rect=69%2C53%2C5048%2C3283&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Primary care providers comprise nearly a third of the U.S. clinician workforce.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/new-jersey-jersey-city-doctor-with-patient-in-royalty-free-image/140193309?adppopup=true">Tetra Images/via Getty Images </a></span></figcaption></figure><p>Just over a month after the <a href="https://theconversation.com/supreme-court-overturns-roe-upends-50-years-of-abortion-rights-5-essential-reads-on-what-happens-next-184697">Supreme Court struck down 50 years of federal protection of abortion rights</a> in the U.S., at least <a href="https://www.guttmacher.org/article/2022/07/one-month-post-roe-least-43-abortion-clinics-across-11-states-have-stopped-offering">43 abortion clinics in 11 states</a> have stopped offering abortion services. In states where abortion remains legal, abortion clinics are experiencing <a href="https://www.nytimes.com/2022/07/23/upshot/abortion-interstate-travel-appointments.html">excessive wait times</a> due to the influx of out-of-state patients. </p>
<p>Wait times are only expected to grow as <a href="https://www.guttmacher.org/state-policy/explore/overview-abortion-laws">more states restrict abortion with regulations</a> such as gestational age limits, waiting periods and requirements for in-person visits, unnecessary clinical tests and required parental consent for minors. Abortion bans and restrictions are associated with higher rates of complications and are <a href="https://www.colorado.edu/today/2021/09/08/study-banning-abortion-would-boost-maternal-mortality-double-digits">harmful to the health of women</a> because they delay necessary care. </p>
<p>Although primary care doctors and clinicians are not typically associated with the abortion debate, they are a critical, untapped resource to help offset the abortion care crisis. Primary care is a key access point for patients, especially for adolescent, low-income and rural women. </p>
<p>And because almost all Americans <a href="https://www.fiercehealthcare.com/practices/89-americans-value-relationship-primary-care-doctor">value their relationship</a> with their primary care provider, primary care has a responsibility to ensure patients <a href="https://doi.org/10.1007/s11606-020-06245-8">maintain personal bodily autonomy</a>, including deciding when and how many children to have. </p>
<p>In the post-Roe era, primary care providers can help their patients prevent unintended pregnancy and avoid delays in abortion care by providing comprehensive contraceptive and family planning services, knowing how to counsel and refer individuals seeking pregnancy termination and providing post-abortion care. Due to various state restrictions, providers should <a href="https://states.guttmacher.org/policies/">familiarize themselves with their specific state regulations</a> to determine what is permissible in their current practice environment.</p>
<p>We are practicing <a href="https://www.uwmedicine.org/bios/emily-godfrey">primary care</a> <a href="https://www.uwmedicine.org/bios/adelaide-hearst">physicians</a> who include comprehensive family planning as part of our practices. We have written extensively about the feasibility of <a href="https://doi.org/10.1007/s11606-021-06863-w">including full-spectrum birth control</a> and first-trimester <a href="https://doi.org/10.1016/j.pop.2018.07.010">abortion services</a> in primary care.</p>
<p>Primary care providers make up 30% of the <a href="https://www.graham-center.org/content/dam/rgc/documents/publications-reports/reports/PrimaryCareChartbook2021.pdf">entire U.S. clinician workforce</a>. They include family physicians, general internists, pediatricians and advanced practice clinicians such as nurse practitioners, midwives and physician assistants, who are often the only source of care in <a href="https://www.ahrq.gov/research/findings/factsheets/primary/pcwork3/index.html">underserved and rural areas</a>. </p>
<h2>Primary care’s role in preventing abortion</h2>
<p>One of the top reasons why patients go to their primary care provider is for birth control. Primary care clinics that provide all-inclusive birth control services <a href="https://upstream.org/results/">reduce unintended pregnancy</a> rates in their communities, which can help alleviate the demand for abortion services. </p>
<p>Primary care providers can talk with their patients about becoming <a href="https://beforeandbeyond.org/toolkit/reproductive-life-plan-assessment">pregnant now or in the future</a>, using <a href="https://powertodecide.org/one-key-question">clinical tools</a> that help patients decide <a href="https://www.mypathtool.org/en/intro_mp">which birth control method</a> to use. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Graphic depiction of the variety of contraception and family planning methods." src="https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/478177/original/file-20220809-20-qqm53q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Contraceptive methods range from IUDs and birth control pills to permanent sterilization.</span>
<span class="attribution"><span class="source">Centers for Disease Control and Prevention</span></span>
</figcaption>
</figure>
<p>Nationally based <a href="https://www.cdc.gov/reproductivehealth/contraception/contraception_guidance.htm">birth control clinical guidelines</a> empower clinicians to prescribe even the most effective birth control methods, such as an implant or intrauterine device – IUD – to patients with serious and chronic medical conditions. Primary care can also help patients with emergency contraception, either in the form of a pill or IUD, within five days after unprotected sex. </p>
<p><a href="https://acrobat.adobe.com/link/track?uri=urn:aaid:scds:US:750761d8-2138-3bd7-bcda-af1b07cc8404">Emergency contraceptive pills</a> are considered safe and effective. They are high-dose birth control pills that work by <a href="https://www.webmd.com/sex/birth-control/faq-questions-emergency-contraception#">interfering with the process of ovulation</a>, and thus will not affect a pregnancy if already pregnant. Emergency contraception is a last chance to prevent unplanned pregnancy.</p>
<h2>Abortion pill prescription falls within primary care</h2>
<p><a href="https://theconversation.com/how-to-navigate-self-managed-abortion-issues-such-as-access-wait-times-and-complications-a-family-physician-explains-186186">Abortion with medications can be safely and effectively used</a> up to the 11th week of pregnancy, with low rates of complications. Of the approximately 1 million legal abortions provided each year in the U.S., 90% occur in the first trimester, or through the 12th week of pregnancy. Thus, it’s no surprise that <a href="https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions">more than half</a> of abortions are now managed with <a href="https://doi.org/10.1007%2Fs11606-020-05836-9">medicines that can be prescribed by a primary care provider</a>. </p>
<p>The <a href="https://nap.nationalacademies.org/catalog/24950/the-safety-and-quality-of-abortion-care-in-the-united-states">National Academies of Sciences, Engineering and Medicine</a> have issued evidence-based guidelines reiterating that trained, licensed primary care clinicians can safely and effectively provide medication abortion. Patients who have received abortions from primary care providers report that they are <a href="https://pubmed.ncbi.nlm.nih.gov/25646981/#">satisfied with the experience</a>. Studies show that patients <a href="https://doi.org/10.1007/s10995-010-0722-4">prefer abortion services in primary care</a> <a href="https://doi.org/10.1016/j.contraception.2009.01.017">because of the privacy</a>, convenience and <a href="https://pubmed.ncbi.nlm.nih.gov/26950663/">continuity of care</a>. </p>
<h2>How abortion care can be integrated into telehealth</h2>
<p>Despite the fact that first-trimester abortion care <a href="https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2012.301119?">fits well within primary care medical services</a>, it has not been widely offered in this setting. This is <a href="https://doi.org/10.3122/jabfm.2022.03.210266">due to roadblocks</a>, including lack of provider training, federal and state legislation, institutional barriers and administrative resistance. </p>
<p>However, there are now new, <a href="https://doi.org/10.1016/j.contraception.2017.11.005">more simplified medication abortion protocols</a> that allow primary care to safely offer abortion care remotely with a <a href="https://doi.org/10.1001/jamainternmed.2022.0217">history screening tool</a> that doesn’t require unnecessary clinical laboratory and ultrasound testing. Primary care’s expansion of telehealth abortion services has the potential to significantly reduce delays in care. This could help reduce abortions at more advanced gestational ages and the complications that come with them. Our study from 2021 conducted among primary care physicians providing telemedicine abortion <a href="https://doi.org/10.1016/j.contraception.2021.04.026">found that more than 85% of patients</a> were less than seven weeks pregnant when they sought care. </p>
<h2>Post-abortion ‘primary’ care</h2>
<p>In states with restricted abortion access, it is inevitable that patients will seek abortions on their own. Given the current legal landscape, clinicians are often confused about how to treat patients with pregnancy complications, including miscarriage. The World Health Organization stresses that even in settings where abortion may be outlawed, it is incumbent for clinicians to provide <a href="https://srhr.org/abortioncare/chapter-3/post-abortion-3-5/">compassionate, nonjudgmental post-abortion care</a>. </p>
