Protecting Access to Medication Abortion Act of 2023

Bill: 118-s-237
Sponsor: full_name: Sen. Smith, Tina [D-MN]
Introduced: 2023-02-02
Policy area: Health
Subjects: Abortion

Health care coverage and access

Health technology, devices, supplies

Prescription drugs
Latest action: action_date: 2023-02-02
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-02-02
action_desc: Introduced in Senate
text: <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>

tv_txt: II 118th CONGRESS 1st Session S. 237 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.

1. Short title This Act may be cited as the Protecting Access to Medication Abortion Act of 2023 . 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 ).