Title: To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.
Policy area: Health

Summary:
This bill requires the Food and Drug Administration to solicit public comment on factors that should be taken into account when considering proposed modifications to approved risk evaluation and mitigation strategies for drugs. The Government Accountability Office must report on the number of proposed modifications that have been granted and the related effects on patient access or provider administration with respect to such drugs.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7649 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 7649

 To direct the Secretary of Health and Human Services to open a public 
  docket for the submission of public comments regarding factors that 
     should be taken into consideration when reviewing a proposed 
 modification to an approved risk evaluation and mitigation strategy, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 3, 2022

 Mr. Joyce of Pennsylvania (for himself, Ms. Matsui, and Mr. Griffith) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To direct the Secretary of Health and Human Services to open a public 
  docket for the submission of public comments regarding factors that 
     should be taken into consideration when reviewing a proposed 
 modification to an approved risk evaluation and mitigation strategy, 
                        and for other purposes.

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

SECTION 1. PUBLIC DOCKET ON PROPOSED MODIFICATIONS TO APPROVED 
              STRATEGIES.

    (a) In General.--Not later than 90 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
open a public docket for the submission of public comments regarding 
factors that should be taken into consideration when a proposed 
modification to an approved risk evaluation and mitigation strategy is 
reviewed under section 505-1(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 255-1(h)), including factors related to patient access 
to the drug that is the subject of the strategy and provider 
administration. The Secretary may close such public docket not earlier 
than 90 days after such docket is opened.
    (b) GAO Report.--Not later than December 31, 2026, the Comptroller 
General of the United States shall submit to the Committee on Energy 
and Commerce of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a report on--
            (1) the number of proposed modifications to an approved 
        risk evaluation and mitigation strategy the Secretary has 
        granted under section 505-1(h) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 255-1(h));
            (2) any issues affecting patient access to the drug that is 
        the subject of the strategy or provider administration that 
        arose as a result of such modifications; and
            (3) how such issues were resolved, as applicable.
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