117 S4467 IS: Protecting Access to Medication Abortion Act U.S. Senate 2022-06-23 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS2d SessionS. 4467IN THE SENATE OF THE UNITED STATESJune 23, 2022Ms. Smith introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo 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).