Are FDA deadlines behind marketplace safety issues?
Authors of the study concluded that drugs approved in the two months before the deadline are more likely to end up with marketplace safety problems than those that are approved earlier in the process.
Since 1993, 97 drugs have been approved in the two-month window, and 14% of them have gone on to show serious safety problems, compared with 3% for 216 other drugs approved during that time, the study said.
The authors of the study are based at Harvard Medical School's department of government. They describe the last two months as the period “immediately before the deadline.” Deadlines are part of the PDUFA program where drug makers fund the FDA and the agency is obliged to meet tight deadlines for decisions.
The authors wrote that their findings “suggest potential adverse effects of the deadlines governing FDA drug review.” They added that higher levels of staffing and less adherence to strict deadlines might allow the agency to review applications quickly without compromising safety.
For an abstract of the NEJM article, click here.