[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8405 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8405

              To preserve access to abortion medications.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 18, 2022

   Ms. Bush (for herself, Mr. Beyer, Ms. Omar, Ms. Jackson Lee, Ms. 
  McCollum, and Ms. Norton) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
              To preserve access to abortion medications.

    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 ``Protecting Access to Medication 
Abortion Act''.

SEC. 2. MODIFICATION OF REMS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall require the 
responsible person involved to submit a proposal under subsection 
(g)(4)(A) of section 505-1 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355-1) to modify the risk evaluation and mitigation strategy 
under such section that applies to mifepristone so that--
            (1) the in-person dispensing requirement is removed from 
        such risk evaluation and mitigation strategy;
            (2) patients may access prescriptions for such drug via 
        telehealth; and
            (3) all pharmacies that are certified to dispense such drug 
        are permitted to, at minimum, dispense and mail such drug to 
        patients.
    (b) Modifications.--Nothing in subsection (a) shall be construed to 
prevent the Secretary from approving a modification to the risk 
evaluation and mitigation strategy for mifepristone based on sound 
scientific evidence and in accordance with section 505-1(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(h)). Any 
modifications to such risk evaluation and mitigation strategy made 
after the proposal to modify required pursuant to subsection (a) shall 
be in accordance with the requirements under paragraphs (1), (2), and 
(3) of such subsection, unless the Secretary, based on sound scientific 
evidence and in accordance with section 505-1 of such Act (21 U.S.C. 
355-1), determines that a risk evaluation and mitigation strategy for 
mifepristone is no longer necessary.
    (c) Clarification.--Nothing in subsection (a) shall be construed to 
limit the authority of the Secretary to impose the requirements 
described in paragraphs (1), (2), and (3) of such subsection to a risk 
evaluation and mitigation strategy under section 505-1 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) for any drug other than 
mifepristone.
    (d) Definition.--In this section, the term ``mifepristone'' means 
mifepristone that is--
            (1) approved under subsection (c) or (j) of section 505 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
            (2) indicated for medical abortion; and
            (3) subject to a risk evaluation and mitigation strategy 
        under section 505-1 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355-1).
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