Consumer groups, health experts call for better oversight for certain approved medications

Congress will spend the summer reviewing changes to how drugs are reviewed and approved by the Food and Drug Administration. We joined a broad coalition in a letter to urge Congress to include stronger oversight of certain drugs that come to our pharmacy shelves through “accelerated approval.” 

To get certain drugs to patients faster, the FDA is allowed to accept a lower standard of proof that the drug is safe and effective. But the drug companies are then supposed to conduct a full post-market clinical trial to ensure the medication truly works to make patients healthier. Our letter points out that drug companies have not consistently started or completed these required post-market trials, meaning “too many products have lingered on the market and potentially endangered patients who continue to take these medications.” 

“It is time to fix the proven problems that have arisen under the accelerated approval pathway,” said Patricia Kelmar, U.S. PIRG’s health care campaigns director. “Swifter approval is great for patients if the drug is as safe and effective as hoped. But the post-market trials must be conducted without delay to ensure we aren’t being given false hope or being exposed to medications that could have harmful effects.”

Photo by Samuel Schroth on Unsplash