The Carter administration has drafted a new drug regulation bill designed to get prescription medicines on the market more rapidly and remove dangerous ones faster.
Federal health officials started showing the draft to congressional health committees this week, and one administration official said, "I think we're 84 percent of the way there" on what the bill will finally say.
The far-reaching proposal, if enacted, would be the first major revision of federal prescription drug law since the Kefauver amendments of 1962 made drug firms start demonstrating their products' safety and effectiveness.
A copy of the proposal obtained by The Washington Post shows that the administration would now require drug firms to make public much of the information they collect about their drugs' safety and efficacy - and in many cases put summaries of that information in easy-to-read package inserts for patients.
But the bill would require drug makers to give the Food and Drug Administration all their raw data on a drug's development only if the FDA requests it. In other cases, they would only have to certify the summaries of their investigations as "true and accurate."
The raw data on animal and chemical tests has often given FDA doctors their first information on faulty or fraudulent testing, and any proposal to forgo it is sure to come under fire from drug firms' many critics.
Chairman Edward M. Kennedy (D-Mass.) of the Senate Health and Scientific Research Subcommittee, a leading advocate of drug law changes, yesterday called the administration draft "a constructive step in the development of reform in the nation's drug laws."
But he said he is not endorsing the administration proposal and has many questions about it. He told his subcommittee staff to give "highest priority" to working with Health, Education and Welfare officials ideas into a workable bill to be presented early next session.
Kennedy, Gaylord Nelson (D-Wis.), Harrison A. Williams Jr. (D-N.J.) and Jacob K. Javits (R-N.Y.) are all authors of bills to make drastic changes in the way the government regulates medicines.
Drug firms and many doctors say the United States is suffering from a serious "drug lag" caused by FDA requirements that often make them go through years of testing and paperwork before a drug is approved.
But consumer forces and many doctors say the United States should do still more to protect the public from possible harm.
The heart of the administration bill is a proposal to substitute the mere issuance of an official order, which the draft bill refers to as a "monograph" as the means of approving any new drug. The monograph would describe the drug and its purposes or limits, as well as the evidence by which the HEW Secretary has approved it.
If new evidence later developed - which is often the case as a drug is used in millions of patients - the secretary could issue a revised monograph at any time, or susupend or revoke the previous approval.
Today the legal process necessary to revoke approval of a drug often consumes two years or longer, only by declaring a drug an "imminent hazard," a concept difficult to prove, can the FDA move faster. Even this process can often take six months, as it did this year when - for the first time since in got this power in 1962 - the FDA used it to halt sales of the anti-diabetes drug Phenformin.
But where present law makes drug "safety" a rigid, almost absolute requirement, the new proposal would give it the kind of working definition doctors usually use."Safety," says the proposal, means a drug's risks are "acceptable in view of the expected benefits."
An HEW Secretary could even waive the usual requirement for "well-controlled clinical investigations" - tests on many patients, with suitable controls - in cases where the drug is needed and ordinary testing is impossible.
The secreatry could limit use of some powerful, easily abused drugs to specified facilities, such as hospitals, or require that a drug be given only to certain types of patients or patients who give informed consent to its use.
The proposal would require drug sellers to place the manufacturer's name on every package. Drug companies often hire other firms to make medicines for them, then sell them under their own name.
To speed up approval of new drugs, however, the secretary could encourage firms to join efforts in research - or join efforts after approval to give HEW regular reports on any ill effects.