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Articles on Drug approval

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Health Canada’s new drug licensing proposal contains no mechanism for making fast-tracked medicines affordable. THE CANADIAN PRESS/Ryan Remiorz

Canada’s misguided changes to drug regulation could fast-track unproven medications and divert funds from other health needs

The federal government’s proposed Agile Licensing drug approval regulations mean Canada will have less information about the risks of new medicines, and higher costs.
When regulatory agencies like Health Canada approve a new drug, they require the drug company to continue monitoring the product’s safety. (Shutterstock)

Health Canada should be transparent about how it’s monitoring drug 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

Challenging the FDA’s authority isn’t new – the agency’s history shows what’s at stake when drug regulation is in limbo

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.’ (Shutterstock)

How the pharmaceutical industry uses disinformation to undermine drug price reform

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. (Shutterstock)

Long-acting injectable PrEP is a big step forward in HIV prevention

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.
The scope and length of vaccine testing experiments usually mean decade-long timelines for development. (Pixabay)

Fast COVID-19 vaccine timelines are unrealistic and put the integrity of scientists at risk

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 effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn’t necessarily equate to improved survival rates. From shutterstock.com

Do new cancer drugs work? Too often we don’t really know (and neither does your doctor)

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. (Shutterstock)

Your prescription drugs are about to become less safe if Health Canada has its way

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 treatment not approved yet? No problem! Welcome to circumvention tourism

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…
What if an experimental treatment seems to hold a terminal patient’s only hope? Pill bottle image via www.shutterstock.com

‘Right to try’ laws are compassionate, but misguided

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. ep_jhu

Why there may be fewer truly new drugs hitting the market

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…

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