II 

117TH CONGRESS 

2D SESSION S. 4467 

To preserve access to abortion medications. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Access to 

5 Medication Abortion Act’’. 

6 SEC. 2. MODIFICATION OF REMS. 

7 (a) IN GENERAL.—The Secretary of Health and 

8 Human Services (referred to in this section as the ‘‘Sec9 retary’’) shall require the responsible person involved to 

10 submit a proposal under subsection (g)(4)(A) of section 

11 505–1 of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 355–1) to modify the risk evaluation and mitigaVerDate Sep 11 2014 00:48 Jun 30, 2022 Jkt 029200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4467.IS S4467

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•S 4467 IS

1 tion strategy under such section that applies to 

2 mifepristone so that— 

3 (1) the in-person dispensing requirement is re4 moved from such risk evaluation and mitigation 

5 strategy; 

6 (2) patients may access prescriptions for such 

7 drug via telehealth; and 

8 (3) all pharmacies that are certified to dispense 

9 such drug are permitted to, at minimum, dispense 

10 and mail such drug to patients. 

11 (b) MODIFICATIONS.—Nothing in subsection (a) shall 

12 be construed to prevent the Secretary from approving a 

13 modification to the risk evaluation and mitigation strategy 

14 for mifepristone based on sound scientific evidence and in 

15 accordance with section 505–1(h) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 355–1(h)). Any modi17 fications to such risk evaluation and mitigation strategy 

18 made after the proposal to modify required pursuant to 

19 subsection (a) shall be in accordance with the require20 ments under paragraphs (1), (2), and (3) of such sub21 section, unless the Secretary, based on sound scientific evi22 dence and in accordance with section 505–1 of such Act 

23 (21 U.S.C. 355–1), determines that a risk evaluation and 

24 mitigation strategy for mifepristone is no longer nec25 essary. 


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1 (c) CLARIFICATION.—Nothing in subsection (a) shall 

2 be construed to limit the authority of the Secretary to im3 pose the requirements described in paragraphs (1), (2), 

4 and (3) of such subsection to a risk evaluation and mitiga5 tion strategy under section 505–1 of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 355–1) for any drug 

7 other than mifepristone. 

8 (d) DEFINITION.—In this section, the term 

9 ‘‘mifepristone’’ means mifepristone that is— 

10 (1) approved under subsection (c) or (j) of sec11 tion 505 of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 355); 

13 (2) indicated for medical abortion; and 

14 (3) subject to a risk evaluation and mitigation 

15 strategy under section 505–1 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 355–1). 

Æ 


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