Congress Clears Measure To Speed Drugs to Market
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Congress tonight approved a new charter for the Food and Drug Administration that will speed the approval of prescription drugs. Negotiators from the House and the Senate also said they had agreed on sweeping changes in child-adoption policy. President Clinton is expected to sign both bills. The F.D.A. measure, a product of three years’ work on Capitol Hill, was approved by voice vote in the Senate and then in the House. On Saturday, the Senate also confirmed Mr. Clinton’s nominees to run the Medicare, Medicaid and welfare programs. The votes came in a last-minute burst of activity as lawmakers rushed to end the first session of the 105th Congress. The F.D.A. bill was a bipartisan compromise, achieved after Republicans scaled back many of their initial proposals to loosen Federal regulation of drugs and medical devices. Earlier proposals would have set deadlines for F.D.A. action, with marketing of certain new drugs automatically allowed if the agency did not meet the deadlines. Senator Edward M. Kennedy, Democrat of Massachusetts, led the opposition to many of the original Republican proposals. He hailed the final agreement tonight as ”a victory for public health, for patients and for industry alike.” Mr. Kennedy beat back several proposals that he saw as weakening the authority of the F.D.A. to regulate medical devices. Senator James M. Jeffords, the Vermont Republican who is chairman of the Committee on Labor and Human Resources, said the bill made the most significant changes in drug regulation in three decades. Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, a trade association for drug companies, welcomed the final agreement. In an interview, he said that the bill would shave at least one year off the average time that elapses from the discovery of a new drug in the laboratory to its arrival in the family medicine chest. The average time is now 12 to 15 years, Mr. Holmer said. More : query.nytimes.com |