FDA Deadlines May Affect Drug Safety

Scott Kappes

Contributor
(866) 735-1102 Ext 346

0 CommentsPrint ArticleSubscribe

According to a study published in the New England Journal of Medicine deadlines for response to new drug applications may be causing the agency to make hasty decisions. The study suggests that drugs approved closer to the deadline end up having more safety issues once on the market than drugs that are approved earlier in the process. The study shows that of the 97 drugs that were approved within two months of the deadline since 1993, 14 percent went on to be associated with serious safety problems. Of the 216 other drugs that were approved earlier in the 10-month approval window only 3 percent ended up being associated with serious safety problems.

The deadlines are part of what's known as PDUFA, a program where drug makers fund the agency and the agency is obliged to meet tight deadlines for decisions in most cases. The authors write that their findings "suggest potential adverse effects of the deadlines governing FDA drug review," and say higher levels of staffing and less adherence to strict deadlines might allow the agency to review applications quickly without compromising safety.

The FDA says that their database does not support the article. The FDA is sending a detailed letter to the NEJM disputing the results of the Harvard based study.