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Full Text of this Amendment

SA 1062. Mr. DORGAN (for himself and Ms. Snowe) 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 in the amendment, insert the following:
SEC. __. CERTIFICATION OF SAFETY FOR NEW PRESCRIPTION DRUGS.
Notwithstanding any other provision of law, the Secretary of Health and Human Services shall certify, prior to the approval for marketing of any new prescription drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), that the approval of such drug poses no additional risk to the public's health and safety.


(As printed in the Congressional Record for the Senate on May 8, 2007.)