Protecting Access to Medication Abortion Act

Bill: 117-s-4467
Sponsor: full_name: Sen. Smith, Tina [D-MN]
Introduced: 2022-06-23
Policy area: Health
Subjects: Abortion

Health care coverage and access

Health technology, devices, supplies

Prescription drugs
Latest action: action_date: 2022-06-23
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2022-06-23
action_desc: Introduced in Senate
text: <p><strong>Protecting Access to Medication Abortion Act</strong></p> <p>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. </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 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.)</p> <p>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.</p>

tv_txt: II 117th CONGRESS 2d Session S. 4467 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.

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