The Food and Drug Administration yesterday proposed to combat wide overuse and misuse of prescription drugs by requiring a pamphlet describing proper uses, dangers and side effects in every drug package.
Among the first drugs affected, FDA officials said, will be commonly used tranquilizers like Valium, which can cause drug dependency, and potent antibiotics, which may have ill effects patients should watch for.
Also, said Dr. Louis Morris, chief of FDA's patient labeling section, "We want to insure compliance with doctor's directions. A patient may stop taking an antibiotic because he feels better. But unless the drug is taken for a full course, as for 10 days, there may be a relapse,"
Some pamphlets may be ready for use "in a year and a half or two years," Morris said. Some other FDA officials said it might take five years before there are pamplets for most drugs.
For this reason, and because FDA's proposal came years after consumer and women's groups first urged it, one public interest lawyer called the move a disappointment.
"This has been widely discussed, and FDA has admitted the need for it for well over five years," said Marcia Greenberger of the Center for Law and Social Policy here. In early 1975, on behalf of several groups, including the National Organization for Women, the public interest law firm petitioned the FDA to urge such pamphlets.
"FDA has moved at a snail's pace," Greenberger said, "and it could be years more before there's a real program."
FDA could be forced to move more quickly by a drug regulation revision bill approved by the Senate Human Relations Committee last week. Its health subcommittee chairman, Edward M. Kennedy (D-Mass.), is expected to seek early floor action, and some House members have said they will seek progress there.
Passage could be hampered by the fact that FDA Commissioner Donald Kennedy left FDA yesterday to return to Stanford University. Many members of Congress may want to hear his successor's views on any bill.
Donald Kennedy said yesterday that FDA expects to implement the new proposal some time after a 90-day public comment and hearing period.
"Patients should have more information about prescription drugs," he said. "I hope the PPIs" - the patient package inserts, as the pamphlets are to be called - "will help stimulate discussions between doctors and patients" and reinforce information provided by doctors.
FDA already requires patients package inserts for some products, including intra-uterine devices (IUDs), hearing aids and a few drugs, mainly hormones such as birth control pills, estrogens for menopausal women and progestins.
Now FDA will publish a list of 90 drugs in the Federal Register and ask for comment on which should have priority. It will then develop the possible wording of pamphlets for an initial 50 to 75 drugs, then, drug by drug, require manufacturers to develop and print the final pamphlets, providing equally full informations.
After five years, perhaps, said one official, pamphlets might exist for 375 basic drugs, or 90 percent of those on the market.
The Pharmaceutical Manufacturers Association has supported the idea of more information for patients. But it has gone to court to question FDA's authority to issue the regulations governing the pamphlets for estrogen drugs, such as Premarin, which cause an excess incidence of cancer in women who take them after menopause.
"Some drug companies are putting in some patient package inserts voluntarily," FDA's Morris added. "The pharmaceutical industry isn't monolithic, and some companies want to try them and see what happens."