What This Bill Does
This bill amends federal drug approval rules to stop the government from approving new abortion drugs and to add strict requirements for drugs already approved for abortion use. The bill also prevents the government from allowing test uses of abortion drugs on patients, except for specific medical situations like removing a dead fetus or treating an ectopic pregnancy (a pregnancy that grows outside the uterus).
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Who It Affects
- The Food and Drug Administration (the federal agency that approves drugs)
- Doctors and health care providers who prescribe medications
- Pharmaceutical companies that make drugs
- Pregnant women who might use abortion drugs
- All other health care practitioners (nurses, physician assistants, etc.)
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Key Provisions
- The Food and Drug Administration cannot approve new drugs intended to end a pregnancy, with exceptions only for removing a dead fetus or treating an ectopic pregnancy (Sec. 2(a)(1))
- The Food and Drug Administration cannot allow doctors to test abortion drugs on patients, except for removing a dead fetus or treating an ectopic pregnancy (Sec. 2(a)(1))
- Drugs already approved for abortion use cannot be changed to allow use after 70 days of gestation or to allow patients to take them at home instead of at a doctor's office (Sec. 2(a)(2)(A))
- Doctors who prescribe abortion drugs must be certified and must be able to accurately determine how far along a pregnancy is, diagnose ectopic pregnancies, handle incomplete abortions or severe bleeding, and ensure patients can access blood transfusions and emergency resuscitation if needed (Sec. 2(a)(2)(C))
- Doctors must give patients written information about serious risks and get the patient to sign that they received this information (Sec. 2(a)(2)(C))
- Abortion drugs can only be given in person at a clinic, medical office, or hospital, never through a pharmacy or by mail (Sec. 2(a)(2)(C))
- Doctors and drug manufacturers must report any deaths or serious medical problems to the Food and Drug Administration, including infections, blood loss requiring transfusions, and hospitalizations, while keeping patient names private (Sec. 2(a)(2)(C) and 2(a)(3))
- All other health care practitioners must report any serious medical problems their patients experience from abortion drugs to the Food and Drug Administration without sharing patient names (Sec. 2(a)(3))
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What Changes
If this bill becomes law, the government will be required to stop approving new abortion drugs and will be required to apply strict new rules to any abortion drugs currently on the market. These rules require doctors to be specially certified, give detailed risk information to patients in writing, give the drug only in a medical office or hospital (never mailed or through pharmacies), and report any serious health problems to the Food and Drug Administration. Any ongoing tests of abortion drugs on patients would automatically stop three years after this law passes, unless the drug meets the exceptions for treating ectopic pregnancies or removing a dead fetus.
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Important Definitions
- "Abortion drug" means any medication that is used to intentionally kill a fetus or end a pregnancy, except when the purpose is to produce a live birth, remove a dead fetus, or treat an ectopic pregnancy
- "Adverse event" means a death, ectopic pregnancy, hospitalization, blood loss needing transfusion, or infection (including endometritis, pelvic inflammatory disease, or pelvic infections with sepsis)
- "Gestation" means the number of days from the first day of the last menstrual period
- "Health care practitioner" means any person licensed or registered to prescribe prescription drugs (drugs that require a doctor's order)
- "Unborn child" means a human organism starting at fertilization until birth
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Effective Date
Not specified in bill text
I
118TH CONGRESS
1ST SESSION
H. R. 427
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 HOUSE OF REPRESENTATIVES
JANUARY 20, 2023
Mr. LATTA
(for himself, Mrs. HARSHBARGER, Mr. ADERHOLT, Mr.
RESCHENTHALER, Ms. LETLOW, Mr. FINSTAD, Mr. GROTHMAN, Mr.
LUETKEMEYER, Mr. DUNN of Florida, Mr. BOST, Mr. BABIN, Mr. PALM-
ER, Mr. WENSTRUP, Mr. ELLZEY, Mrs. MILLER of Illinois, Mr. SMITH
of New Jersey, Mr. BANKS, Mr. FEENSTRA, Mr. PFLUGER, Mr. BIGGS,
Mr. C. SCOTT FRANKLIN of Florida, Mr. WEBER of Texas, Mr.
WALBERG, Mr. LAHOOD, Mr. JACKSON of Texas, Mr. MANN, Mr.
BALDERSON, Mr. ROSE, Mr. GUEST, Mrs. BOEBERT, Mr. WALTZ, Mr.
PERRY, and Mr. MCHENRY) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce
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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•HR 427 IH
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) (as amended by
7
Public Law 117–328) is amended by adding at the end
8
the following:
9
‘‘(aa) ABORTION DRUGS.—
10
‘‘(1) PROHIBITIONS.—The Secretary shall not
11
approve—
12
‘‘(A) any application submitted under sub-
13
section (b) or (j) for marketing an abortion
14
drug; or
15
‘‘(B) grant an investigational use exemp-
16
tion under subsection (i) for—
17
‘‘(i) an abortion drug; or
18
‘‘(ii) any investigation in which the
19
unborn child of a woman known to be
20
pregnant is knowingly destroyed.
21
‘‘(2)
PREVIOUSLY
APPROVED
ABORTION
22
DRUGS.—If an approval described in paragraph (1)
23
is in effect for an abortion drug as of the date of
24
enactment of the Support And Value Expectant
25
Moms and Babies Act of 2023, the Secretary shall—
26
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•HR 427 IH
‘‘(A) not approve any labeling change—
1
‘‘(i) to approve the use of such abor-
2
tion drug after 70 days gestation; or
3
‘‘(ii) to approve the dispensing of such
4
abortion drug by any means other than in-
5
person administration by the prescribing
6
health care practitioner;
7
‘‘(B) treat such abortion drug as subject to
8
section 503(b)(1); and
9
‘‘(C) require such abortion drug to be sub-
10
ject to a risk evaluation and mitigation strategy
11
under section 505–1 that at a minimum—
12
‘‘(i) requires health care practitioners
13
who prescribe such abortion drug—
14
‘‘(I) to be certified in accordance
15
with the strategy; and
16
‘‘(II) to not be acting in their ca-
17
pacity as a pharmacist;
18
‘‘(ii) as part of the certification proc-
19
ess referred to in clause (i), requires such
20
practitioners—
21
‘‘(I) to have the ability to assess
22
the duration of pregnancy accurately;
23
‘‘(II) to have the ability to diag-
24
nose ectopic pregnancies;
25
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•HR 427 IH
‘‘(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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•HR 427 IH
‘‘(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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•HR 427 IH
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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•HR 427 IH
‘‘(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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•HR 427 IH
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(aa)(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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