[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 954 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                 S. 954

 To establish procedures regarding the approval of opioid drugs by the 
                     Food and Drug Administration.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 15, 2015

   Mr. Manchin (for himself, Mr. Vitter, Mrs. Capito, and Mr. Kaine) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To establish procedures regarding the approval of opioid drugs by the 
                     Food and Drug Administration.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Accountability for Public Safety 
Act''.

SEC. 2. APPROVAL OF OPIOID DRUGS.

    (a) In General.--Notwithstanding any other provision of law, the 
Commissioner of Food and Drugs (referred to in this Act 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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