FDA Postmarket Studies Plagued by Widespread Delays

The FDA's reliance on postmarket studies to evaluate the safety and efficacy of approved drugs has led to widespread delays, according to an analysis by KFF Health News. The study found that hundreds of postmarket studies were behind schedule, with some dating back over a decade.

One such case is Tavneos, a drug used to treat rare autoimmune diseases. When the FDA approved it in 2021, it required Amgen to conduct an additional years-long safety study once the drug was on the market. However, as of last fall, only 21 of the planned 300 patients had been enrolled.

The FDA has identified dozens of cases of liver damage possibly or probably associated with Tavneos, a potential side effect the postmarket study was meant to evaluate. The agency's approach to relying on postmarket studies reflects a balancing act between making new treatments available quickly and ensuring their safety.

Cardiologist Sanket Dhruva has criticized the FDA's reliance on postmarket studies, saying they 'have often proven toothless.' Others argue that the delays are due to legitimate reasons such as challenges in enrolling patients or conducting trials.