Protecting Access to Medication Abortion Act of 2023
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).
(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.)
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.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 767 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 767
To preserve access to abortion medications.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 2, 2023
Ms. Bush (for herself, Ms. Omar, Mr. Soto, Ms. Jackson Lee, Ms.
McCollum, Ms. Norton, Mr. Beyer, and Mr. Carson) 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 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).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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