Nearly One-Third of FDA Approved Drugs Pose Safety Risks

The film adaptation of Richard Matheson’s novel “I am Legend” is based on a simple premise: Scientists discover what appears to be a cure for cancer, and the whole world goes to hell as a result. Sure, the treatment had proven successful on the handful of trial patients it had been tested on, so why not rush it to market? What could go wrong? Who could have known that “zombie apocalypse” was one of the side effects?

Modern medicine has undoubtedly improved the lives of countless people worldwide. But with the pharmaceutical industry raking in billions of dollars each year, big business often dictates that the next blockbuster drug must get into the hands of consumers as quickly as possible.

What could go wrong?

A lot, as it turns out.

A recent study published in JAMA shows that 32% of FDA approved drugs from 2001 through 2010 posed safety risks to consumers that were only discovered after they had been approved.

The study, which reviewed 222 products that the FDA approved, found that the administration took some sort of action to deal with safety issues that arose from nearly one-third of the products that had been cleared for sale. Of those, three drugs were removed from the market, 59 were the subject of safety communications to doctors and consumers, and 61 were issued black box warnings, the FDA’s most serious safety alert.

How is it possible that the FDA – the organization whose own mission statement charges the agency with protecting public health by assuring the safety of food and drugs – wasn’t able to catch these risks before approving the drugs?

Joseph Ross, the lead author of the study and an associate professor of medicine and public health at Yale University expounded on this problem in an interview with the Washington Post:

“We seem to have decided as a society that we want drugs reviewed faster,” said Ross.

This rush-to-the–market sentiment has been echoed by many, including current US President Donald Trump, who called the current FDA approval process “slow and burdensome.” However, the current approval process is faster than it’s ever been before thanks to the administration’s Accelerated Approval Program.  This program grants a “fast lane” for approving drugs that treat serious conditions or fill an unmet medical need. Unsurprisingly, the JAMA study also found that the treatments most likely to be flagged for safety concerns were also cleared under the Accelerated Approval Program.

Ultimately, the study concluded that there is a need for continuous monitoring of safety issues throughout the life cycle of a drug. It can be difficult to get a real-world representation of a drug’s effects based only on a small sample group tested over a short duration. Based on our experience helping clients who have been harmed by drugs and devices like hernia mesh, Essure, testosterone medication and blood thinners, the race to reach the market first is often more important than who gets trampled underfoot to many manufacturers.