<p>Post-abortion care includes managing residual side effects or complications of abortion, as well as the provision of comprehensive birth control services without discrimination or coercion. Complications from abortion or miscarriage are rare. However, complications like retained pregnancy tissue in the uterus, bleeding or infection can occur, most of which can be managed by primary care providers in the clinical setting. </p>
<p>Primary care providers who don’t offer abortion care can still counsel patients about <a href="https://www.abortionfinder.org/">where to seek</a> reliable, high-quality abortion services. The U.S. Department of Health and Human Services provides information about <a href="https://reproductiverights.gov/">Americans’ rights to reproductive health care</a>. </p>
<p>The short-term implications of the Supreme Court decision remain uncertain as state legislators weigh public opinion among their constituents. </p>
<p>What remains certain in the post-Roe era, however, is that primary care continues to be among the most reliable resources in the U.S. for accurate information and safe reproductive health care services.</p><img src="https://counter.theconversation.com/content/186278/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Emily M. Godfrey receives funding from Cystic Fibrosis Foundation and Society of Family Planning Research Fund. She is a Nexplanon Trainer for Organon</span></em></p><p class="fine-print"><em><span>Adelaide H. McClintock is the named institutional PI for a grant from the Society of Family Planning. This grant was officially awarded to Nina Tan. </span></em></p>Primary care doctors have long played an important role in providing birth control. Now, with the fall of Roe, they could help fill a critical need for comprehensive family planning services.Emily M. Godfrey, Associate Professor of Family Medicine and Obstetrics & Gynecology, School of Medicine, University of WashingtonAdelaide H. McClintock, Professor of Internal Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1826462022-05-24T12:28:12Z2022-05-24T12:28:12ZWhat is a medication, or medical, abortion? 5 questions answered by 3 doctors<figure><img src="https://images.theconversation.com/files/462550/original/file-20220511-12-8ukbgc.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C3994%2C2730&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The mifepristone pill is one option for medication abortion that can be purchased online and used at home.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/in-this-photo-illustration-a-person-looks-at-an-abortion-news-photo/1212435851">Olivier Douliery/AFP via Getty Images</a></span></figcaption></figure><p><em>With the Supreme Court allowing states to ban abortion, many questions have been raised about “abortion pills” – medication used to deliberately end a pregnancy. Prior to the court’s decision, on May 4, 2022, <a href="https://www.sciline.org/">SciLine</a>, a nonprofit, independent service that connects scientists to journalists, interviewed three medical experts to answer questions about medication abortions: <a href="https://bixbycenter.ucsf.edu/claire-brindis-drph">Dr. Claire Brindis</a> is the founding director of the Bixby Center for Global Reproductive Health and a professor in the school of Medicine at University of California, San Francisco. <a href="https://profiles.ucsf.edu/daniel.grossman">Dr. Daniel Grossman</a> is the director of Advancing New Standards in Reproductive Health and a professor of obstetrics, gynecology and reproductive sciences at University of California, San Francisco. <a href="https://ihpi.umich.edu/our-experts/laureno">Dr. Lauren Owens</a> is a fellow of the American College of Obstetricians and Gynecologists and an assistant professor of obstetrics and gynecology at University of Michigan Medical School.</em></p>
<p><em>The Conversation has collaborated with <a href="https://www.sciline.org/">SciLine</a> to bring you highlights from the discussion, which have been edited for brevity and clarity.</em></p>
<p><strong>How effective are medication abortions?</strong></p>
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<p><strong>Claire Brindis:</strong> Research has shown us that medical abortions are as effective as surgical abortions, but we want to use medical abortion earlier in the pregnancy. It’s especially effective up to 10 weeks of pregnancy.</p>
<p><strong>Daniel Grossman::</strong> The most commonly used regimen for medication abortion in the United States involves two medications: <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information">mifepristone</a> followed by <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/misoprostol-marketed-cytotec-information">misoprostol</a>, which is approved by the U.S. Food and Drug Administration for use up through 10 weeks of pregnancy. There is evidence about its safe use up until about 11 or even 12 weeks, but overall these medications are <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">about 97% effective</a> – meaning that about 3% of people who use them will need to have a vacuum aspiration or a procedural abortion to complete the abortion.</p>
