September 8, 2005

Faster drug approvals haven't led to more safety-related drug withdrawals, says a study by the Tufts Center for the Study of Drug Development (CSDD), even as critics decry the FDA for not protecting consumers in the wake of the Vioxx scandal.

Safety-related drug withdrawals have accounted for just 1.6 percent of product recalls since 2000, compared to 3.2 percent in the 1980s, according to the recently released study.

The report is part of an ongoing CSDD investigation into whether a 1992 law requiring drugmakers to pick up part of the cost for drug application reviews has weakened U.S. drug-safety standards. The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from drugmakers to expedite the drug review process.

Spurred by revelations such as how the FDA didn't reveal cardiovascular risks associated with Merck's withdrawn arthritis pain drug Vioxx (rofecoxib), critics say the agency isn't doing enough to ensure approved drugs are safe.

The CSDD study found not only that drug withdrawals decreased, but also that nearly half of the drugs recalled for safety reasons between 1980 and 2005 were approved before drug companies started to pay user fees in 1993. Moreover, drugs with safety issues are now being taken off the market more quickly, with the length of time between a drug's approval and withdrawal falling from 3.7 years in the 1980s to 0.7 years since 2000.

Researchers also found no trend between approval speed and safety withdrawals within drug classes. Withdrawn drugs in some classes had slightly shorter approval times than all approved drugs in those classes, whereas others had the same or slightly longer approval times.

Additionally, longer approval times don't necessarily lead to better drug safety, the report shows. Drugs withdrawn since 1980 took an average of 2.14 years to gain approval, compared to an overall average approval time of 2.08 years for all drugs approved since 1980, the report states.