A Good Proposal on Drug Safety

The U.S. Food and Drug Administration has 1,400 employees working to approve new drugs, but a scant 52 FDA employees monitor the safety of 5,000 drugs already in the pharmacies or available over the counter. Put those numbers together with the 100,000 yearly deaths due to adverse drug reactions and 1.5 million hospitalizations and it’s clear there’s something out of whack.

The Journal of the American Medical Assn. attacks this problem in its current issue, and proposes a reasonable, effective solution--a separate Office of Drug Safety, shielded from drug company pressure. A thorough monitoring program would cost about $24 million a year, one penny per prescription.

The change could come at little or no added cost to government if Congress were to fix a 1992 law called the Prescription Drug User Fee Act. Drug companies pay Washington “user fees” to help fund FDA oversight of their drugs, but they successfully lobbied Congress to prohibit use of the fees to track adverse reactions after approval. Not surprisingly, drug companies want resources devoted to getting their products to market. But Congress and the Clinton administration should not let the FDA be cowed into forgetting oversight of drugs once they have landed on shelves.

The FDA estimates that only 1% of adverse drug reactions are ever reported by doctors. Each year, for example, there are official reports of fewer than 100 adverse reactions to digoxin, a drug prescribed for heart problems. But a systematic study of Medicare records found 202,211 hospitalizations in a seven-year period for digoxin adverse reactions in the Medicare population alone.

So even as oversight is beefed up, says the the journal, doctors should be required to do better reporting of adverse reactions. This is all common sense. Problems with adverse drug reactions ought to be dealt with in the monitoring process, not just in emergency rooms.