A recent study by Harvard and Stanford researchers seems to indicate that FDA approvals made closest to the review deadline have higher post-market safety problems. While no cause and effect is yet claimed, the researchers do note a positive association and suggest the deadlines link to funding may have unintended safety consequences.
PDUFA which links FDA funding to its ability to meet drug application review deadlines may be altering FDA review behavior. The study indicates that more reviews now pile up around the 6 month deadline than before PDUFA existed as legislation. Drugs reviewed and approved less than 2 months before the deadline is reached experience higher post-market safety issues than drugs approved more than 3 months before the deadline or after the deadline was reached. A new black box warning is 3.27 times more likely for a drug approved within the 2 month window, and safety related withdrawl is 6.92 times more likely for these drugs.
The study was published at a time when Congress is conducting PDUFA hearings looking at renewal of the legislation. How are we going to choose to balance risk and reward?
Posted by Bruce Lehr Feb 2nd 2012