<p><strong>Lauren Owens:</strong> Medication abortions are highly effective. The <a href="https://doi.org/10.1016/j.contraception.2019.05.006">best data</a> <a href="https://doi.org/10.1016/j.contraception.2020.05.012">we have</a> – and how I counsel my patients – is that medication abortions are more than 95% effective. </p>
<p><strong>What are the possible complications from medication abortions? Are they common?</strong></p>
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<p><strong>Brindis:</strong> We have found that medical abortions have had a <a href="https://doi.org/10.1016/j.contraception.2012.06.011">very low incidence</a> of any type of complications. Less than 1 percent – 0.4% of women – experience any kinds of additional complications, such as heavier bleeding, low-grade fevers and some additional pelvic pain that over time is eliminated.</p>
<p><strong>Grossman:</strong> Abortion using medications is very safe. This has been very well studied, and really millions of patients have now used it in the U.S. Serious complications are very rare; they occur in less than half a percent.</p>
<p><strong>How does the safety of telehealth medication abortions compare to medication abortions performed in a clinical setting?</strong></p>
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<p><strong>Owens:</strong> We know that telemedicine medication abortion is really equivalent to a clinical setting, as far as outcomes. We have really great data out of Iowa from Dr. <a href="https://pubmed.ncbi.nlm.nih.gov/28885427/">Daniel Grossman</a>, [and] from <a href="https://doi.org/10.1016/j.contraception.2019.05.013">Dr. Elizabeth Raymond at Gynuity</a> [Health Projects]. I perform my care in Michigan, which is a state that does have telemedicine medication abortion, which [I believe] is a great service to offer people, as folks who live rurally may have more barriers to care than other people.</p>
<p><strong>Grossman:</strong> Telehealth has expanded in really every area of medicine, including for providing medication abortion. And there are now several published studies, both from <a href="https://doi.org/10.1111/1471-0528.16668">the United Kingdom</a> and now from <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790319">the United States</a>, showing that safety and effectiveness outcomes are really pretty much identical with medication abortion provided by telehealth compared to in-person provision.</p>
<p><strong>How safe are medication abortions performed at home without medical supervision?</strong></p>
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<p><strong>Grossman:</strong> People have been self-managing their abortions for hundreds, if not thousands, of years. The difference now is that people have the option of using these same medications which they may obtain online or from pharmacies in some countries or from a variety of sources. And all of <a href="https://doi.org/10.1016/j.lana.2022.100200">the evidence</a> <a href="https://doi.org/10.1016/S2214-109X(21)00461-7">that we have</a> so far indicates that self-managed abortion using these medications is very safe. And that people will seek care from a clinician if they have a question or concern about a complication.</p>
<p><strong>Brindis:</strong> Based upon previous research, I don’t anticipate that there are many more complications for women using these medications at home to perform an early abortion. One thing that is very important to recognize is that many of these women are savvy consumers of knowledge and information. They will seek out advice either from friends who’ve already had one or from other internet resources that help them prepare for what to expect, first, before, during and after.</p>
<p><strong>Owens:</strong> I really think medication abortion exists on a spectrum. So when we think about an “in-clinic” medication abortion, folks are frequently getting a first pill in clinic and then taking the second pills at home. So even though that’s clinically done at the start, really the procedure is completed at home. There are some <a href="https://doi.org/10.1016/j.lana.2022.100200">really great data</a> with almost 3,000 folks showing that there are really similar outcomes with self-managed versus in-clinic medication abortion.</p>
<p><strong>What are the physical effects of medication abortions? Are any long-lasting?</strong></p>
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<p><strong>Brindis:</strong> The physical effects of using these medications are short-term. They really are only around the time of the abortion. And they’re not long-lasting in the women’s body.</p>
