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Full Text of this Amendment

SA 989. Mr. HARKIN submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:
SEC. __. REQUIRED INFORMATION IN DIRECT-TO-CONSUMER TELEVISION AND RADIO ADVERTISEMENTS.
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting after the first sentence the following: ``In addition to the requirements under the preceding sentence, in the case of an advertisement of a prescription drug presented directly to consumers in television or radio format that states the name of the drug and its medical indications, unless the audio portion of such advertisement includes a listing of all information in full about adverse reactions,
contraindications, and precautions listed in the patient or professional labeling of the drug approved under this Act.''.


(As printed in the Congressional Record for the Senate on May 1, 2007.)