Nearly One in Three FDA-Approved Medicines Later Found Unsafe

It happens more often than it should: Patients experience serious or even fatal complications during clinical trials for not-yet-approved medicines. But complications can also happen after the Food and Drug Administration (FDA) approves the drug and it is sold to patients.

Drugs should be tested using human biology-based methods such as tissue chips and modeling approaches to give us a better sense of how humans will react to the treatment. Animal tests simply can’t ensure safe medicines, but the FDA still requires animal tests for all new medicines.

A study published this week confirms the scope of the problem. Doctors found that 32 percent of FDA-approved medicines from 2000 to 2010 were “affected by a postmarket safety event.” This means they were either withdrawn, required black box warnings, or led to FDA safety communications after patients began taking them.

The study raises concern about how well medical products are tested, particularly given recent pressure on the FDA to speed up the approval process. One way to speed the approval of safer treatments is to accept modern tests that are based on human biology.

The Physicians Committee is working to make testing faster and more human-relevant. We support the development of new approaches and train regulators how to use them. Additionally, we are working with lawmakers and leading patient safety groups to change FDA regulations and National Institutes of Health funding practices. These science, policy, and educational advances will help safeguard patients by giving the FDA better information before approval decisions are made.

Want to learn more? Check out this episode of The Exam Room to hear our experts discuss medical safety: