A bill to amend the Federal Food, Drug, and Cosmetic Act to require the generic labeling of drugs and the disclosure to drug users of side effects, adverse reactions, and related information; to strengthen the records and reports authority under that act; to require the reporting of information respecting significant health hazards to authorize conditional approval of new drugs; to strengthen the Food and Drug Administration.

Summary

Title I: Drug Safety Amendments - Drug Safety Amendments - Requires, under the Federal Food, Drug, and Cosmetic Act, the insertion on packages of any drug which may be sold only upon prescription, the name and place of business of the manufacturer of the final dosage form of the drug and, if different, the name and place of business of the packer or distributor and, in the case of any other drug or device, the name and place of business of the manufacturer, packer, or distributor. Requires reports on, and record-keeping pertaining to, clinical and preclinical investigation of drugs or substances intended for use as a drug. Provides that if the Secretary of Health, Education, and Welfare determines that any information obtained or received by him reasonably supports a conclusion that such a drug introduced for commercial distribution may present a significant hazard to human health, or may cause cancer in animals, he shall mail or cause to be mailed to all practitioners licensed by law to administer drugs, a summary of such information. Provides for the conditional approval of new drugs by the Secretary. Authorizes the Secretary to immediately suspend approval of a drug application upon the finding that a condition has not been met. Authorizes the Secretary, acting through the National Institutes of Health and in consultation with the Commissioner of the Food and Drug Administration, to support studies of the short-term or long-term use of any drug and of drugs with alternative forms of therapy and studies involving the comparison of drugs. Authorizes the appropriation of $10,000,000 for each fiscal year for such studies. Requires the Secretary to make an annual report to the Congress respecting the activities undertaken or supported under this title. Title II: Food and Drug Administration - Food and Drug Administration Act - Establishes a Food and Drug Administration within the Department of Health, Education, and Welfare. Directs the President to appoint, with the advice and consent of the Senate, a Commissioner of the Administration. Directs the Commissioner to: (1) attempt to eliminate products presenting unreasonable risk of disease, injury, or death; (2) establish a capability within the Commission to engage in risk-based analysis; (3) establish an interdisciplinary epidemiology capability and undertake investigations to facilitate regulation-making and to assist in risk-based analysis; (4) establish a scientific capability within the Administration to assist in hazard detection, test method development, and quality control requirements; and (5) utilize field operations to conduct product evaluation, facilitate detection of conditions associated with products subject to his jurisdiction which might lead to disease, injury, or death, to monitor compliance with required levels of safety performance, to report violations, and to assist in enforcement actions.

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• Introduced in House

  summary · EN · 29 January 1976

  Open at official source

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