[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8586 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8586

To allow the Secretary of Health and Human Services to deny approval of 
  a new drug application for an opioid analgesic drug on the basis of 
such drug not being clinically superior to other commercially available 
                                 drugs.


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                    IN THE HOUSE OF REPRESENTATIVES

                             July 28, 2022

 Mr. Trone (for himself and Mr. Meuser) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

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                                 A BILL


 
To allow the Secretary of Health and Human Services to deny approval of 
  a new drug application for an opioid analgesic drug on the basis of 
such drug not being clinically superior to other commercially available 
                                 drugs.

    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 ``Ensuring the FDA Fully Examines 
Clinical Trial Impact and Vitalness before Endorsement Act'' or the 
``EFFECTIVE Act''.

SEC. 2. REQUIREMENT FOR APPROVAL OF NEW OPIOID ANALGESICS.

    Section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(c)) is amended by adding at the end the following:
    ``(6) Notwithstanding any other provision of this section, the 
Secretary may deny approval of an application submitted under 
subsection (b) for an opioid analgesic drug if the Secretary determines 
that such drug does not provide a significant advantage or clinical 
superiority, in terms of greater safety or effectiveness, compared to 
an appropriate comparator drug, as determined by the Secretary.''.
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