Protecting Access to Medication Abortion Act of 2023

Subjects: Health

Summary:  <p><b>Protecting Access to Medication Abortion Act of 2023</b></p> <p>This bill requires the Food and Drug Administration (FDA) to ensure that patients may receive mifepristone through prescriptions issued via telehealth and filled by mail. The FDA has approved mifepristone for medication abortions (i.e., a procedure in which prescription drugs are used to terminate a pregnancy).</p> <p>(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 a requirement that the drug must be dispensed in person, a requirement in the strategy at the time. In January 2023, the FDA updated the strategy to remove the in-person dispensing requirement.)</p> <p>Under this bill, the FDA must ensure that the strategy for mifepristone (1) does not have an in-person dispensing requirement, (2) allows patients to access prescriptions for mifepristone via telehealth, and (3) authorizes all pharmacies certified to dispense mifepristone to patients to do so via mail. </p> <p> <p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 237 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                 S. 237

              To preserve access to abortion medications.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 2, 2023

Ms. Smith (for herself, Mr. Booker, Mrs. Gillibrand, Mr. Hickenlooper, 
  Mr. Kaine, Mr. King, Mr. Merkley, Mr. Padilla, Mr. Schatz, and Ms. 
   Stabenow) 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 of 2023''.

SEC. 2. MODIFICATION OF REMS.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall ensure that 
the risk evaluation and mitigation strategy under section 505-1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) that applies to 
mifepristone--
            (1) does not have an in-person dispensing requirement for 
        such drug;
            (2) allows for patient access to prescriptions for such 
        drug via telehealth; and
            (3) allows all pharmacies that are certified to dispense 
        such drug 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)), except that 
any modifications to such risk evaluation and mitigation strategy made 
after January 3, 2023, shall be in accordance with the requirements 
under paragraphs (1), (2), and (3) of subsection (a), 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).
                                 &lt;all&gt;
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