<p><strong>Grossman:</strong> The medications have the effect of causing cramping and bleeding that leads to expulsion of the pregnancy. I will say that the side effects of the regimen can be intense for some people, particularly the pain. The medication can have other side effects like nausea, vomiting, diarrhea, sometimes people have fevers or chills right after taking particularly the second medication, misoprostol. In general, these side effects are very short-lived, and there are <a href="https://nap.nationalacademies.org/catalog/24950/the-safety-and-quality-of-abortion-care-in-the-united-states">no long-term risks</a>. There are no risks to fertility in the future or risks of complications of a future pregnancy. </p>
<p><strong>Owens:</strong> I see a lot of patients who are worried about what having an abortion could mean for their future fertility, and medication abortion should not have any impact on future pregnancies.</p>
<p><em><a href="https://www.sciline.org/">SciLine</a> is a free service based at the nonprofit American Association for the Advancement of Science that helps journalists include scientific evidence and experts in their news stories.</em></p><img src="https://counter.theconversation.com/content/182646/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lauren Owens is the advocacy co-chair for the Michigan Section of the American College of Obstetricians and Gynecologists.</span></em></p><p class="fine-print"><em><span>Daniel Grossman receives funding from foundations, including the David and Lucile Packard Foundation and the William and Flora Hewlett Foundation.</span></em></p><p class="fine-print"><em><span>Claire Brindis does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Three experts answer questions about the effectiveness, safety and side effects of medication abortion, using mifepristone followed by misoprostol.Lauren Owens, Clinical Assistant Professor, University of MichiganClaire Brindis, Distinguished Professor of Medicine, University of California, San FranciscoDaniel Grossman, Professor of Obstetrics, Gynecology & Reproductive Sciences, University of California, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1796222022-03-21T22:28:53Z2022-03-21T22:28:53ZAbortion pills are safe to prescribe without in-person exams, new research finds<figure><img src="https://images.theconversation.com/files/453355/original/file-20220321-19-28trjd.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Removing ultrasound and pelvic exam requirements for medication abortion could help expand access to care.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/two-pills-in-an-orange-pink-background-medical-royalty-free-image/1310155813">Oleg Rebrik/iStock via Getty Images Plus</a></span></figcaption></figure><p>For many people, accessing abortion care can be a major challenge. Abortion services are usually only available in certain clinics with specialized equipment like ultrasounds, often requiring long-distance travel to get there. When <a href="https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/">medication abortion</a>, or abortion with pills, was introduced to the U.S. in 2000, it offered a more accessible option to end pregnancy. </p>
<p>However, medication abortion was initially <a href="https://doi.org/10.1056/NEJMsb1612526">highly regulated</a> and could only be dispensed in person at abortion clinics. Guidelines also required an ultrasound to confirm that the patient was less than 11 weeks pregnant and not <a href="https://www.mayoclinic.org/diseases-conditions/ectopic-pregnancy/symptoms-causes/syc-20372088">ectopic</a>, meaning having a pregnancy where the fertilized egg implants outside the uterus and can result in a life-threatening miscarriage. </p>
<p>Due to the pandemic, however, a <a href="https://doi.org/10.1016/j.contraception.2020.04.005">new screening model</a> emerged that relies only on a patient’s medical history to confirm their eligibility for medication abortion. This means that patients don’t need to undergo an in-person pelvic exam or ultrasound. They can even have their medication mailed to them after a <a href="https://doi.org/10.1001/jamanetworkopen.2021.22320">remote telehealth consultation</a> with a clinician. The U.S. Food and Drug Administration also <a href="https://doi.org/10.1016/j.ptdy.2022.02.008">permanently allowed mail-order pharmacies</a> to ship abortion medications to patients.</p>
<p>As a <a href="https://profiles.ucsf.edu/ushma.upadhyay">public health social scientist</a> who has studied abortion safety and access for over a decade, I wanted to see how this new care model compared to its predecessor. In our <a href="https://doi.org/10.1001/jamainternmed.2022.0217">new study</a>, my colleagues and I found that screening for a patient’s eligibility based on their medical history instead of physical exam or ultrasound was just as safe and effective as in-person tests and exams.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/h6PvzSsViR8?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">In December 2021, the FDA permanently ruled that medication abortion could be received by mail after a remote telehealth consultation.</span></figcaption>
