Drug Brakes

Is a slow FDA a safe FDA?

Ever since Congress helped speed up the Food and Drug Administration’s rate of drug approvals in 1992, critics have complained that the relatively quick approval times put patients in danger. So when Merck’s Vioxx was shown to cause heart attacks in 2004, a chastened agency slowed the process considerably. In September The New York Times reported that the 2005 approval rate was the slowest in a decade.

So what’s the correlation between approval times and drug safety? According to a 2005 report by the Tufts University Center for the Study of Drug Development, there isn’t one.

Researchers say the percentage of drugs withdrawn for safety reasons was 3.2 percent in the 1980s, rose slightly in the ’90s to 3.5 percent, and fell in the new century to 1.6 percent. And approval time for drugs that are later withdrawn for safety reasons is not appreciably shorter than the average approval times for all drugs.

The good news is that the dangerous drugs are withdrawn from the market much sooner than used to be the case. The average time between government approval and subsequent safety withdrawal has dropped from 3.7 years in the 1980s to just 0.7 years today.