Government
Drug law relorms proliferate in congress Some old and some new bills have been introduced to speed introduction of new drugs and to settle problem of safety test data disclosure
A number of new and not-so-new proposals to reform the U.S. prescription drug laws have surfaced in Congress. The Carter Administration has resurrected its bill, S. 1045, which is sponsored, as a courtesy to the Administration, by Senate Health Subcommittee chairman Edward M. Kennedy (D,-Mass.). However, Kennedy has introduced his own competing proposal (S. 1075) that is substantially different from the Administration's bill. Most pharmaceutical companies find the Kennedy bill more agreeable than the Administration measure. Yet another drug law revision bill (S. 1138) has been introduced by the Senate Health Subcommittee's ranking minority member, Pennsylvania Republican Richard Schweiker. It, too, contains many agreeable provisions as far as drug makers are concerned and has the potential for being blended with the Kennedy measure. The Administration bill doesn't have much chance in the 96th Congress, given the competing proposals by chairman Kennedy and Schweiker. It also doesn't have much chance because of determined industry opposition, which helped torpedo it last year. Notes Pharmaceutical Manufacturers Association president C. Joseph Stetler, "We felt along with others that the Administration's bill of last year was seriously flawed. Since S. 1045 is almost identical, we have the same reservations." PMA likes S. 1075 a lot better. A major goal of all the proposed drug law revisions is to speed the introduction of useful new drugs while ensuring that dangerous drugs can be quickly eliminated from the market. Most of the proposals would accomplish this by lowering the regulatory hurdles in the early phases of clinical 22
C&EN June 4, 1979
Senators Schweiker (left) and Kennedy have introduced competing drug bills
or human testing of new drugs, but would also make it easier for the government to remove already approved drugs from the market. One way to lower the hurdles, as provided by the Kennedy bill, would be to encourage drug companies to seek opinions of the Food & Drug Administration about the firm's plans and methods for testing new drugs, and the acceptability of test results. The bill would require FDA to render such advice. FDA also would be required to spell out in advance drugtesting guidelines for firms to follow. FDA would have to abide by the guidelines, too. A mechanism for resolving scientific disputes between FDA and drug firms also is provided. The Kennedy bill (along with Schweiker's) has eliminated a feature from last year's efforts that was odious to the pharmaceutical industry: full disclosure of safety and efficacy data developed in support of FDA approval. (The Administration bill still contains this provision, a sure kiss of death as far as the industry is concerned.) The drug industry is naturally horrified that data that it now jealously cherishes as trade secret would be made public. PMA has argued forcefully that publication of such data would be nothing but a gift to foreign competitors who could use it to short-cut drug development and beat U.S. companies to world markets. But advocates such as Marcia D. Greenberger of the Center for Law & Social Policy, a public interest law firm, see something ominous in releasing only summaries of research
data as the Kennedy bill provides. "The possibility of public scrutiny of raw data provides an important incentive to drug companies to assure that their testing is done honestly," she says. Among a host of other provisions, Kennedy's bill for the first time would establish FDA as a legal entity. Currently, the agency is simply an administrative extension of its parent, the Department of Health, Education & Welfare. The bill also would legally establish the position and authority of the FDA Commissioner, who would have to be nominated by the President and then confirmed by the Senate. As it now stands, the FDA Commissioner is a political appointee. The need for drug law reform, Kennedy told hearings of the Health Subcommittee last month, is not a trivial part of the U.S. health care effort. "No health issue has been as exhaustively studied, has a more complete legislative history, or is more important to the health of the American people than this one. The foundation has been laid." Nevertheless, the prospects for passage of any sort of drug law reform bill this year are not good. For one thing, the drug industry will continue to use its considerable lobbying muscle to thwart provisions that it finds objectionable, and many still are. For another, action on the House side is less than certain. Hearings on the proposals have not yet been scheduled and may not be until fall, if then. Chris Murray, C&EN Washington
