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-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Support And Value 
Expectant Moms and Babies Act of 2023’’ or the ‘‘SAVE 
Moms and Babies Act of 2023’’. 
SEC. 2. ABORTION DRUGS PROHIBITED. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) (as amended by 
Public Law 117–328) is amended by adding at the end 
the following: 
‘‘(aa) ABORTION DRUGS.— 
‘‘(1) PROHIBITIONS.—The Secretary shall not 
approve— 
‘‘(A) any application submitted under sub-
section (b) or (j) for marketing an abortion 
drug; or 
‘‘(B) grant an investigational use exemp-
tion under subsection (i) for— 
‘‘(i) an abortion drug; or 
‘‘(ii) any investigation in which the 
unborn child of a woman known to be 
pregnant is knowingly destroyed. 
‘‘(2) 
PREVIOUSLY
APPROVED
ABORTION 
DRUGS.—If an approval described in paragraph (1) 
is in effect for an abortion drug as of the date of 
enactment of the Support And Value Expectant 
Moms and Babies Act of 2023, the Secretary shall— 
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‘‘(A) not approve any labeling change— 
‘‘(i) to approve the use of such abor-
tion drug after 70 days gestation; or 
‘‘(ii) to approve the dispensing of such 
abortion drug by any means other than in- 
person administration by the prescribing 
health care practitioner; 
‘‘(B) treat such abortion drug as subject to 
section 503(b)(1); and 
‘‘(C) require such abortion drug to be sub-
ject to a risk evaluation and mitigation strategy 
under section 505–1 that at a minimum— 
‘‘(i) requires health care practitioners 
who prescribe such abortion drug— 
‘‘(I) to be certified in accordance 
with the strategy; and 
‘‘(II) to not be acting in their ca-
pacity as a pharmacist; 
‘‘(ii) as part of the certification proc-
ess referred to in clause (i), requires such 
practitioners— 
‘‘(I) to have the ability to assess 
the duration of pregnancy accurately; 
‘‘(II) to have the ability to diag-
nose ectopic pregnancies; 
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‘‘(III) to have the ability to pro-
vide surgical intervention in cases of 
incomplete abortion or severe bleed-
ing; 
‘‘(IV) to have the ability to en-
sure patient access to medical facili-
ties equipped to provide blood trans-
fusions and resuscitation, if necessary; 
and 
‘‘(V) to report any deaths or 
other adverse events associated with 
the use of such abortion drug to the 
Food and Drug Administration and to 
the manufacturer of such abortion 
drug, identifying the patient by a non- 
identifiable reference and the serial 
number from each package of such 
abortion drug; 
‘‘(iii) limits the dispensing of such 
abortion drug to patients— 
‘‘(I) in a clinic, medical office, or 
hospital by means of in-person admin-
istration by the prescribing health 
care practitioner; and 
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‘‘(II) not in pharmacies or any 
setting other than the health care set-
tings described in subclause (I); 
‘‘(iv) requires the prescribing health 
care practitioner to give to the patient doc-
umentation on any risk of serious com-
plications associated with use of such abor-
tion drug and receive acknowledgment of 
such receipt from the patient; 
‘‘(v) requires all known adverse events 
associated with such abortion drug to be 
reported, excluding any individually identi-
fiable patient information, to the Food and 
Drug Administration by the— 
‘‘(I) manufacturers of such abor-
tion drug; and 
‘‘(II) prescribers of such abortion 
drug; and 
‘‘(vi) requires reporting of administra-
tion of the abortion drug as required by 
State law, or in the absence of a State law 
regarding such reporting, in the same 
manner as a surgical abortion. 
‘‘(3) REPORTING
ON
ADVERSE
EVENTS
BY 
OTHER
HEALTH
CARE
PRACTITIONERS.—The Sec-
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retary shall require all other health care practi-
tioners to report to the Food and Drug Administra-
tion any adverse events experienced by their patients 
that are connected to use of an abortion drug, ex-
cluding any individually identifiable patient informa-
tion. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to restrict the author-
ity of the Federal Government, or of a State, to es-
tablish, implement, and enforce requirements and re-
strictions with respect to abortion drugs under provi-
sions of law other than this section that are in addi-
tion to the requirements and restrictions under this 
section. 
‘‘(5) DEFINITIONS.—In this section: 
‘‘(A) The term ‘abortion drug’ means any 
drug, substance, or combination of drugs or 
substances that is intended for use or that is in 
fact used (irrespective of how the product is la-
beled) to intentionally kill the unborn child of 
a woman known to be pregnant, or to inten-
tionally terminate the pregnancy of a woman 
known to be pregnant, with an intention other 
than— 
‘‘(i) to produce a live birth; 
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‘‘(ii) to remove a dead unborn child; 
or 
‘‘(iii) to treat an ectopic pregnancy. 
‘‘(B) The term ‘adverse event’ includes 
each of the following: 
‘‘(i) A fatality. 
‘‘(ii) An ectopic pregnancy. 
‘‘(iii) A hospitalization. 
‘‘(iv) A blood loss requiring a trans-
fusion. 
‘‘(v) An infection, including endo-
metritis, pelvic inflammatory disease, and 
pelvic infections with sepsis. 
‘‘(vi) A severe infection. 
‘‘(C) The term ‘gestation’ means the pe-
riod of days beginning on the first day of the 
last menstrual period. 
‘‘(D) The term ‘health care practitioner’ 
means any individual who is licensed, reg-
istered, or otherwise permitted, by the United 
States or the jurisdiction in which the indi-
vidual practices, to prescribe drugs subject to 
section 503(b)(1). 
‘‘(E) The term ‘unborn child’ means an in-
dividual organism of the species homo sapiens, 
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beginning at fertilization, until the point of 
being born alive as defined in section 8(b) of 
title 1, United States Code.’’. 
(b) ONGOING INVESTIGATIONAL USE.—In the case of 
any investigational use of a drug pursuant to an investiga-
tional use exemption under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) that 
was granted before the date of enactment of this Act, such 
exemption is deemed to be rescinded as of the day that 
is 3 years after the date of enactment of this Act if the 
Secretary would be prohibited by section 505(aa)(1)(B) of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), from granting such exemption as of such 
day. 
Æ 
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