Title: Protecting Access to Medication Abortion Act
Policy area: Health

Summary:
Protecting Access to Medication Abortion Act
This bill directs the Food and Drug Administration (FDA) to take steps to allow patients to receive prescriptions for mifepristone, a drug approved by the FDA for medical abortion, via telehealth and for prescriptions for the drug to be filled by mail.
(Mifepristone is subject to a Risk Evaluation and Mitigation Strategy, which imposes various safety-related requirements. During the COVID-19 public health emergency, the FDA suspended enforcement of the current strategy's requirement that the drug must be dispensed in person, and this suspension is still in effect. In December 2021, the FDA stated the data supported modifying the strategy to remove the in-person dispensing requirement.)
Under this bill, the FDA must require the holder of the relevant approved drug application to submit a proposal to modify the strategy. The modification shall (1) remove the in-person dispensing requirement, (2) allow patients to access prescriptions for mifepristone via telehealth, and (3) authorize all pharmacies certified to dispense mifepristone to patients to do so via mail.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4467 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 4467

              To preserve access to abortion medications.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 23, 2022

   Ms. Smith introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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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