Safeguarding Women’s and Children’s Health Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 2570 To require more accurate reporting of abortion drug prescribing and related adverse events, and for other purposes. IN THE HOUSE OF REPRESENTATIVES APRIL 10, 2023 Mr. PFLUGER (for himself and Mr. HUDSON) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require more accurate reporting of abortion drug pre- scribing and related adverse events, and for other pur- poses. 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 ‘‘Safeguarding Women’s 4 and Children’s Health Act of 2023’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 (1) Many data limitations affect the accuracy of 8 statistics related to chemical abortions in the United 9 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2570 IH States, and there is no central database tracking 1 this information. 2 (2) States may voluntarily choose to share abor- 3 tion data with the Centers for Disease Control and 4 Prevention (CDC), but the Guttmacher Institute, 5 which directly surveys abortion providers, consist- 6 ently documents 30 to 40 percent more abortions 7 than the CDC. 8 (3) Some States with high volumes of abortion, 9 such as California, do not report to the CDC. 10 (4) Only 28 States require abortion providers to 11 report complications, but there is rarely an enforced 12 penalty for noncompliance. Only 12 States require 13 other physicians, coroners, or emergency rooms to 14 report complications or deaths for investigation, and 15 frequently these facilities and physicians are un- 16 aware of these reporting requirements. 17 (5) These data problems are a significant limi- 18 tation to United States studies on abortion complica- 19 tions. 20 (6) Women experiencing complications will 21 often present to an emergency room rather than re- 22 turn to the abortion provider, and researchers fre- 23 quently ignore the difficulty in obtaining accurate 24 International Classification of Diseases coding in 25 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2570 IH emergency rooms due to search engine failure to dis- 1 cover induced abortion codes, which leads to 2 miscoding and frequently attributing induced abor- 3 tion complications to spontaneous abortions. 4 (7) When compared to surgical abortions, chem- 5 ical abortions are over 50 percent more likely to re- 6 sult in an abortion-related visit to an emergency 7 room, and by 2015, 60 percent of chemical abortion- 8 related emergency room visits were incorrectly coded 9 as miscarriages. 10 (8) Better quality, international records-link- 11 ages studies, and meta-analyses document far higher 12 rates of complications and mortality from abortion, 13 casting doubt on the validity of the reported data by 14 which United States public health decisions are 15 made. 16 (9) Independent systematic analysis of adverse 17 event reports submitted to the Food and Drug Ad- 18 ministration (FDA) between 2000 and 2019 re- 19 vealed approximately 3,000 United States adverse 20 events out of an expected 185,000 adverse events 21 based on the known and published complication rate 22 after mifepristone misoprostol abortions. Thus, the 23 Adverse Event Reporting System of the FDA cap- 24 tured only 1.7 percent of the actual adverse events 25 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 2570 IH occurring in United States women, the majority of 1 which occurred prior to 2016 when mifepristone pre- 2 scribers were required to report adverse events as 3 part of the risk evaluation and mitigation strategy. 4 (10) In 2016, the FDA relaxed the gestational 5 age dispensing from a limitation of 7 weeks gesta- 6 tion to a limitation of 10 weeks gestation, and at the 7 same time the FDA no longer required mifepristone 8 prescribers to report adverse events other than 9 death. These simultaneous changes ensured that 10 there would be no way to capture the increased ad- 11 verse events resulting from the relaxation of the ges- 12 tational age requirements. 13 (11) In order to fulfil the statutory requirement 14 of the FDA to oversee and evaluate the safety of 15 mifepristone use as an abortifacient, substantial 16 changes in the adverse event reporting for 17 mifepristone must be implemented to obtain an ac- 18 curate evaluation of the impact of mifepristone-re- 19 lated adverse events on United States women. 20 SEC. 3. ACCURATE REPORTING ON CHEMICAL ABORTION 21 AND RELATED ADVERSE EVENTS. 22 (a) REPORTING REQUIREMENTS.—The Secretary of 23 Health and Human Services, acting through the Commis- 24 sioner of Food and Drugs, shall require any abortion drug, 25 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 2570 IH including any abortion drug approved by the Food and 1 Drug Administration before the date of enactment of this 2 Act, to have a risk evaluation and mitigation strategy re- 3 quiring that— 4 (1) within 15 days of becoming aware of any 5 death or other adverse event in a patient associated 6 with the use of such abortion drug, a health care 7 provider shall— 8 (A) report such death or adverse event to 9 the Food and Drug Administration and to the 10 manufacturer of such abortion drug; and 11 (B) identify in such reporting the patient 12 by a nonidentifiable reference and the serial 13 number from each package of such abortion 14 drug if available; and 15 (2) a health care practitioner who prescribes, 16 dispenses, or administers such abortion drug shall— 17 (A) within 15 days of such prescribing, 18 dispensing, or administering, report the action 19 to the Food and Drug Administration and the 20 Centers for Disease Control and Prevention; 21 and 22 (B) exclude from such reporting any indi- 23 vidually identifiable patient information. 24 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 2570 IH (b) PORTALS.—The Secretary of Health and Human 1 Services, acting through the Commissioner of Food and 2 Drugs, shall— 3 (1) establish and maintain an online portal that 4 allows health care practitioners to easily, confiden- 5 tially, and securely report to the Food and Drug Ad- 6 ministration and the Centers for Disease Control 7 and Prevention by means of online transmission the 8 information required by subsection (a) to be re- 9 ported; and 10 (2) establish and maintain an online portal that 11 allows patients to easily, confidentially, and securely 12 self-report to the Food and Drug Administration 13 and the Centers for Disease Control and Prevention 14 by means of online transmission any adverse events 15 the patients have experienced that are associated 16 with use of an abortion drug. 17 (c) DEFINITIONS.—In this section: 18 (1) The term ‘‘abortion drug’’ means any drug, 19 substance, or combination of drugs or substances 20 that is intended for use or that is in fact used (irre- 21 spective of how the product is labeled)— 22 (A) to intentionally kill the unborn child of 23 a woman known to be pregnant; or 24 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 2570 IH (B) to intentionally terminate the preg- 1 nancy of a woman known to be pregnant, with 2 an intention other than— 3 (i) to produce a live birth; 4 (ii) to remove a dead unborn child; or 5 (iii) to treat an ectopic or molar preg- 6 nancy. 7 (2) The term ‘‘adverse event’’ means any unto- 8 ward medical occurrence associated with the use of 9 a drug in humans, whether or not considered drug- 10 related. 11 (3) The term ‘‘unborn child’’ means an indi- 12 vidual organism of the species homo sapiens, begin- 13 ning at fertilization, until the point of being born 14 alive as defined in section 8(b) of title 1, United 15 States Code. 16 SEC. 4. IMPROVED REPORTING OF DATA RELATED TO 17 CHEMICAL ABORTIONS. 18 The Public Health Service Act is amended by insert- 19 ing after section 317V of such Act (42 U.S.C. 247b–24) 20 the following: 21 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 2570 IH ‘‘SEC. 317W. IMPROVED REPORTING OF DATA RELATED TO 1 CHEMICAL ABORTIONS. 2 ‘‘(a) IN GENERAL.—The Secretary, acting through 3 the Director of the Centers for Disease Control and Pre- 4 vention, shall— 5 ‘‘(1) collect and aggregate in a standardized 6 format information that is reported pursuant to sec- 7 tion 3 of the Safeguarding Women’s and Children’s 8 Health Act of 2023 with respect to abortion drugs; 9 ‘‘(2) make such information available in accord- 10 ance with section 552 of title 5, United States Code; 11 and 12 ‘‘(3) annually publish— 13 ‘‘(A) the number of abortion drugs pre- 14 scribed in the United States; 15 ‘‘(B) the number of abortion drugs that 16 are shipped directly to prescribers and to pa- 17 tients; 18 ‘‘(C) the total number of deaths that oc- 19 curred within 120 days of ingestion of an abor- 20 tion drug, regardless of causal attribution, and 21 the cause of death; 22 ‘‘(D) the total number of serious adverse 23 events that occurred within 120 days of inges- 24 tion of an abortion drug; 25 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 2570 IH ‘‘(E) the number of times each such seri- 1 ous adverse event occurred; 2 ‘‘(F) the total number of all adverse events 3 that occurred within 120 days of ingestion of 4 an abortion drug, stratified by the Common 5 Terminology for Coding Adverse Events (or any 6 successor publication) criteria for severity grad- 7 ing; and 8 ‘‘(G) the number of times abortion drug 9 ingestion resulted in an incomplete abortion. 10 ‘‘(b) TECHNICAL ASSISTANCE.—The Secretary shall 11 provide technical assistance to facilitate and improve the 12 reporting of data for purposes of this section. 13 ‘‘(c) ANNUAL REPORTING.—The Secretary shall— 14 ‘‘(1) annually publish a report on the data col- 15 lected and aggregated pursuant to subsection (a)(1); 16 and 17 ‘‘(2) post such report on the public website of 18 the Food and Drug Administration. 19 ‘‘(d) DEFINITIONS.—In this section: 20 ‘‘(1) The term ‘abortion drug’ means any drug, 21 substance, or combination of drugs or substances 22 that is intended for use or that is in fact used (irre- 23 spective of how the product is labeled)— 24 VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 2570 IH ‘‘(A) to intentionally kill the unborn child 1 of a woman known to be pregnant; or 2 ‘‘(B) to intentionally terminate the preg- 3 nancy of a woman known to be pregnant, with 4 an intention other than— 5 ‘‘(i) to produce a live birth; 6 ‘‘(ii) to remove a dead unborn child; 7 or 8 ‘‘(iii) to treat an ectopic or molar 9 pregnancy. 10 ‘‘(2) The term ‘adverse event’ means any unto- 11 ward medical occurrence associated with the use of 12 a drug in humans, whether or not considered drug- 13 related. 14 ‘‘(3) The term ‘serious adverse event’ means an 15 adverse event that meets Common Terminology for 16 Coding Adverse Events criteria (or any successor 17 publication) for level 3 or above. 18 ‘‘(4) The term ‘unborn child’ means an indi- 19 vidual organism of the species homo sapiens, begin- 20 ning at fertilization, until the point of being born 21 alive as defined in section 8(b) of title 1, United 22 States Code.’’. 23 Æ VerDate Sep 11 2014 02:56 Apr 15, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H2570.IH H2570 kjohnson on DSK79L0C42PROD with BILLS