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Full Text of this Amendment

SA 995. Mr. GRASSLEY 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 end of subtitle E of title II, insert the following:
SEC. 2X. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY; CHIEF SAFETY OFFICER.
(a) Authority.--With respect to all actions of the Food and Drug Administration related to postmarketing drug safety, including labeling changes, postapproval studies, and restrictions on distribution or use of drugs with serious risks, the Office of Surveillance and Epidemiology (or successor office) of such Administration and the Office of New Drugs (or successor office) of such Administration shall make decisions jointly. In the event of a disagreement with respect to an action related
to postmarketing drug safety, including labeling changes, postapproval studies, and restrictions on distribution or use of drugs with serious risks, between such 2 offices, the Commissioner of Food and Drugs shall make the decision with respect to such action.
(b) Chief Safety Officer.--Notwithstanding any other provision of law, the Director of the Office of Surveillance and Epidemiology (or successor office) of the Food and Drug Administration shall serve as the Chief Postmarket Drug Safety Officer within the Food and Drug Administration. In such capacity, the Director shall serve as a liaison between the Office of the Commissioner of Food and Drugs and employees of the Food and Drug Administration. To ensure drug safety concerns are identified
and promptly evaluated and resolved, any employee of the Center for Drug Evaluation and Research within the Food and Drug Administration who has drug safety concerns may report such concerns to the Chief Postmarket Drug Safety Officer.


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