A bill to amend and supplement the Federal Food, Drug, and Cosmetic Act with respect to the manufacture and distribution of drugs, and for other purposes.
Drug Amendments Act of 1979 - Eliminates certain exceptions from the definition of the term "new drug" as used in the Federal Food, Drug, and Cosmetic Act. Provides that any drug which is a new drug as defined by such Act is subject to all requirements of such Act without regard to: (1) the dates upon which such drug was ever commercially used or sold in the United States; (2) whether or not a new drug application was in effect on or before October 9, 1962; (3) whether or not such drug was a new drug on or before October 9, 1962 as then defined by the Federal Food, Drug and Cosmetic Act; and (4) whether or not such drug is intended solely for use under the conditions prescribed, recommended, or suggested in labeling with respect to such drug prior to October 9, 1962.
Provides that labeling, advertising, or promotional material for an article is deemed to be misleading if the representation made or suggested by statement, word, design, device, or any combination thereof relate to, concern, or otherwise bear upon; (1) the safety or effectiveness of use of a drug or device, unless such representations are based upon adequate and well controlled investigations; and (2) any attributes, characteristics, or qualities of the article, or any matter relating thereto, unless such representations are based on data, upon which experts qualified in the evaluation of such data, could fairly and responsibly conclude that the representations made for the article in its labeling, advertising, or promotional material are fully supported.
States that no publisher, radio broadcast licensee, or agency medium for the dissemination of advertising or promotional material, except the manufacturer, packer, distributor, or seller of the article to which the the false advertisement related, shall be liable under this Act for the dissemination of any false advertisement or promotional material unless he has refused, after the request of the Secretary of Health, Education and Welfare, to furnish the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency residing in the United States who caused him to disseminate such advertisement or promotional material.
Removes the inspection restrictions, for purposes of enforcement of the Federal Food, Drug, and Cosmetic Act, of research data with respect to drugs.
Provides that the Secretary may require by subpoena the attendance and testimony of witnesses and the production of documentary evidence bearing on whether any food, drug, device or cosmetic is in violation of the Federal Food Drug and Cosmetic Act.
Introduced in Senate
Referred to Senate Committee on Labor and Human Resources.
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