The Food and Drug Administration yesterday proposed scrapping its plan to require drug companies and pharmacists to provide informational leaflets with 10 widely used prescription drugs.
If the proposal becomes final after a 60-day comment period, it would complete the FDA's U-turn on the issue of how much information patients should have about their drugs and how they should get it. Consumer organizations have sought mandatory brochures for hundreds of drugs; doctors and pharmacists' have argued for voluntary programs.
With yesterday's announcement, the Reagan administration abandoned the mandatory policy almost completely. Health and Human Services Secretary Richard S. Schweiker and FDA Commissioner Arthur Hull Hayes Jr. said that the Carter administration's three-year pilot program for 10 drugs had "significant limitations and would impose unreasonable constraints on the health care system."
Instead Schweiker and Hayes announced the formation of a Committee on Patient Education within FDA to "provide a focal point for the activities of the FDA and other government agencies active in educating consumers about prescription drugs."
Yesterday's announcement was greeted with quick praise from the American Pharmaceutical Manufacturers Association and a chorus of denunciations by consumers groups and Dr. Jere Goyan, Hayes' predecessor and the architect of the pilot program. Among the 10 drugs that would have been covered are the painkiller Darvon and the tranquillizer Valium (the most widely prescribed drug in the country).
The pilot program was a scaled-down version of a 1977 proposal to require brochures for 375 drugs. But even the pilot program was strongly opposed by pharmacists, who argued it could cost them millions in extra labor and returned prescriptions. Some doctors argued that the leaflets--which would have included information about a drug's desired effects and potential side effects --could dissuade patients from taking prescribed medication.
The pilot program, which was set to begin in May, was put on hold shortly after the new administration took office. Sidney Wolfe, head of the Health Research Group, then led a suit to force the FDA to put the pilot program into effect.
"This administration seems to specialize in using new terminology for old ideas," said Goyan. "In the same way supply-side has replaced trickle-down in economics , 'freedom of choice' is another word for 'caveat emptor.' "
Yesterday's action has no effect on the requirements for informational inserts with prescriptions of birth-control pills, synthetic progesterone and menopausal estrogens.