FDA Drug Monitoring Falls Short

In 1997, President Clinton signed a law to speed the Food and Drug Administration’s approval of new prescription drugs. Under the new law, the average time for approval has dropped to 12 months from about 30 months. However, the FDA’s recall of eight prescription drugs since the law’s approval suggests that the agency may be short-shrifting safety in hurrying drugs to market.

A case in point was the FDA’s decision Tuesday to remove the adult-diabetes drug Rezulin from the market--more than two years after testing linked it to liver failure.

Tuesday night, Rezulin’s manufacturer, New Jersey-based Warner-Lambert Co., complained that the FDA had removed the drug merely because of “repeated media reports sensationalizing the risks associated with Rezulin therapy.” Much of that reporting, which was far from sensationalizing, came from The Times’ David Willman.

The FDA has linked the drug to 63 recorded deaths, a small proportion of the 1.9 million diabetics who have taken the drug. But consumer safety groups say the figure is probably much higher, and the FDA’s senior epidemiologist reportedly estimates that 20 Rezulin patients a month have been suffering liver failure.

The dispute over the extent of Rezulin’s harm underscores the inability of the FDA’s “post-market surveillance” system to gauge the dangers of prescription drugs. One key problem is the FDA’s concentration on drug approval at the expense of monitoring. Another is the agency’s failure to require doctors and hospitals to report instances when they suspect that a drug has seriously harmed a patient.

Congress, now meeting with FDA officials to decide on the agency’s budget for fiscal 2001, has a perfect opportunity to beef up post-market surveillance and reporting of serious adverse drug reactions. Legislators should also press the FDA about why it failed to require liver testing in Rezulin users upon the drug’s release in 1997, even though Warner-Lambert’s own tests suggested that the drug caused liver damage?

Congress and the Clinton administration may have been right in 1997 to allow some drugs on a fast track to approval. But Rezulin’s story suggests that in doing so they may have put continued drug safety monitoring on a dangerously slow track.