SAVE Moms and Babies Act of 2019

II 116TH CONGRESS 1ST SESSION S. 3072 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 SENATE OF THE UNITED STATES DECEMBER 17, 2019 Mrs. HYDE-SMITH (for herself, Mr. CRAMER, Mr. WICKER, Mr. INHOFE, Mr. SCOTT of Florida, Mr. DAINES, Mr. COTTON, Mr. SASSE, Mr. LANKFORD, Mr. ROUNDS, and Mr. MORAN) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions 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 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 3072 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Support And Value 2 Expectant Moms and Babies Act of 2019’’ or the ‘‘SAVE 3 Moms and Babies Act of 2019’’. 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) is amended by 7 adding at the end the following: 8 ‘‘(z) ABORTION DRUGS.— 9 ‘‘(1) PROHIBITIONS.—The Secretary shall not 10 approve— 11 ‘‘(A) any application submitted under sub- 12 section (b) or (j) for marketing an abortion 13 drug; or 14 ‘‘(B) grant an investigational use exemp- 15 tion under subsection (i) for— 16 ‘‘(i) an abortion drug; or 17 ‘‘(ii) any investigation in which the 18 human embryo or human fetus of a woman 19 known to be pregnant is knowingly de- 20 stroyed. 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 2019, the Secretary shall— 26 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 3072 IS ‘‘(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 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 3072 IS ‘‘(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 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 3072 IS ‘‘(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 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 3072 IS 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 Secretary, or of a State, to establish, im- 9 plement, and enforce requirements and restrictions 10 with respect to abortion drugs under provisions of 11 law other than this section that are in addition to 12 the requirements and restrictions under this section. 13 ‘‘(5) DEFINITIONS.—In this section: 14 ‘‘(A) The term ‘abortion drug’ means any 15 drug, substance, or combination of drugs or 16 substances that is intended for use or that is in 17 fact used (irrespective of how the product is la- 18 beled)— 19 ‘‘(i) to intentionally kill the unborn 20 child of a woman known to be pregnant; or 21 ‘‘(ii) to intentionally terminate the 22 pregnancy of a woman known to be preg- 23 nant, with an intention other than— 24 ‘‘(I) to produce a live birth; or 25 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 3072 IS ‘‘(II) to remove a dead unborn 1 child. 2 ‘‘(B) The term ‘adverse event’ includes 3 each of the following: 4 ‘‘(i) A fatality. 5 ‘‘(ii) An ectopic pregnancy. 6 ‘‘(iii) A hospitalization. 7 ‘‘(iv) A blood loss requiring a trans- 8 fusion. 9 ‘‘(v) An infection, including endo- 10 metritis, pelvic inflammatory disease, and 11 pelvic infections with sepsis. 12 ‘‘(vi) A severe infection. 13 ‘‘(C) The term ‘gestation’ means the pe- 14 riod of days beginning on the first day of the 15 last menstrual period. 16 ‘‘(D) The term ‘health care practitioner’ 17 means any individual who is licensed, reg- 18 istered, or otherwise permitted, by the United 19 States or the jurisdiction in which the indi- 20 vidual practices, to prescribe drugs subject to 21 section 503(b)(1). 22 ‘‘(E) The term ‘unborn child’ means an in- 23 dividual organism of the species homo sapiens, 24 beginning at fertilization, until the point of 25 VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 3072 IS being born alive as defined in section 8(b) of 1 title 1, United States Code.’’. 2 (b) ONGOING INVESTIGATIONAL USE.—In the case of 3 any investigational use of a drug pursuant to an investiga- 4 tional use exemption under section 505(i) of the Federal 5 Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) that 6 was granted before the date of enactment of this Act, such 7 exemption is deemed to be rescinded as of the day that 8 is 3 years after the date of enactment of this Act if the 9 Secretary would be prohibited by section 505(z)(1)(B) of 10 the Federal Food, Drug, and Cosmetic Act, as added by 11 subsection (a), from granting such exemption as of such 12 day. 13 Æ VerDate Sep 11 2014 00:31 Dec 24, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\S3072.IS S3072 pamtmann on DSKBC07HB2PROD with BILLS