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 prescribing and related adverse events, 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safeguarding Women’s 

5 and Children’s Health Act of 2023’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) Many data limitations affect the accuracy of 

9 statistics related to chemical abortions in the United 


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1 States, and there is no central database tracking 

2 this information. 

3 (2) States may voluntarily choose to share abor4 tion data with the Centers for Disease Control and 

5 Prevention (CDC), but the Guttmacher Institute, 

6 which directly surveys abortion providers, consist7 ently documents 30 to 40 percent more abortions 

8 than the CDC. 

9 (3) Some States with high volumes of abortion, 

10 such as California, do not report to the CDC. 

11 (4) Only 28 States require abortion providers to 

12 report complications, but there is rarely an enforced 

13 penalty for noncompliance. Only 12 States require 

14 other physicians, coroners, or emergency rooms to 

15 report complications or deaths for investigation, and 

16 frequently these facilities and physicians are un17 aware of these reporting requirements. 

18 (5) These data problems are a significant limi19 tation to United States studies on abortion complica20 tions. 

21 (6) Women experiencing complications will 

22 often present to an emergency room rather than re23 turn to the abortion provider, and researchers fre24 quently ignore the difficulty in obtaining accurate 

25 International Classification of Diseases coding in 


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1 emergency rooms due to search engine failure to dis2 cover induced abortion codes, which leads to 

3 miscoding and frequently attributing induced abor4 tion complications to spontaneous abortions. 

5 (7) When compared to surgical abortions, chem6 ical abortions are over 50 percent more likely to re7 sult in an abortion-related visit to an emergency 

8 room, and by 2015, 60 percent of chemical abortion9 related emergency room visits were incorrectly coded 

10 as miscarriages. 

11 (8) Better quality, international records-link12 ages studies, and meta-analyses document far higher 

13 rates of complications and mortality from abortion, 

14 casting doubt on the validity of the reported data by 

15 which United States public health decisions are 

16 made. 

17 (9) Independent systematic analysis of adverse 

18 event reports submitted to the Food and Drug Ad19 ministration (FDA) between 2000 and 2019 re20 vealed approximately 3,000 United States adverse 

21 events out of an expected 185,000 adverse events 

22 based on the known and published complication rate 

23 after mifepristone misoprostol abortions. Thus, the 

24 Adverse Event Reporting System of the FDA cap25 tured only 1.7 percent of the actual adverse events 


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1 occurring in United States women, the majority of 

2 which occurred prior to 2016 when mifepristone pre3 scribers were required to report adverse events as 

4 part of the risk evaluation and mitigation strategy. 

5 (10) In 2016, the FDA relaxed the gestational 

6 age dispensing from a limitation of 7 weeks gesta7 tion to a limitation of 10 weeks gestation, and at the 

8 same time the FDA no longer required mifepristone 

9 prescribers to report adverse events other than 

10 death. These simultaneous changes ensured that 

11 there would be no way to capture the increased ad12 verse events resulting from the relaxation of the ges13 tational age requirements. 

14 (11) In order to fulfil the statutory requirement 

15 of the FDA to oversee and evaluate the safety of 

16 mifepristone use as an abortifacient, substantial 

17 changes in the adverse event reporting for 

18 mifepristone must be implemented to obtain an ac19 curate evaluation of the impact of mifepristone-re20 lated adverse events on United States women. 

21 SEC. 3. ACCURATE REPORTING ON CHEMICAL ABORTION 

22 AND RELATED ADVERSE EVENTS. 

23 (a) REPORTING REQUIREMENTS.—The Secretary of 

24 Health and Human Services, acting through the Commis25 sioner of Food and Drugs, shall require any abortion drug, 


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1 including any abortion drug approved by the Food and 

2 Drug Administration before the date of enactment of this 

3 Act, to have a risk evaluation and mitigation strategy re4 quiring that— 

5 (1) within 15 days of becoming aware of any 

6 death or other adverse event in a patient associated 

7 with the use of such abortion drug, a health care 

8 provider shall— 

9 (A) report such death or adverse event to 

10 the Food and Drug Administration and to the 

11 manufacturer of such abortion drug; and 

12 (B) identify in such reporting the patient 

13 by a nonidentifiable reference and the serial 

14 number from each package of such abortion 

15 drug if available; and 

16 (2) a health care practitioner who prescribes, 

17 dispenses, or administers such abortion drug shall— 

18 (A) within 15 days of such prescribing, 

19 dispensing, or administering, report the action 

20 to the Food and Drug Administration and the 

21 Centers for Disease Control and Prevention; 

22 and 

23 (B) exclude from such reporting any indi24 vidually identifiable patient information. 


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1 (b) PORTALS.—The Secretary of Health and Human 

2 Services, acting through the Commissioner of Food and 

3 Drugs, shall— 

4 (1) establish and maintain an online portal that 

5 allows health care practitioners to easily, confiden6 tially, and securely report to the Food and Drug Ad7 ministration and the Centers for Disease Control 

8 and Prevention by means of online transmission the 

9 information required by subsection (a) to be re10 ported; and 

11 (2) establish and maintain an online portal that 

12 allows patients to easily, confidentially, and securely 

13 self-report to the Food and Drug Administration 

14 and the Centers for Disease Control and Prevention 

15 by means of online transmission any adverse events 

16 the patients have experienced that are associated 

17 with use of an abortion drug. 

