I 
117TH CONGRESS 
2D SESSION 
H. R. 8405 
To preserve access to abortion medications. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 18, 2022 
Ms. BUSH (for herself, Mr. BEYER, Ms. OMAR, Ms. JACKSON LEE, Ms. 
MCCOLLUM, and Ms. NORTON) 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 Representa-
tives 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’’. 
SEC. 2. MODIFICATION OF REMS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) 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 
VerDate Sep 11 2014 
06:00 Jul 21, 2022
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H8405.IH
H8405
pbinns on DSKJLVW7X2PROD with $$_JOB
U.S.C. 355–1) to modify the risk evaluation and mitiga-
tion strategy under such section that applies to 
mifepristone so that— 
(1) the in-person dispensing requirement is re-
moved from such risk evaluation and mitigation 
strategy; 
(2) patients may access prescriptions for such 
drug via telehealth; and 
(3) all pharmacies that are certified to dispense 
such drug are permitted to, at minimum, dispense 
and mail such drug to patients. 
(b) MODIFICATIONS.—Nothing in subsection (a) shall 
be construed to prevent the Secretary from approving a 
modification to the risk evaluation and mitigation strategy 
for mifepristone based on sound scientific evidence and in 
accordance with section 505–1(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355–1(h)). Any modi-
fications to such risk evaluation and mitigation strategy 
made after the proposal to modify required pursuant to 
subsection (a) shall be in accordance with the require-
ments under paragraphs (1), (2), and (3) of such sub-
section, unless the Secretary, based on sound scientific evi-
dence and in accordance with section 505–1 of such Act 
(21 U.S.C. 355–1), determines that a risk evaluation and 
VerDate Sep 11 2014 
06:00 Jul 21, 2022
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H8405.IH
H8405
pbinns on DSKJLVW7X2PROD with $$_JOB
mitigation strategy for mifepristone is no longer nec-
essary. 
(c) CLARIFICATION.—Nothing in subsection (a) shall 
be construed to limit the authority of the Secretary to im-
pose the requirements described in paragraphs (1), (2), 
and (3) of such subsection to a risk evaluation and mitiga-
tion 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 sec-
tion 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). 
Æ 
VerDate Sep 11 2014 
06:00 Jul 21, 2022
Jkt 029200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\H8405.IH
H8405
pbinns on DSKJLVW7X2PROD with $$_JOB