Drug Amendments Act

[AI summary unavailable — showing source text] 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 attribute…