More than 10 years after a Food and Drug Administration committee introduced the concept of informed consent for approved drugs, the agency's officials still don't know if their strategies for issuing drug warnings are working.
And critics say the FDA's uncertainty is just one more symptom of an entire system in shambles.
"The recommendations are out there, and the FDA can point to them on paper," said Bruce Psaty, an associate professor of medicine at the University of Washington. "But what's the evidence that they work?"
On April 26, 1988, the FDA's Dermatologic Drugs Advisory Committee tried a new response to some troubling news. The drug isotretinoin, widely prescribed as Accutane for severe acne, had been blamed for at least 62 cases of serious birth defects.
Among other recommendations, the committee decided that patients should sign an informed consent form to ensure that they understood the risks before receiving the drug.
In June, the FDA unveiled its newest tactic. For a handful of drugs every year, pharmacists will distribute Medication Guides directly to patients to inform them of the drugs' potential dangers.
Although Medication Guides have not yet been distributed, FDA officials contacted by Newsday were at a loss to say whether anyone is heeding older tactics such as informed consent, "Dear Doctor" letters from drug manufacturers and beefed-up patient information.
"Most of the time, to be perfectly honest, we haven't made a systematic attempt to try to learn that information," said Russell Katz, acting director of the FDA's Division of Neuropharmacological Drug Products.
Dr. Robert Temple, the associate director for medical policy at the FDA's Center for Drug Evaluation and Research, said the agency is committed to informing the public about potentially dangerous drugs.
"It's not hard to figure out that you have to tell patients about particular drug risks," he said. "How best to do that is another question."
The answer may not come until 2002, when the FDA plans to reassess overall risk communication strategy.
Pub Date: 9/22/99