Tight FDA deadlines enhance drug safety concerns

According to New England Journal of Medicine, manufacturing revisions and forced label changes are also more common in drugs that get faster-than-normal approval by the FDA. The authors blamed the federal law requiring the FDA to complete a certain proportion of licence applications within 12 months for the increasing number of fast-track approvals.

Under the controversial Prescription Drug User Fee Act (PDUFA) of 1992, the FDA must act on 90% of all drug candidates within 12 months of submission or face funding cuts. The time-line was even reduced to 10 months as part of the 1997 Food and Drug Administration Modernization Act. The restricted time frame gradually led to rushed approval of medications immediately before deadlines.

The study also found that drugs rushed to approval just before the deadline were two to three times more likely to eventually be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings known as ‘black box revisions’ and twice as likely to experience changes in manufacture. In addition, fast-tracked products were between two to seven times more likely to be voluntarily discontinued by manufacturers due to lack of clinical demand.

Daniel Carpenter, study investigator, said: “While we are not arguing that these deadlines should be abandoned, our research indicates that mechanisms other than strict deadlines may better balance the need for expeditious yet rigorous drug approval.”