</figure>
<h2>The data on remote telehealth consultations</h2>
<p>To compare the safety and effectiveness of these two care models, my colleagues and I collected the medical chart data of nearly 3,800 patients from 14 clinics across the U.S. About 66% of the patients saw a clinician in person and picked up their medication at the clinic, while 34% had a remote telehealth visit and received their medications via mail. None of the patients in either group received a screening physical exam or ultrasound.</p>
<p>We reviewed the data for any adverse events or problems patients may have had after taking the abortion pills. Overall, we found that 95% of patients completed their abortions without additional intervention. This is comparable to completion rates from <a href="https://doi.org/10.1097/AOG.0000000000000603">previous</a> <a href="https://doi.org/10.1016/j.contraception.2015.01.005">studies</a> <a href="https://doi.org/10.1016/j.contraception.2019.05.013">on</a> medication abortion prescribed after in-person ultrasounds and exams. Only 0.5% of patients experienced a serious adverse event, also comparable to <a href="https://doi.org/0.1097/AOG.0000000000000603">previously</a> <a href="http://doi.org/10.1097/AOG.0b013e3182755763">reported</a> rates after in-person exams. </p>
<p>We also found no significant difference in effectiveness or safety between the group that picked up their abortion pills in person and those who received them by mail after a telehealth consultation.</p>
<p>Overall, we found that medication abortions dispensed after reviewing a patient’s medical history are just as safe and effective as those prescribed after an in-person pelvic exam and ultrasound.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Close-up of person receiving abdominal ultrasound exam." src="https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/453377/original/file-20220321-17-1th3ucq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Medication abortion can be prescribed safely without an ultrasound.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/mid-adult-woman-having-abdominal-ultrasound-royalty-free-image/166510504?adppopup=true">svega/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<h2>Expanding access to equitable care</h2>
<p>With a <a href="https://doi.org/10.2196/jmir.9717">limited number of clinics and providers</a>, <a href="https://doi.org/10.1016/j.socscimed.2021.113747">insurance coverage bans</a> and <a href="https://doi.org/10.1016/j.socscimed.2021.113747">state restrictions</a>, people seeking abortions face significant barriers to obtaining the care they need. These <a href="https://doi.org/10.1016/j.contraception.2021.05.001">barriers</a> <a href="https://doi.org/10.1377/hlthaff.2021.01422">disproportionately</a> <a href="https://doi.org/10.1016/j.whi.2021.09.005">affect</a> people of color, low-income groups and other marginalized people.</p>
<p>If <a href="https://theconversation.com/will-roe-v-wade-be-overturned-and-what-would-this-mean-the-us-abortion-debate-explained-173156">Roe v. Wade</a> is overturned or significantly altered, <a href="https://www.nytimes.com/interactive/2021/05/18/upshot/abortion-laws-roe-wade-states.html">almost half the country</a> will face even more difficulties accessing abortion care.</p>
<p>Minimizing in-person tests by shifting toward remote screening, however, could expand access to abortion care to more patients. Because no special equipment like ultrasound machines are needed, more clinicians can write a prescription for the pills. <a href="https://doi.org/10.1089/jwh.2009.1454">Primary care</a> <a href="https://doi.org/10.1016/j.pop.2018.07.010">providers</a> who work in rural, low-income and other marginalized communities could conduct medication abortion screening and increase equitable access to abortion care.</p>
<p>The <a href="https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2020/10/medication-abortion-up-to-70-days-of-gestation">American College of Obstetricians and Gynecologists</a> and the <a href="https://prochoice.org/providers/quality-standards/">National Abortion Federation</a> have already updated their guidelines to reflect the fact that medical history review without an in-person pelvic exam and ultrasound is sufficient to confirm medication abortion eligibility.</p>
