I
119THCONGRESS
1
STSESSION H. R. 685
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
JANUARY23, 2025
Mr. L
ATTA(for himself, Mr. ROUZER, Mr. BRECHEEN, Mr. STRONG, Mrs.
M
ILLERof Illinois, Mr. WEBSTERof Florida, Mr. FINSTAD, Mr. ADER-
HOLT, Mr. FEENSTRA, Mr. SMITHof New Jersey, Mr. FULCHER, Mr.
F
LOOD, Mr. MANN, Mr. HARRISof Maryland, Mr. FONG, Mr. ELLZEY,
Mr. W
EBERof Texas, Mr. MCCORMICK, Mr. MOOLENAAR, Mr. OGLES,
Mr. G
UEST, Mr. HIGGINSof Louisiana, Mr. PALMER, Mr. MOOREof
North Carolina, Mr. S
HREVE, and Mr. LAHOOD) introduced the following
bill; which was referred 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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SECTION 1. SHORT TITLE. 1
This Act may be cited as the ‘‘Support And Value 2
Expectant Moms and Babies Act of 2025’’ or the ‘‘SAVE 3
Moms and Babies Act of 2025’’. 4
SEC. 2. ABORTION DRUGS PROHIBITED. 5
(a) I
NGENERAL.—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) A
BORTIONDRUGS.— 10
‘‘(1) P
ROHIBITIONS.—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) P
REVIOUSLY 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 2025, the Secretary shall— 26
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‘‘(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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‘‘(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) R
EPORTING ON ADVERSE EVENTS BY 24
OTHER HEALTH CARE PRACTITIONERS .—The Sec-25
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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) R
ULE 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) D
EFINITIONS.—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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‘‘(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) O
NGOINGINVESTIGATIONALUSE.—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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