What This Bill Does
This bill changes how the federal government handles abortion drugs. It prevents approval of new abortion drugs and blocks emergency investigational use for abortion drugs. It also adds new requirements for abortion drugs already approved by the Food and Drug Administration.
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Who It Affects
- The Food and Drug Administration (the agency that approves medications)
- Health care practitioners who prescribe abortion drugs (doctors and other licensed prescribers)
- Patients seeking abortion drugs
- Manufacturers of abortion drugs
- States and the federal government
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Key Provisions
- The Food and Drug Administration cannot approve any new applications for abortion drugs, and cannot grant emergency experimental use permissions for abortion drugs (Sec. 2(a))
- For abortion drugs already approved, the Food and Drug Administration cannot approve changes that would allow use after 70 days of pregnancy or allow these drugs to be dispensed by any method other than in-person administration by the prescribing health care practitioner (Sec. 2(a))
- Health care practitioners who prescribe abortion drugs must be certified and must have the ability to assess pregnancy duration, diagnose ectopic pregnancies (pregnancies outside the uterus), provide surgical intervention for incomplete abortion or severe bleeding, and ensure patients can access blood transfusions and resuscitation services if needed (Sec. 2(a))
- Health care practitioners must report any deaths or other serious health complications related to abortion drugs to the Food and Drug Administration and the drug manufacturer (Sec. 2(a))
- These abortion drugs can only be given in clinics, medical offices, or hospitals through in-person administration by the prescribing health care practitioner, not in pharmacies or through mail (Sec. 2(a))
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What Changes
If this becomes law, doctors and other health care practitioners would face new certification requirements to prescribe abortion drugs. Patients could only receive these drugs in person at medical facilities, not by mail or through pharmacies. The Food and Drug Administration would be blocked from approving any new abortion drugs or allowing experimental use of abortion drugs. All serious health problems related to abortion drugs would have to be reported to the federal government. States could add their own additional rules on top of these federal rules.
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Important Definitions
- "Abortion drug" means any drug intended to kill an unborn child of a pregnant woman or end a pregnancy, except when producing a live birth, removing a dead unborn child, or treating an ectopic pregnancy
- "Adverse event" includes deaths, ectopic pregnancies, hospitalizations, blood loss requiring transfusion, infections (including endometritis, pelvic inflammatory disease, and infected pelvic areas with sepsis), and severe infections
- "Gestation" means the number of days beginning on the first day of the last menstrual period
- "Health care practitioner" means any person licensed, registered, or permitted to prescribe prescription drugs
- "Unborn child" means an individual human organism from fertilization until birth
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Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 95
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval
of new abortion drugs, to prohibit investigational use exemptions for
abortion drugs, and to impose additional regulatory requirements with
respect to previously approved abortion drugs, and for other purposes.
IN THE SENATE OF THE UNITED STATES
JANUARY 26, 2023
Mrs. HYDE-SMITH (for herself, Mr. DAINES, Mr. RISCH, Mr. BRAUN, Mrs.
FISCHER, Mr. CRAPO, Mr. HOEVEN, Mr. CRAMER, Mr. RUBIO, Mr.
WICKER, Mr. HAWLEY, Mr. MARSHALL, Mr. COTTON, Mr. LANKFORD,
Mr. LEE, Mr. BARRASSO, Mr. CORNYN, Mr. SCOTT of Florida, Mr. CRUZ,
Mr. THUNE, Mr. HAGERTY, Ms. LUMMIS, Mrs. BLACKBURN, Mr. YOUNG,
and Mr. GRAHAM, AND MR. RICKETTS) introduced the following bill;
which was read twice and referred to the Committee on Health, Edu-
cation, Labor, and Pensions
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
prohibit the approval of new abortion drugs, to prohibit
investigational use exemptions for abortion drugs, and
to impose additional regulatory requirements with respect
to previously approved abortion drugs, and for other
purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
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•S 95 IS
SECTION 1. SHORT TITLE.
1
This Act may be cited as the ‘‘Support And Value
2
Expectant Moms and Babies Act of 2023’’ or the ‘‘SAVE
3
Moms and Babies Act of 2023’’.
4
SEC. 2. ABORTION DRUGS PROHIBITED.
5
(a) IN GENERAL.—Section 505 of the Federal Food,
6
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by
7
adding at the end the following:
8
‘‘(z) ABORTION DRUGS.—
9
‘‘(1) PROHIBITIONS.—The Secretary shall not
10
approve—
11
‘‘(A) any application submitted under sub-
12
section (b) or (j) for marketing an abortion
13
drug; or
14
‘‘(B) grant an investigational use exemp-
15
tion under subsection (i) for—
16
‘‘(i) an abortion drug; or
17
‘‘(ii) any investigation in which the
18
unborn child of a woman known to be
19
pregnant is knowingly destroyed.