<p>But it is important to note that state restrictions prevent this new care model from being implemented nationwide. <a href="https://www.guttmacher.org/state-policy/explore/requirements-ultrasound">Some states</a> legally require ultrasounds, and <a href="https://www.guttmacher.org/state-policy/explore/medication-abortion">other states</a> either require an in-person visit or prohibit telehealth screenings. As the high safety and effectiveness rates from <a href="https://doi.org/10.1001/jamainternmed.2022.0217">our study</a> and <a href="https://doi.org/10.1001/jamanetworkopen.2021.22320">other</a> <a href="https://doi.org/10.1016/j.contraception.2021.03.019">ones</a> show, these laws are not based on scientific evidence and <a href="https://journalofethics.ama-assn.org/article/mandated-ultrasound-prior-abortion/2014-04">medical necessity</a> as they claim.</p>
<p>While this new model was originally introduced to reduce physical contact during the pandemic, it could help remove barriers to medication abortion and expand access to equitable care for all patients.</p>
<p>[<em>Understand new developments in science, health and technology, each week.</em> <a href="https://memberservices.theconversation.com/newsletters/?nl=science&source=inline-science-understand">Subscribe to The Conversation’s science newsletter</a>.]</p><img src="https://counter.theconversation.com/content/179622/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ushma Upadhyay received funding for this study from the BaSe Family Fund and University of California, Global Health Institute's Center of Expertise in Women's Health, Gender, and Empowerment. </span></em></p>During the pandemic, health care providers began prescribing abortion pills without requiring in-person exams. This practice could help people access the care they need when abortion rights are in limbo.Ushma Upadhyay, Associate Professor of Obstetrics, Gynecology & Reproductive Science, University of California, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1676102021-09-22T12:55:59Z2021-09-22T12:55:59ZStudy shows an abortion ban may lead to a 21% increase in pregnancy-related deaths<figure><img src="https://images.theconversation.com/files/420920/original/file-20210913-25-107aakk.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1024%2C683&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Banning abortion can have health consequences for pregnant people.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/woman-carries-a-sign-declaring-abortion-a-part-of-news-photo/1235196693">Jordan Vonderhaar/Stringer via Getty Images News</a></span></figcaption></figure><figure class="align-center ">
<img alt="White text on green background stating '21%: Estimated increase in pregnancy-related deaths by the second year of a nationwide abortion ban in the US.'" src="https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=255&fit=crop&dpr=1 600w, https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=255&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=255&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=321&fit=crop&dpr=1 754w, https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=321&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/422479/original/file-20210921-25-1k8bj57.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=321&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
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<p>A <a href="https://www.texastribune.org/2021/09/01/texas-abortion-clinic-follow-new-law/">new Texas law</a> bans nearly all abortions, and other states have indicated that they likely will <a href="https://www.nbcnews.com/news/us-news/just-beginning-after-texas-victory-anti-abortion-rights-activists-could-n1278492">follow suit</a>. But the research is clear that people who want abortions but are unable to get them can suffer a slew of <a href="https://www.ansirh.org/research/ongoing/turnaway-study">negative consequences for their health and well-being</a>. </p>
<p>As a <a href="https://scholar.google.com/citations?user=YTK30lUAAAAJ&hl=en&oi=ao">researcher who measures the effects of contraception and abortion policy on people’s lives</a>, I usually have to wait years for the data to roll in. But sometimes anticipating a policy’s effects before they happen can suggest ways to avoid its worst consequences.</p>
<p>In my forthcoming peer-reviewed paper, <a href="https://doi.org/10.31235/osf.io/sb5f2">currently available as a preprint</a>, I found that if the U.S. ends all abortions nationwide, pregnancy-related deaths will increase substantially because carrying a pregnancy to term can be deadlier than having an abortion.</p>
<h2>Pregnancy is riskier than abortion</h2>
<p>Banning abortion does not stop people from trying to end their pregnancies. But it won’t result in a return to the kinds of unsafe abortion that <a href="https://www.washingtonpost.com/politics/2019/05/29/planned-parenthoods-false-stat-thousands-women-died-every-year-before-roe/">killed hundreds of women per year</a> before the Supreme Court’s ruling Roe v. Wade legalized abortion in the U.S. </p>
