National Drug Testing and Evaluation Act of 1979

Summary

National Drug Testing and Evaluation Act of 1979 - Establishes a National Drug Testing and Evaluation Center which shall be operated and maintained as a part of the Food and Drug Administration subject to the supervision and control of the Secretary of Health, Education, and Welfare. Provides that the Secretary of Health, Education, and Welfare shall be responsible for conducting all tests for investigations on new drugs submitted to him for approval in order to determine whether such new drugs should be approved for commercial distribution, and shall be responsible for conducting tests or investigations on drugs which have been approved to determine whether or not approval of such drugs should be withdrawn. Authorizes the Secretary to contract out such studies to qualified individuals, organizations, or institutions and makes it his responsibility to insure that the testing or investigation of any drug is conducted by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Directs that the sponsor of any drug submitted to the Secretary for testing and investigation, upon request, be provided with a report every 60 days on the results of the testing or investigation. Establishes a three-member drugs testing review panel to review, upon request of the sponsor, any facet of the investigation to which the sponsor objects. Provides that the sponsor of any new drugs submitted to the Secretary for testing or investigation shall be liable for the expenses incurred, including a appropriate share of the cost of staffing, maintaining and equipping the Center. Establishes a National Drug Testing Evaluation Center Fund which shall be available to the Secretary for the purpose of establishing the National Drug Testing Evaluation Center, for the purpose of furnishing initial working capital, and for other specified purposes. States that nothing in this Act prohibits the sponsor of any drug from conducting tests or investigations on such drug in accordance with other provisions of the Food and Drug Act.

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1 official file

• Introduced in Senate

  summary · EN · 27 March 1979

  Open at official source

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