20
‘‘(2)
PREVIOUSLY
APPROVED
ABORTION
21
DRUGS.—If an approval described in paragraph (1)
22
is in effect for an abortion drug as of the date of
23
enactment of the Support And Value Expectant
24
Moms and Babies Act of 2023, the Secretary shall—
25
‘‘(A) not approve any labeling change—
26
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•S 95 IS
‘‘(i) to approve the use of such abor-
1
tion drug after 70 days gestation; or
2
‘‘(ii) to approve the dispensing of such
3
abortion drug by any means other than in-
4
person administration by the prescribing
5
health care practitioner;
6
‘‘(B) treat such abortion drug as subject to
7
section 503(b)(1); and
8
‘‘(C) require such abortion drug to be sub-
9
ject to a risk evaluation and mitigation strategy
10
under section 505–1 that at a minimum—
11
‘‘(i) requires health care practitioners
12
who prescribe such abortion drug—
13
‘‘(I) to be certified in accordance
14
with the strategy; and
15
‘‘(II) to not be acting in their ca-
16
pacity as a pharmacist;
17
‘‘(ii) as part of the certification proc-
18
ess referred to in clause (i), requires such
19
practitioners—
20
‘‘(I) to have the ability to assess
21
the duration of pregnancy accurately;
22
‘‘(II) to have the ability to diag-
23
nose ectopic pregnancies;
24
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‘‘(III) to have the ability to pro-
1
vide surgical intervention in cases of
2
incomplete abortion or severe bleed-
3
ing;
4
‘‘(IV) to have the ability to en-
5
sure patient access to medical facili-
6
ties equipped to provide blood trans-
7
fusions and resuscitation, if necessary;
8
and
9
‘‘(V) to report any deaths or
10
other adverse events associated with
11
the use of such abortion drug to the
12
Food and Drug Administration and to
13
the manufacturer of such abortion
14
drug, identifying the patient by a non-
15
identifiable reference and the serial
16
number from each package of such
17
abortion drug;
18
‘‘(iii) limits the dispensing of such
19
abortion drug to patients—
20
‘‘(I) in a clinic, medical office, or
21
hospital by means of in-person admin-
22
istration by the prescribing health
23
care practitioner; and
24
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‘‘(II) not in pharmacies or any
1
setting other than the health care set-
2
tings described in subclause (I);
3
‘‘(iv) requires the prescribing health
4
care practitioner to give to the patient doc-
5
umentation on any risk of serious com-
6
plications associated with use of such abor-
7
tion drug and receive acknowledgment of
8
such receipt from the patient;
9
‘‘(v) requires all known adverse events
10
associated with such abortion drug to be
11
reported, excluding any individually identi-
12
fiable patient information, to the Food and
13
Drug Administration by the—
14
‘‘(I) manufacturers of such abor-
15
tion drug; and
16
‘‘(II) prescribers of such abortion
17
drug; and
18
‘‘(vi) requires reporting of administra-
19
tion of the abortion drug as required by
20
State law, or in the absence of a State law
21
regarding such reporting, in the same
22
manner as a surgical abortion.
23
‘‘(3) REPORTING
ON
ADVERSE
EVENTS
BY
24
OTHER
HEALTH
CARE
PRACTITIONERS.—The Sec-
25
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•S 95 IS
retary shall require all other health care practi-
1
tioners to report to the Food and Drug Administra-
2
tion any adverse events experienced by their patients
3
that are connected to use of an abortion drug, ex-
4
cluding any individually identifiable patient informa-
5
tion.
6
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in
7
this section shall be construed to restrict the author-
8
ity of the Federal Government, or of a State, to es-
9
tablish, implement, and enforce requirements and re-
10
strictions with respect to abortion drugs under provi-
11
sions of law other than this section that are in addi-
12
tion to the requirements and restrictions under this
13
section.
14
‘‘(5) DEFINITIONS.—In this section:
15
‘‘(A) The term ‘abortion drug’ means any
16
drug, substance, or combination of drugs or
17
substances that is intended for use or that is in
18
fact used (irrespective of how the product is la-
19
beled) to intentionally kill the unborn child of
20
a woman known to be pregnant, or to inten-
21
tionally terminate the pregnancy of a woman
22
known to be pregnant, with an intention other
23
than—
24
‘‘(i) to produce a live birth;
25
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•S 95 IS
‘‘(ii) to remove a dead unborn child;
1
or
2
‘‘(iii) to treat an ectopic pregnancy.
3
‘‘(B) The term ‘adverse event’ includes
4
each of the following:
5
‘‘(i) A fatality.
6
‘‘(ii) An ectopic pregnancy.
7
‘‘(iii) A hospitalization.
8
‘‘(iv) A blood loss requiring a trans-
9
fusion.
10
‘‘(v) An infection, including endo-
11
metritis, pelvic inflammatory disease, and
12
pelvic infections with sepsis.
13
‘‘(vi) A severe infection.
14
‘‘(C) The term ‘gestation’ means the pe-
15
riod of days beginning on the first day of the
16
last menstrual period.
17
‘‘(D) The term ‘health care practitioner’
18
means any individual who is licensed, reg-
19
istered, or otherwise permitted, by the United
20
States or the jurisdiction in which the indi-
21
vidual practices, to prescribe drugs subject to
22
section 503(b)(1).
23
‘‘(E) The term ‘unborn child’ means an in-
24
dividual organism of the species homo sapiens,
25
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beginning at fertilization, until the point of
1
being born alive as defined in section 8(b) of
2
title 1, United States Code.’’.
3
(b) ONGOING INVESTIGATIONAL USE.—In the case of
4
any investigational use of a drug pursuant to an investiga-
5
tional use exemption under section 505(i) of the Federal
6
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) that
7
was granted before the date of enactment of this Act, such
8
exemption is deemed to be rescinded as of the day that
9
is 3 years after the date of enactment of this Act if the
10
Secretary would be prohibited by section 505(z)(1)(B) of
11
the Federal Food, Drug, and Cosmetic Act, as added by
12
subsection (a), from granting such exemption as of such
13
day.
14
Æ
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