Title: FDA Accountability for Public Safety Act
Policy area: Health

Summary:
FDA Accountability for Public Safety Act
Under the bill, a Food and Drug Administration (FDA) advisory committee must make recommendations regarding supplemental applications for opioids. Current law requires only that an FDA committee make recommendations on new drug applications.
The bill specifies that only the Commissioner of Food and Drugs may approve an opioid-related application against the recommendation of the committee. If the Commissioner approves such an application against a committee recommendation, the Commissioner must submit a report to Congress that includes (1) the evidence regarding patient safety that supports the Commissioner's decision, and (2) a disclosure of any potential conflicts of interest of FDA officials involved in the decision. The Commissioner must also testify before Congress regarding the decision, upon request. The drug in question may not be sold until the Commissioner has submitted the required report.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 418 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                 S. 418

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 7, 2019

  Mr. Manchin (for himself, Mrs. Capito, and Mr. King) 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 AGAINST THE RECOMMENDATION OF THE FDA ADVISORY 
              COMMITTEE ON OPIOID DRUGS.

    (a) In General.--Any approval of an application or supplement to an 
application under section 505(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)) for a drug that is an opioid against 
the recommendation of the advisory committee pursuant to section 106 of 
the Comprehensive Drug and Recovery Act of 2016 (Public Law 114-198) 
shall be made by the Commissioner of Food and Drugs (referred to in 
this section as the ``Commissioner'') and shall not be delegated.
    (b) Reports to Congress.--If the Commissioner approves a drug as 
described in subsection (a), 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); 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 approved as described in 
subsection (a) shall not be introduced or delivered for introduction 
into interstate commerce until the report described in subsection 
(b)(1) has been submitted to Congress.
    (d) Scope of Advisory Committee Review.--Section 106(a)(1)(A) of 
the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114-
198) is amended--
            (1) by inserting ``, or supplement to an application,'' 
        after ``application'' each place such term appears; and
            (2) by striking ``of a new'' and inserting ``for''.
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