When regulatory agencies like Health Canada approve a new drug, they require the drug company to continue monitoring the product’s safety.
Health Canada continues to monitor newly approved drugs to determine if the benefits identified in the pre-market trials hold up to further scrutiny. Canadians need better access to that information.
In addition to evaluating new drug applications, the FDA also inspects drug manufacturing facilities.
The U.S. Food and Drug Administration/Flickr
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.
The pharma industry warned that if proposed new prescription price guidelines go ahead, drug launches would be delayed and ‘Canadian patients will be deprived of potentially life-saving new medicines.’
The pharma industry claims lower prescription drug prices will mean less access to new medication for Canadians. It’s an old threat that pits profits against patients’ rights to affordable drugs.
The HIV prevention drug cabotegravir, which is delivery by injection every eight weeks, is not yet available in Canada.
The next step in HIV prevention — long-acting injectable pre-exposure prophylaxis (PrEP) — is not yet available in Canada, a year after its approval in the U.S.
Canadian doctors don’t have easy access to newer antibiotics, and must prescribe older, generic treatments that are increasingly ineffective due to resistance.
Canada lags behind other developed countries in access to newer antimicrobials. Here’s why that matters, and what can be done about it.
The level of evidence for withdrawing a drug does not appear to affect the pharma company’s response.
When drugs are taken off the market because they are either unsafe or don’t work, do pharma companies admit that there are problems? Or do they deny the evidence?
Aducanumab (Aduhelm) was approved in the U.S., but there is no convincing evidence the drug will help Alzheimer’s patients.
FDA approval of aducanumab (Aduhelm) was contentious. Its submission to Health Canada for approval highlights concerns about evidence, independence and transparency in Canada’s drug approval process.
The scope and length of vaccine testing experiments usually mean decade-long timelines for development.
It usually takes 10 years for a new vaccine to complete clinical trials, but we’ve been promised a COVID-19 vaccine in 12 to 18 months. Even if such fast-tracked development is possible, is it wise?
The matchstick-size implant is shown here with an insertion device.
Nexplanon, a long-acting reversible contraceptive that is implanted in the arm for up to three years, is a welcome addition to birth control options in Canada.
The effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn’t necessarily equate to improved survival rates.
National drug regulators use evidence from clinical trials to decide whether new cancer drugs will be approved for use. But these studies are often flawed.
Health Canada’s intention to increase the fees drug makers pay for the drug approval process threatens to compromise drug safety and the health of the Canadian public.
Health Canada proposes to increase fees to the pharmaceutical industry for prescription drug approval. This will compromise drug safety and is a risk to the health of the Canadian public.
Tourism isn’t just for sunshine and beaches. It can also be for unapproved medical interventions.
IV via ARZTSAMUI/Shutterstock
Medical tourism is the practice of seeking medical care across international borders. Countries with established medical sectors like the US, Europe, India and Thailand have been traditional destinations…
Who pays for experimental treatments? Stock image from
In the last six months Colorado, Louisiana, Missouri, Michigan and, most recently, Arizona have passed “right to try” laws that allow terminally ill patients to access treatments that have only passed…
What if an experimental treatment seems to hold a terminal patient’s only hope?
Pill bottle image via www.shutterstock.com
On November 4, the state of Arizona will decide whether to join Colorado, Missouri, Louisiana and Michigan in passing so-called right to try laws. If passed, the “Arizona Terminal Patients’ Right To Try…
Pills, spills and development aches.
Developing new drugs is hard and expensive. The lengthy process from initial discovery to the market is some times compared to the difficulty of putting a person on the moon. Despite accusations that the…
Signed, sealed, delivered, not yours.
Between 2005 and 2011, nearly half of all new drug formulations in the US were approved without companies having to demonstrate a tangible benefit, such as relieving disease symptoms, extending life, or…