The Carter administration asked Congress Yesterday to enact the first major revision of the nation's drug laws in 40 years, expanding the Food and Drug Administration's powers while attempting to reduce the time it takes to make new drugs available to those whom they are intended to benefit.
The legislation also contains a number of measures aimed at reducing the price of drugs, increasing the information available to consumers about the risks and dangers of drugs and putting restrictions on the way drug firms market their products.
Health, Education and Welfare Secretary Joseph A. Califano Jr. described the bill as a "vast new piece of legislation . . . unquestionably the most important piece of legislation in the health field to be sent up in many years."
Califano, giving a major portion of the credit for the proposal to senators and representatives concerned with health issues, said the bill is the product of 10 years of hearings and discussions. Despite that lengthy gestation period and an attempt by the administration to achieve a consensus among all parties, the bill already was stirring controversy before being introduced.
C. Joseph Stetler, president of the Pharmaceutical Manufacturers Association, said drug manufacturers support new legislation in principle. However, he said, "We cannot support this bill because of some major problems it will create for our industry." Stetler said that the bill gives too much discretionary authority to HEW and that rather than cutting the time it takes for new drugs to become available, it may increase it.
At the same time, consumer advocates have charged that some of the bill's provisions are not needed and will compromise the safety of the public in order to speed approval.
Califano was able to produce a number of legislators - Republicans and Democrats - as co-sponsors, but at one point this week support for the legislation almost collapsed when the Office of Management and Budget balked at the creation of a National Center for Clinical Pharmacology.
The proposed center, strongly backed by Sen. Edward M. Kennedy (D-Mass.), would be authorized to help medical schools educate their students about drugs, help educate other medical personnel about drugs, produce an annual drug experience assessment, develop new drugs of limited commercial value, indicate areas where research ought to be conducted and study long-range drug policies.
Kennedy was on hand yesterday to endorse the legislation, which he said would help remedy "gaps" in an "anachronistic system."
The current drug law, the Food, Drug and Cosmetic Act, was passed in 1938 and received substantial amendments in 1962. The proposal being sent to Congress would be the first total rewrite of the measure since 1938.
Among the bill's provisions are:
Changes that would allow "breakthrough drugs" - those that appear to be a major advance in the treatment of life-threatening or debilitating ailments - to be given quicker, conditional approval. Such approval could be granted only if there were significant evidence of effectiveness and safety, and would be followed by continued checking.
Quick removal of drugs by changing the law's present standards from "imminent hazard" to public health to "unreasonable and substantial risk of illness and injury" and by setting deadlines for hearings within 90 days after the FDA proposes removal. In cases where the danger is judged great enough, the drug could be removed prior to a hearing.
Empowering the FDA to require drug companies to collect data on the use and effectiveness of drugs after they have been approved for marketing.
Changing the approval process by allowing drug companies to present research proposals in two steps - an "innovative" phase for which information only on safety to human subjects need be presented, and a "developmental" phase for which a more detailed research plan would be required.
Releasing data on the safety and effectiveness of a drug, a move Califano said would help "open the doors in this country to medical decisions." Drug companies charge that release of the data will hurt their competitive position and will encourage them to register new drugs abroad before they are registered here to prevent pirating of their research data by other companies.
Banning the giving of free samples by drug company "detail" men, banning gifts to physicians, nurses and medical students from drug companies of more than $5 value, requiring the generic as well as the brand name to be used on a drug and requiring clear warnings in all advertising about possible risks and harmful side effects.