Drug Amendments Act

Drug Amendments Act - Eliminates the exception for drugs under 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 the above 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 representations 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 are based, 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 or medium for the dissemination of advertising or promotional material, except the manufacturer, packer, distributor, or seller of the article to which the false advertisement related, shall be liable under this Act by reason of the dissemination by him of any false advertisement of promotional material unless he has refused, on 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.

Provides that whenever it appears to the satisfaction of the court in the case of a newspaper, magazine, periodical, or other publication published at regular intervals: (1) that restraining the dissemination of a false advertisement in any particular issue of such issue at the regular time therefor, and (2) that such delay would be due to the method by which the manufacture and distribution of such publication is customarily conducted by the publisher in accordance with sound business practice, and not to any method or device adopted for the evasion of the prohibition against false or misleading advertising or to prevent or delay the issuance of an injunction or restraining order with respect to such false advertisement; the court shall exclude such issue from the operation of a restraining order or injunction.

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 subpena 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.