What This Bill Does
This bill requires the federal government to change how it regulates mifepristone (a medication used for medical abortion). The bill directs the Secretary of Health and Human Services to remove certain restrictions from the current safety requirements for this drug. These changes would make the medication more accessible to patients.
Who It Affects
- The Secretary of Health and Human Services
- Patients seeking access to mifepristone
- Pharmacies that dispense mifepristone
Key Provisions
- The government cannot require patients to pick up mifepristone in person at a doctor's office or clinic (Sec. 2(a)(1))
- Patients must be allowed to get prescriptions for mifepristone through telehealth, which is remote medical visits (Sec. 2(a)(2))
- All pharmacies approved to dispense mifepristone must be allowed to mail the drug to patients, at minimum (Sec. 2(a)(3))
- Any changes made to the drug's safety requirements after January 3, 2023, must follow these three requirements unless the Secretary determines the safety strategy is no longer necessary based on scientific evidence (Sec. 2(b))
What Changes
If this becomes law, mifepristone would no longer require in-person doctor visits to obtain. Patients could consult with doctors remotely and receive the medication by mail from approved pharmacies.
Important Definitions
- Mifepristone: A medication approved by the federal government for medical abortion and subject to federal safety requirements (Sec. 2(d))
- Telehealth: Medical services provided remotely, typically through technology like video calls (implied in Sec. 2(a)(2))
I
118TH CONGRESS
1ST SESSION
H. R. 767
To preserve access to abortion medications.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 2, 2023
Ms. BUSH (for herself, Ms. OMAR, Mr. SOTO, Ms. JACKSON LEE, Ms. MCCOL-
LUM, Ms. NORTON, Mr. BEYER, and Mr. CARSON) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce
A BILL
To preserve access to abortion medications.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Protecting Access to
4
Medication Abortion Act of 2023’’.
5
SEC. 2. MODIFICATION OF REMS.
6
(a) IN GENERAL.—The Secretary of Health and
7
Human Services (referred to in this section as the ‘‘Sec-
8
retary’’) shall ensure that the risk evaluation and mitiga-
9
tion strategy under section 505–1 of the Federal Food,
10
VerDate Sep 11 2014
00:05 Feb 24, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H767.IH
H767
kjohnson on DSK79L0C42PROD with BILLS
2
•HR 767 IH
Drug, and Cosmetic Act (21 U.S.C. 355–1) that applies
1
to mifepristone—
2
(1) does not have an in-person dispensing re-
3
quirement for such drug;
4
(2) allows for patient access to prescriptions for
5
such drug via telehealth; and
6
(3) allows all pharmacies that are certified to
7
dispense such drug to, at minimum, dispense and
8
mail such drug to patients.
9
(b) MODIFICATIONS.—Nothing in subsection (a) shall
10
be construed to prevent the Secretary from approving a
11
modification to the risk evaluation and mitigation strategy
12
for mifepristone based on sound scientific evidence and in
13
accordance with section 505–1(h) of the Federal Food,
14
Drug, and Cosmetic Act (21 U.S.C. 355–1(h)), except
15
that any modifications to such risk evaluation and mitiga-
16
tion strategy made after January 3, 2023, shall be in ac-
17
cordance with the requirements under paragraphs (1), (2),
18
and (3) of subsection (a), unless the Secretary, based on
19
sound scientific evidence and in accordance with section
20
505–1 of such Act (21 U.S.C. 355–1), determines that
21
a risk evaluation and mitigation strategy for mifepristone
22
is no longer necessary.
23
(c) CLARIFICATION.—Nothing in subsection (a) shall
24
be construed to limit the authority of the Secretary to im-
25
VerDate Sep 11 2014
00:05 Feb 24, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H767.IH
H767
kjohnson on DSK79L0C42PROD with BILLS
3
•HR 767 IH
pose the requirements described in paragraphs (1), (2),
1
and (3) of such subsection to a risk evaluation and mitiga-
2
tion strategy under section 505–1 of the Federal Food,
3
Drug, and Cosmetic Act (21 U.S.C. 355–1) for any drug
4
other than mifepristone.
5
(d)
DEFINITION.—In
this
section,
the
term
6
‘‘mifepristone’’ means mifepristone that is—
7
(1) approved under subsection (c) or (j) of sec-
8
tion 505 of the Federal Food, Drug, and Cosmetic
9
Act (21 U.S.C. 355);
10
(2) indicated for medical abortion; and
11
(3) subject to a risk evaluation and mitigation
12
strategy under section 505–1 of the Federal Food,
13
Drug, and Cosmetic Act (21 U.S.C. 355–1).
14
Æ
VerDate Sep 11 2014
00:05 Feb 24, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\H767.IH
H767
kjohnson on DSK79L0C42PROD with BILLS