I 
116TH CONGRESS 
1ST SESSION H. R. 4399 
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 
SEPTEMBER 19, 2019 
Mr. LATTA (for himself, Mrs. WAGNER, Mr. NORMAN, Mr. OLSON, Mr. LAM-
BORN, Mr. MEADOWS, Mr. ALLEN, Mr. WILLIAMS, Mr. SMITH of New 
Jersey, Mr. WEBER of Texas, Mr. WATKINS, Mr. GIANFORTE, Mr. 
CHABOT, Mr. BABIN, Mr. RATCLIFFE, Mr. LOUDERMILK, Mr. RUTHER-
FORD, Mr. LAMALFA, Mr. FLORES, Mr. KEVIN HERN of Oklahoma, Mr. 
ABRAHAM, Mr. HARRIS, Mrs. HARTZLER, Mr. ESTES, Mr. GIBBS, Mr. 
GROTHMAN, Mr. WITTMAN, Ms. FOXX of North Carolina, Mr. WALBERG, 
and Mr. HIGGINS of Louisiana) 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-
tives of the United States of America in Congress assembled, 
VerDate Sep 11 2014 
21:44 Sep 20, 2019
Jkt 089200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Support And Value 
Expectant Moms and Babies Act of 2019’’ or the ‘‘SAVE 
Moms and Babies Act of 2019’’. 
SEC. 2. ABORTION DRUGS PROHIBITED. 
(a) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following: 
‘‘(z) 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 
human embryo or human fetus of a woman 
known to be pregnant is knowingly de-
stroyed. 
‘‘(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 2019, the Secretary shall— 
VerDate Sep 11 2014 
20:08 Sep 24, 2019
Jkt 089200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
‘‘(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; 
VerDate Sep 11 2014 
21:44 Sep 20, 2019
Jkt 089200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
‘‘(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 
VerDate Sep 11 2014 
20:08 Sep 24, 2019
Jkt 089200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
‘‘(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-
VerDate Sep 11 2014 
21:44 Sep 20, 2019
Jkt 089200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
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 Secretary, or of a State, to establish, im-
plement, and enforce requirements and restrictions 
with respect to abortion drugs under provisions of 
law other than this section that are in addition 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)— 
‘‘(i) to intentionally kill the unborn 
child of a woman known to be pregnant; or 
‘‘(ii) to intentionally terminate the 
pregnancy of a woman known to be preg-
nant, with an intention other than— 
‘‘(I) to produce a live birth; or 
VerDate Sep 11 2014 
21:44 Sep 20, 2019
Jkt 089200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
‘‘(II) to remove a dead unborn 
child. 
‘‘(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, 
beginning at fertilization, until the point of 
VerDate Sep 11 2014 
21:44 Sep 20, 2019
Jkt 089200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS
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(z)(1)(B) of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a), from granting such exemption as of such 
day. 
Æ 
VerDate Sep 11 2014 
21:44 Sep 20, 2019
Jkt 089200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6301
E:\BILLS\H4399.IH
H4399
kjohnson on DSK79L0C42 with BILLS