SAVE Moms and Babies Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 554 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 28, 2021 Mr. LATTA (for himself, Mr. MOONEY, Mr. BIGGS, Mr. HARRIS, Mrs. WAG- NER, Mr. GONZALEZ of Ohio, Mrs. HINSON, Mr. MOORE of Alabama, Mr. LUETKEMEYER, Mr. GOOD of Virginia, Mr. WENSTRUP, Mr. BABIN, Mr. WESTERMAN, Mrs. RODGERS of Washington, Mr. ROY, Mr. SMITH of New Jersey, Mr. BISHOP of North Carolina, Mr. LAHOOD, Mr. KUSTOFF, Mr. VALADAO, Mrs. LESKO, Mr. LAMALFA, Mr. LAMBORN, Mr. JOHNSON of South Dakota, Mr. GROTHMAN, Mr. STEUBE, Mr. RESCHENTHALER, Mr. LATURNER, Mr. DUNCAN, Mr. CARL, Mr. BAIRD, Mr. BANKS, Mr. JORDAN, Mr. ARRINGTON, Mr. WILSON of South Caro- lina, Mr. CURTIS, Mr. JOYCE of Pennsylvania, Mr. ROSE, Mr. BUCSHON, Mrs. BOEBERT, Mr. ROSENDALE, Mr. BURGESS, Mr. GUEST, Mr. WALTZ, Mr. BOST, Mr. JOHNSON of Louisiana, Mr. DUNN, Mr. MCHENRY, Mr. SESSIONS, Mr. NORMAN, Mr. FEENSTRA, Mr. WEBER of Texas, Mr. ALLEN, Mr. WITTMAN, Mr. WILLIAMS of Texas, Mr. BUDD, Mr. WALBERG, Mr. RICE of South Carolina, Mr. MANN, Mr. KELLY of Mississippi, Mr. TAYLOR, Mr. DAVIDSON, Ms. HERRELL, Mrs. FISCHBACH, Mr. CARTER of Georgia, Mr. HICE of Georgia, Mr. HUIZENGA, Mr. BROOKS, Mr. STEIL, Mr. MAST, Mr. JACKSON, Mr. HERN, and Mr. TONY GONZALES of Texas) 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 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 554 IH 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Support And Value 4 Expectant Moms and Babies Act of 2021’’ or the ‘‘SAVE 5 Moms and Babies Act of 2021’’. 6 SEC. 2. ABORTION DRUGS PROHIBITED. 7 (a) IN GENERAL.—Section 505 of the Federal Food, 8 Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 9 adding at the end the following: 10 ‘‘(z) ABORTION DRUGS.— 11 ‘‘(1) PROHIBITIONS.—The Secretary shall not 12 approve— 13 ‘‘(A) any application submitted under sub- 14 section (b) or (j) for marketing an abortion 15 drug; or 16 ‘‘(B) grant an investigational use exemp- 17 tion under subsection (i) for— 18 ‘‘(i) an abortion drug; or 19 ‘‘(ii) any investigation in which the 20 human embryo or human fetus of a woman 21 known to be pregnant is knowingly de- 22 stroyed. 23 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 554 IH ‘‘(2) PREVIOUSLY APPROVED ABORTION 1 DRUGS.—If an approval described in paragraph (1) 2 is in effect for an abortion drug as of the date of 3 enactment of the Support And Value Expectant 4 Moms and Babies Act of 2021, the Secretary shall— 5 ‘‘(A) not approve any labeling change— 6 ‘‘(i) to approve the use of such abor- 7 tion drug after 70 days gestation; or 8 ‘‘(ii) to approve the dispensing of such 9 abortion drug by any means other than in- 10 person administration by the prescribing 11 health care practitioner; 12 ‘‘(B) treat such abortion drug as subject to 13 section 503(b)(1); and 14 ‘‘(C) require such abortion drug to be sub- 15 ject to a risk evaluation and mitigation strategy 16 under section 505–1 that at a minimum— 17 ‘‘(i) requires health care practitioners 18 who prescribe such abortion drug— 19 ‘‘(I) to be certified in accordance 20 with the strategy; and 21 ‘‘(II) to not be acting in their ca- 22 pacity as a pharmacist; 23 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 554 IH ‘‘(ii) as part of the certification proc- 1 ess referred to in clause (i), requires such 2 practitioners— 3 ‘‘(I) to have the ability to assess 4 the duration of pregnancy accurately; 5 ‘‘(II) to have the ability to diag- 6 nose ectopic pregnancies; 7 ‘‘(III) to have the ability to pro- 8 vide surgical intervention in cases of 9 incomplete abortion or severe bleed- 10 ing; 11 ‘‘(IV) to have the ability to en- 12 sure patient access to medical facili- 13 ties equipped to provide blood trans- 14 fusions and resuscitation, if necessary; 15 and 16 ‘‘(V) to report any deaths or 17 other adverse events associated with 18 the use of such abortion drug to the 19 Food and Drug Administration and to 20 the manufacturer of such abortion 21 drug, identifying the patient by a non- 22 identifiable reference and the serial 23 number from each package of such 24 abortion drug; 25 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 554 IH ‘‘(iii) limits the dispensing of such 1 