18 (c) DEFINITIONS.—In this section: 

19 (1) The term ‘‘abortion drug’’ means any drug, 

20 substance, or combination of drugs or substances 

21 that is intended for use or that is in fact used (irre22 spective of how the product is labeled)— 

23 (A) to intentionally kill the unborn child of 

24 a woman known to be pregnant; or 


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1 (B) to intentionally terminate the preg2 nancy of a woman known to be pregnant, with 

3 an intention other than— 

4 (i) to produce a live birth; 

5 (ii) to remove a dead unborn child; or 

6 (iii) to treat an ectopic or molar preg7 nancy. 

8 (2) The term ‘‘adverse event’’ means any unto9 ward medical occurrence associated with the use of 

10 a drug in humans, whether or not considered drug11 related. 

12 (3) The term ‘‘unborn child’’ means an indi13 vidual organism of the species homo sapiens, begin14 ning at fertilization, until the point of being born 

15 alive as defined in section 8(b) of title 1, United 

16 States Code. 

17 SEC. 4. IMPROVED REPORTING OF DATA RELATED TO 

18 CHEMICAL ABORTIONS. 

19 The Public Health Service Act is amended by insert20 ing after section 317V of such Act (42 U.S.C. 247b–24) 

21 the following: 


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1 ‘‘SEC. 317W. IMPROVED REPORTING OF DATA RELATED TO 

2 CHEMICAL ABORTIONS. 

3 ‘‘(a) IN GENERAL.—The Secretary, acting through 

4 the Director of the Centers for Disease Control and Pre5 vention, shall— 

6 ‘‘(1) collect and aggregate in a standardized 

7 format information that is reported pursuant to sec8 tion 3 of the Safeguarding Women’s and Children’s 

9 Health Act of 2023 with respect to abortion drugs; 

10 ‘‘(2) make such information available in accord11 ance with section 552 of title 5, United States Code; 

12 and 

13 ‘‘(3) annually publish— 

14 ‘‘(A) the number of abortion drugs pre15 scribed in the United States; 

16 ‘‘(B) the number of abortion drugs that 

17 are shipped directly to prescribers and to pa18 tients; 

19 ‘‘(C) the total number of deaths that oc20 curred within 120 days of ingestion of an abor21 tion drug, regardless of causal attribution, and 

22 the cause of death; 

23 ‘‘(D) the total number of serious adverse 

24 events that occurred within 120 days of inges25 tion of an abortion drug; 


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1 ‘‘(E) the number of times each such seri2 ous adverse event occurred; 

3 ‘‘(F) the total number of all adverse events 

4 that occurred within 120 days of ingestion of 

5 an abortion drug, stratified by the Common 

6 Terminology for Coding Adverse Events (or any 

7 successor publication) criteria for severity grad8 ing; and 

9 ‘‘(G) the number of times abortion drug 

10 ingestion resulted in an incomplete abortion. 

11 ‘‘(b) TECHNICAL ASSISTANCE.—The Secretary shall 

12 provide technical assistance to facilitate and improve the 

13 reporting of data for purposes of this section. 

14 ‘‘(c) ANNUAL REPORTING.—The Secretary shall— 

15 ‘‘(1) annually publish a report on the data col16 lected and aggregated pursuant to subsection (a)(1); 

17 and 

18 ‘‘(2) post such report on the public website of 

19 the Food and Drug Administration. 

20 ‘‘(d) DEFINITIONS.—In this section: 

21 ‘‘(1) The term ‘abortion drug’ means any drug, 

22 substance, or combination of drugs or substances 

23 that is intended for use or that is in fact used (irre24 spective of how the product is labeled)— 


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1 ‘‘(A) to intentionally kill the unborn child 

2 of a woman known to be pregnant; or 

3 ‘‘(B) to intentionally terminate the preg4 nancy of a woman known to be pregnant, with 

5 an intention other than— 

6 ‘‘(i) to produce a live birth; 

7 ‘‘(ii) to remove a dead unborn child; 

8 or 

9 ‘‘(iii) to treat an ectopic or molar 

10 pregnancy. 

11 ‘‘(2) The term ‘adverse event’ means any unto12 ward medical occurrence associated with the use of 

13 a drug in humans, whether or not considered drug14 related. 

15 ‘‘(3) The term ‘serious adverse event’ means an 

16 adverse event that meets Common Terminology for 

17 Coding Adverse Events criteria (or any successor 

18 publication) for level 3 or above. 

19 ‘‘(4) The term ‘unborn child’ means an indi20 vidual organism of the species homo sapiens, begin21 ning at fertilization, until the point of being born 

22 alive as defined in section 8(b) of title 1, United 

23 States Code.’’. 

Æ 


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