<p>Recent advances in <a href="https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/">medication abortion</a>, which relies on prescription drugs rather than a procedure, have made safer abortions outside of clinics possible. They set the stage for organizations like <a href="https://www.plancpills.org">Plan C</a> to help pregnant people safely <a href="https://www.plannedparenthood.org/learn/abortion/the-abortion-pill">manage their own abortions with pills</a> if they want or need to.</p>
<p>Staying pregnant, on the other hand, carries a greater risk of death for the pregnant person than having an abortion. Abortion is incredibly safe for pregnant people in the U.S., with <a href="http://dx.doi.org/10.15585/mmwr.ss6907a1">0.44 deaths per 100,000 procedures from 2013 to 2017</a>. In contrast, <a href="https://www.cdc.gov/nchs/data/hestat/maternal-mortality-2021/E-Stat-Maternal-Mortality-Rates-H.pdf">20.1 deaths per 100,000 live births occurred in 2019</a>. In the U.S., pregnancy-related deaths occur for <a href="https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm">many reasons</a>, including cardiovascular conditions, infections and hemorrhage caused or worsened by being pregnant or giving birth.</p>
<h2>One possible future with an abortion ban</h2>
<p>Policies like the <a href="https://news.trust.org/item/20201231112641-qfynt/">abortion bans sweeping the U.S.</a> may affect pregnancy-related deaths in several ways. In <a href="https://doi.org/10.31235/osf.io/sb5f2">my study</a>, I estimated a portion of the additional deaths that would be caused by a nationwide ban on all abortions.</p>
<p>To do this, I used published U.S. pregnancy and abortion death rates to project how many deaths would occur if all pregnancies that currently end in abortion were instead continued to miscarriage or term. My conservative estimate found that the annual number of pregnancy-related deaths would <a href="https://osf.io/preprints/socarxiv/sb5f2/">increase by 21% overall</a>, or 140 additional deaths, by the second year after a ban. </p>
<p>Among non-Hispanic Black woman, this percentage would increase 33%, causing 78 additional deaths and exacerbating the ongoing U.S. <a href="https://www.hsph.harvard.edu/magazine/magazine_article/america-is-failing-its-black-mothers/">Black maternal health crisis</a>. The pregnancy-related death rate for non-Hispanic Black women is about <a href="https://www.cdc.gov/nchs/data/hestat/maternal-mortality-2021/E-Stat-Maternal-Mortality-Rates-H.pdf">three times higher</a> than for non-Hispanic white women and Hispanic or Latino women, likely because of <a href="https://doi.org/10.1089/jwh.2020.8882">structural racism</a>, <a href="https://doi.org/10.1186/s12978-019-0729-2">biases in health care provision</a> and disparities in health care access, among other reasons.</p>
<p><iframe id="syj9j" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/syj9j/4/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>In reality, these figures could be higher. They do not account for the fact that <a href="https://doi.org/10.1363/46e0414">people having abortions</a> are on average <a href="https://doi.org/10.1097/AOG.0b013e31823fe923">less advantaged than people having births</a> and at a higher risk of pregnancy-related death. Nor do they include the risks of using less safe abortion methods.</p>
<h2>This possible future does not have to come true</h2>
<p>Projections always rely on assumptions about how the future will unfold – they are warnings, not predictions. My estimates describe how deaths would increase if everyone who currently has abortions instead carries their pregnancy to term.</p>
<p>But the federal government, other states and nongovernmental organizations could make state abortion bans less deadly. </p>
<p>The assumptions behind my projections show us how to prevent what I warn could happen. For example, effectively addressing the <a href="https://doi.org/10.26099/411v-9255">maternal health crisis</a> could make pregnancy safer and reduce pregnancy-related deaths. Helping people <a href="https://www.nbcnews.com/think/opinion/texas-abortion-crisis-proves-abortion-pill-needs-be-every-drug-ncna1278829">access safe medication abortion</a> and <a href="https://www.npr.org/sections/health-shots/2021/08/02/1022860226/long-drives-costly-flights-and-wearying-waits-what-abortion-requires-in-the-sout">travel across state lines</a> to get to an abortion clinic would reduce pregnancy-related deaths. And not banning abortion in the first place would reduce pregnancy-related deaths the most.</p><img src="https://counter.theconversation.com/content/167610/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Amanda Jean Stevenson receives funding from the William and Flora Hewlett Foundation and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Her statements do not represent those of her funders.</span></em></p>Carrying a pregnancy to term is riskier than having an abortion, especially for non-Hispanic Black women.Amanda Jean Stevenson, Assistant Professor of Sociology, University of Colorado BoulderLicensed as Creative Commons – attribution, no derivatives.