abortion drug to patients— 2 ‘‘(I) in a clinic, medical office, or 3 hospital by means of in-person admin- 4 istration by the prescribing health 5 care practitioner; and 6 ‘‘(II) not in pharmacies or any 7 setting other than the health care set- 8 tings described in subclause (I); 9 ‘‘(iv) requires the prescribing health 10 care practitioner to give to the patient doc- 11 umentation on any risk of serious com- 12 plications associated with use of such abor- 13 tion drug and receive acknowledgment of 14 such receipt from the patient; 15 ‘‘(v) requires all known adverse events 16 associated with such abortion drug to be 17 reported, excluding any individually identi- 18 fiable patient information, to the Food and 19 Drug Administration by the— 20 ‘‘(I) manufacturers of such abor- 21 tion drug; and 22 ‘‘(II) prescribers of such abortion 23 drug; and 24 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 554 IH ‘‘(vi) requires reporting of administra- 1 tion of the abortion drug as required by 2 State law, or in the absence of a State law 3 regarding such reporting, in the same 4 manner as a surgical abortion. 5 ‘‘(3) REPORTING ON ADVERSE EVENTS BY 6 OTHER HEALTH CARE PRACTITIONERS.—The Sec- 7 retary shall require all other health care practi- 8 tioners to report to the Food and Drug Administra- 9 tion any adverse events experienced by their patients 10 that are connected to use of an abortion drug, ex- 11 cluding any individually identifiable patient informa- 12 tion. 13 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 14 this section shall be construed to restrict the author- 15 ity of the Secretary, or of a State, to establish, im- 16 plement, and enforce requirements and restrictions 17 with respect to abortion drugs under provisions of 18 law other than this section that are in addition to 19 the requirements and restrictions under this section. 20 ‘‘(5) DEFINITIONS.—In this section: 21 ‘‘(A) The term ‘abortion drug’ means any 22 drug, substance, or combination of drugs or 23 substances that is intended for use or that is in 24 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 554 IH fact used (irrespective of how the product is la- 1 beled)— 2 ‘‘(i) to intentionally kill the unborn 3 child of a woman known to be pregnant; or 4 ‘‘(ii) to intentionally terminate the 5 pregnancy of a woman known to be preg- 6 nant, with an intention other than— 7 ‘‘(I) to produce a live birth; or 8 ‘‘(II) to remove a dead unborn 9 child. 10 ‘‘(B) The term ‘adverse event’ includes 11 each of the following: 12 ‘‘(i) A fatality. 13 ‘‘(ii) An ectopic pregnancy. 14 ‘‘(iii) A hospitalization. 15 ‘‘(iv) A blood loss requiring a trans- 16 fusion. 17 ‘‘(v) An infection, including endo- 18 metritis, pelvic inflammatory disease, and 19 pelvic infections with sepsis. 20 ‘‘(vi) A severe infection. 21 ‘‘(C) The term ‘gestation’ means the pe- 22 riod of days beginning on the first day of the 23 last menstrual period. 24 VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 554 IH ‘‘(D) The term ‘health care practitioner’ 1 means any individual who is licensed, reg- 2 istered, or otherwise permitted, by the United 3 States or the jurisdiction in which the indi- 4 vidual practices, to prescribe drugs subject to 5 section 503(b)(1). 6 ‘‘(E) The term ‘unborn child’ means an in- 7 dividual organism of the species homo sapiens, 8 beginning at fertilization, until the point of 9 being born alive as defined in section 8(b) of 10 title 1, United States Code.’’. 11 (b) ONGOING INVESTIGATIONAL USE.—In the case of 12 any investigational use of a drug pursuant to an investiga- 13 tional use exemption under section 505(i) of the Federal 14 Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) that 15 was granted before the date of enactment of this Act, such 16 exemption is deemed to be rescinded as of the day that 17 is 3 years after the date of enactment of this Act if the 18 Secretary would be prohibited by section 505(z)(1)(B) of 19 the Federal Food, Drug, and Cosmetic Act, as added by 20 subsection (a), from granting such exemption as of such 21 day. 22 Æ VerDate Sep 11 2014 02:46 Feb 18, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H554.IH H554 kjohnson on DSK79L0C42PROD with BILLS