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. LAMBORN, 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. RUTHERFORD, 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Support And Value 

3 Expectant Moms and Babies Act of 2019’’ or the ‘‘SAVE 

4 Moms and Babies Act of 2019’’. 

5 SEC. 2. ABORTION DRUGS PROHIBITED. 

6 (a) IN GENERAL.—Section 505 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 

8 adding at the end the following: 

9 ‘‘(z) ABORTION DRUGS.— 

10 ‘‘(1) PROHIBITIONS.—The Secretary shall not 

11 approve— 

12 ‘‘(A) any application submitted under sub13 section (b) or (j) for marketing an abortion 

14 drug; or 

15 ‘‘(B) grant an investigational use exemp16 tion under subsection (i) for— 

17 ‘‘(i) an abortion drug; or 

18 ‘‘(ii) any investigation in which the 

19 human embryo or human fetus of a woman 

20 known to be pregnant is knowingly de21 stroyed. 

22 ‘‘(2) PREVIOUSLY APPROVED ABORTION

23 DRUGS.—If an approval described in paragraph (1) 

24 is in effect for an abortion drug as of the date of 

25 enactment of the Support And Value Expectant 

26 Moms and Babies Act of 2019, the Secretary shall— 


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1 ‘‘(A) not approve any labeling change— 

2 ‘‘(i) to approve the use of such abor3 tion drug after 70 days gestation; or 

4 ‘‘(ii) to approve the dispensing of such 

5 abortion drug by any means other than in6 person administration by the prescribing 

7 health care practitioner; 

8 ‘‘(B) treat such abortion drug as subject to 

9 section 503(b)(1); and 

10 ‘‘(C) require such abortion drug to be sub11 ject to a risk evaluation and mitigation strategy 

12 under section 505–1 that at a minimum— 

13 ‘‘(i) requires health care practitioners 

14 who prescribe such abortion drug— 

15 ‘‘(I) to be certified in accordance 

16 with the strategy; and 

17 ‘‘(II) to not be acting in their ca18 pacity as a pharmacist; 

19 ‘‘(ii) as part of the certification proc20 ess referred to in clause (i), requires such 

21 practitioners— 

22 ‘‘(I) to have the ability to assess 

23 the duration of pregnancy accurately; 

24 ‘‘(II) to have the ability to diag25 nose ectopic pregnancies; 


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1 ‘‘(III) to have the ability to pro2 vide surgical intervention in cases of 

3 incomplete abortion or severe bleed4 ing; 

5 ‘‘(IV) to have the ability to en6 sure patient access to medical facili7 ties equipped to provide blood trans8 fusions and resuscitation, if necessary; 

9 and 

10 ‘‘(V) to report any deaths or 

11 other adverse events associated with 

12 the use of such abortion drug to the 

13 Food and Drug Administration and to 

14 the manufacturer of such abortion 

15 drug, identifying the patient by a non16 identifiable reference and the serial 

17 number from each package of such 

18 abortion drug; 

19 ‘‘(iii) limits the dispensing of such 

20 abortion drug to patients— 

21 ‘‘(I) in a clinic, medical office, or 

22 hospital by means of in-person admin23 istration by the prescribing health 

24 care practitioner; and 


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1 ‘‘(II) not in pharmacies or any 

2 setting other than the health care set3 tings described in subclause (I); 

4 ‘‘(iv) requires the prescribing health 

5 care practitioner to give to the patient doc6 umentation on any risk of serious com7 plications associated with use of such abor8 tion drug and receive acknowledgment of 

9 such receipt from the patient; 

10 ‘‘(v) requires all known adverse events 

11 associated with such abortion drug to be 

12 reported, excluding any individually identi13 fiable patient information, to the Food and 

14 Drug Administration by the— 

15 ‘‘(I) manufacturers of such abor16 tion drug; and 

17 ‘‘(II) prescribers of such abortion 

18 drug; and 

19 ‘‘(vi) requires reporting of administra20 tion of the abortion drug as required by 

21 State law, or in the absence of a State law 

22 regarding such reporting, in the same 

23 manner as a surgical abortion. 

24 ‘‘(3) REPORTING ON ADVERSE EVENTS BY

25 OTHER HEALTH CARE PRACTITIONERS.—The SecVerDate Sep 11 2014 21:44 Sep 20, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4399.IH H4399

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1 retary shall require all other health care practi2 tioners to report to the Food and Drug Administra3 tion any adverse events experienced by their patients 

4 that are connected to use of an abortion drug, ex5 cluding any individually identifiable patient informa6 tion. 

7 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

8 this section shall be construed to restrict the author9 ity of the Secretary, or of a State, to establish, im10 plement, and enforce requirements and restrictions 

11 with respect to abortion drugs under provisions of 

12 law other than this section that are in addition to 

13 the requirements and restrictions under this 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 la19 beled)— 

20 ‘‘(i) to intentionally kill the unborn 

21 child of a woman known to be pregnant; or 

22 ‘‘(ii) to intentionally terminate the 

23 pregnancy of a woman known to be preg24 nant, with an intention other than— 

25 ‘‘(I) to produce a live birth; or 


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1 ‘‘(II) to remove a dead unborn 

2 child. 

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 trans9 fusion. 

10 ‘‘(v) An infection, including endo11 metritis, pelvic inflammatory disease, and 

12 pelvic infections with sepsis. 

13 ‘‘(vi) A severe infection. 

14 ‘‘(C) The term ‘gestation’ means the pe15 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, reg19 istered, or otherwise permitted, by the United 

20 States or the jurisdiction in which the indi21 vidual practices, to prescribe drugs subject to 

22 section 503(b)(1). 

23 ‘‘(E) The term ‘unborn child’ means an in24 dividual organism of the species homo sapiens, 

25 beginning at fertilization, until the point of 


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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 investiga5 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. 

Æ 


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