[Congressional Record Volume 162, Number 32 (Monday, February 29, 2016)]
[Senate]
[Page S1097]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 3343. Mr. MANCHIN submitted an amendment intended to be proposed 
by him to the bill S. 524, to authorize the Attorney General to award 
grants to address the national epidemics of prescription opioid abuse 
and heroin use; which was ordered to lie on the table; as follows:

       At the end, add the following:

     SEC. 705. APPROVAL OF OPIOID DRUGS.

       (a) In General.--Notwithstanding any other provision of 
     law, the Commissioner of Food and Drugs (referred to in this 
     section as ``the Commissioner'') shall ensure that, with 
     respect to each application for an opioid drug submitted 
     under section 505 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355)--
       (1) an advisory committee of the Center for Drug Evaluation 
     and Research of the Food and Drug Administration evaluates 
     the application and issues a recommendation regarding 
     approval of such drug prior to a final decision to approve 
     such drug; and
       (2) if a final decision to approve such drug is 
     inconsistent with the recommendation under paragraph (1), 
     such final decision shall be made by the Commissioner and 
     shall not be delegated.
       (b) Reports to Congress.--If the advisory committee 
     recommends under subsection (a)(1) that the Commissioner not 
     approve an opioid drug under section 505 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355), and the Commissioner 
     approves that drug under subsection (a)(2), the Commissioner 
     shall--
       (1) submit a report to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives, and to any 
     member of Congress that requests the report, that includes--
       (A) medical and scientific evidence regarding patient 
     safety that clearly supports the Commissioner's decision to 
     approve the opioid drug against the recommendation of the 
     advisory committee; and
       (B) a disclosure of any potential conflicts of interest 
     that may exist regarding any official of the Food and Drug 
     Administration who was involved in the decision to approve 
     the drug prior to the Commissioner's final decision under 
     subsection (a)(2); and
       (2) at the request of the Committee on Health, Education, 
     Labor, and Pensions of the Senate or the Committee on Energy 
     and Commerce of the House of Representatives, testify before 
     that committee regarding the Commissioner's decision to 
     approve the opioid drug against the recommendation of the 
     advisory committee.
       (c) Prohibition on Marketing.--A drug described in 
     subsection (b) shall not be introduced or delivered for 
     introduction into interstate commerce until the report 
     described in subsection (b)(1) has been submitted to 
     Congress.
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