When FDA reviewers cram, do they perform poorly on the test? A new study concludes that yes, when drugs are approved right on deadline, they're more likely to cause safety problems later. The Harvard analysis, published in this week's New England Journal of Medicine, concludes that drugs approved in the two months leading up to the deadline are four to five times more likely to be withdrawn or require serious safety warnings. Think Pfizer's rezulin, withdrawn on liver problems. Bayer's Baycol, taken off the market because of muscle damage. Or Vioxx, spiked for its increased risk of heart attack and stroke.
Drugs approved faster didn't have the same safety profile, and nor were meds whose approval missed the deadline.
Some background: When Congress OK'd user fees to allow FDA to hire more reviewers, it imposed a 12-month deadline on approvals; later that timeframe was shortened to 10 months. The idea was that drug companies might be forced to pay for review, but they should at least get quick service as a result. Critics have since suggested that the deadlines might cause the FDA to make hasty decisions.
The new study appears to bolster those concerns. But the FDA shot back quickly when its concussions were released, releasing its own stats that showed an increase in withdrawals among drugs OK'd on deadline, but not enough to be statistically significant. "FDA won't approve a drug if we are not ready," CDER chief Dr. Janet Woodcock (photo) told the Washington Post. But according to the Wall Street Journal, Woodcock also has said that the deadlines caused "a sweatshop atmosphere" at the agency, leading to staff turnover. (A spokesman said she wouldn't say the same thing today.) But more debate is sure to come.