Drug Regulation Reform Act of 1979

Summary

Drug Regulation Reform Act of 1979 - Title I: Amendments to Federal Food, Drug, and Cosmetic Act - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "person" subject to the coverage of the Act to include an agency of government. Establishes civil penalties for any violation of such Act and criminal penalties for negligent commission of prohibited acts. Requires any new drug to meet standards of identity, stability, and bioavailability, as well as of strength, quality, and purity. Requires drug manufacturers and distributors to prepare information labeling for patients containing: (1) a summary of the benefits and risks of use of a drug; (2) adequate directions for use; and (3) information about proper storage and handling. Requires pharmacies to keep a book available to patients containing the labeling information for the 100 most frequently sold prescription drugs. Authorizes the Secretary of Health, Education,and Welfare to require retail drug sellers to post the retail prices of designated prescription drugs. Requires manufacturers and distributors to prepare information labeling for practitioners regarding indications, contraindications, and other pertinent matters. Directs the Secretary to afford private organizations the opportunity to prepare, publish, and distribute an index of all prescription drugs and revisions thereof; and if, at the end of three years following enactment, no private index is forthcoming, to prepare one with drugs arranged by diagnostic and therapeutic categories and listed by established name. Permits the Secretary, by order, to require adequate notification to patients, practitioners, and all other necessary persons regarding any substantial risk of illness or injury posed by a drug, if such notification is an effective means to eliminate or reduce such risk. Authorizes the Secretary to disseminate information regarding the safety, effectiveness, and proper use of drugs, and to determine therapeutically equivalent or nonequivalent prescription drugs. Specifies requirements for any promotion labeling issued by or on behalf of a drug manufacturer or any other person under whose proprietary name the drug is distributed. Prohibits the provision of any services or transfer of any property worth more than $5.00 by a manufacturer or distributor with the intent to influence any specified person to buy, prescribe, or dispense one or more particular drugs. Prohibits the distribution of free samples by a manufacturer or distributor, except in specified circumstances. Prohibits any pharmacist or agent from disclosing any prescription information to any person except the patient, the practitioner, another pharmacist for purposes of filling or refilling it, or a State or Federal officer or employee under certain circumstances. Prohibits manufacturers and distributors from obtaining or attempting to obtain prescription information. Changes the ground for immediate suspension of approval of a drug application from "imminent hazard to the public health" to "unreasonable risk of illness or injury to any segment of the population." Requires clinical investigators to obtain voluntary informed consent, in writing, of all human beings, or their representatives, to whom a drug is administered in order to investigate the benefits and risks of such drug. Directs the Secretary to issue written, non-mandatory guidelines regarding protocols and methods for conducting drug investigations. Specifies factors of the health benefits versus risks analysis required for the determination of the safety of a drug. Requires the Secretary to approve the application for a drug proven safe but not proven effective if it is to be prescribed to treat a life-threatening or severely debilitating condition, there is no other effective method of treatment, and there is significant, if not substantial, scientific evidence that such drug is effective. Eliminates existing specified requirements for the certification of drugs containing insulin and antibiotic drugs. Allows the Secretary discretion to impose specified additional requirements as a condition for approval of any drug application. Authorizes the appointment of advisory committees to assist in making the determinations authorized by such Act. Authorizes the Secretary to subpoena witnesses and records in any matter relating to implementation or enforcement of such Act. Allows the manufacture for export, or export of, a drug without an export permit if it is manufactured, packaged, labeled, and distributed in compliance with specified requirements. Title II: National Center for Drug Science - Amends the Public Health Service Act to establish in the Department of Health, Education, and Welfare the National Center for Drug Science, with a Division of Policy and Research and a Division of Clinical Pharmacology and Clinical Pharmacy Training. Directs the Center to conduct an ongoing program of drug science policy research, either directly or by grant or contract, and an ongoing review and analysis of drug use in the United States which shall result in an annual Drug Experience Assessment Report. Directs the Director of the Center to make grants to schools of medicine, osteopathy, dentistry, pharmacy, podiatry, nursing and training centers for allied health professions for the expansion of existing programs and the establishment of new programs. Authorizes appropriations for demonstration projects, traineeships, and fellowships. Establishes a National Advisory Board on Drug Science to assist the Director and to review and comment on the activities of the Center. Title III: Establishment of the Food and Drug Administration - Establishes within the Department of Health, Education, and Welfare the Food and Drug Administration. Transfers to the Administration specified functions under specified Acts.

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Documents

3 official files

• Passed Senate amended

  summary · EN · 26 September 1979

  Open at official source

• Reported to Senate with amendment(s)

  summary · EN · 18 September 1979

  Open at official source

• Introduced in Senate

  summary · EN · 3 May 1979

  Open at official source

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