I 

117TH CONGRESS 

2D SESSION H. R. 6702 

To require more accurate reporting of abortion drug prescribing and related 

adverse events, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 9, 2022 

Mrs. WALORSKI (for herself, Mr. MCKINLEY, Mr. LONG, Mr. DUNCAN, Mr. 

BANKS, Mr. MOONEY, Mr. LAMBORN, Mr. CURTIS, Mr. HUDSON, Mr. 

ELLZEY, Mr. BABIN, Mrs. MILLER-MEEKS, Ms. FOXX, Mr. BURCHETT, 

Mr. BURGESS, Mr. FEENSTRA, Mr. JOYCE of Pennsylvania, Mr. 

LAMALFA, Mr. C. SCOTT FRANKLIN of Florida, Mrs. FISCHBACH, and 

Mr. LUETKEMEYER) 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 2022’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 


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1 (1) Many data limitations affect the accuracy of 

2 statistics related to chemical abortions in the United 

3 States, and there is no central database tracking 

4 this information. 

5 (2) States may voluntarily choose to share abor6 tion data with the Centers for Disease Control and 

7 Prevention (CDC), but the Guttmacher Institute, 

8 which directly surveys abortion providers, consist9 ently documents 30 to 40 percent more abortions 

10 than the CDC. 

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

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

13 (4) Only 28 States require abortion providers to 

14 report complications, but there is rarely an enforced 

15 penalty for noncompliance. Only 12 States require 

16 other physicians, coroners, or emergency rooms to 

17 report complications or deaths for investigation, and 

18 frequently these facilities and physicians are un19 aware of these reporting requirements. 

20 (5) These data problems are a significant limi21 tation to United States studies on abortion complica22 tions. 

23 (6) Women experiencing complications will 

24 often present to an emergency room rather than re25 turn to the abortion provider, and researchers freVerDate Sep 11 2014 02:21 Feb 17, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6702.IH H6702

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1 quently ignore the difficulty in obtaining accurate 

2 International Classification of Diseases coding in 

3 emergency rooms due to search engine failure to dis4 cover induced abortion codes, which leads to 

5 miscoding and frequently attributing induced abor6 tion complications to spontaneous abortions. 

7 (7) When compared to surgical abortions, chem8 ical abortions are over 50 percent more likely to re9 sult in an abortion-related visit to an emergency 

10 room, and by 2015, 60 percent of chemical abortion11 related emergency room visits were incorrectly coded 

12 as miscarriages. 

13 (8) Better quality, international records-link14 ages studies, and meta-analyses document far higher 

15 rates of complications and mortality from abortion, 

16 casting doubt on the validity of the reported data by 

17 which United States public health decisions are 

18 made. 

19 (9) Independent systematic analysis of adverse 

20 event reports submitted to the Food and Drug Ad21 ministration (FDA) between 2000 and 2019 re22 vealed approximately 3,000 United States adverse 

23 events out of an expected 185,000 adverse events 

24 based on the known and published complication rate 

25 after mifepristone misoprostol abortions. Thus, the 


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1 Adverse Event Reporting System of the FDA cap2 tured only 1.7 percent of the actual adverse events 

3 occurring in United States women, the majority of 

4 which occurred prior to 2016 when mifepristone pre5 scribers were required to report adverse events as 

6 part of the risk evaluation and mitigation strategy. 

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

8 age dispensing from a limitation of 7 weeks gesta9 tion to a limitation of 10 weeks gestation, and at the 

10 same time the FDA no longer required mifepristone 

11 prescribers to report adverse events other than 

12 death. These simultaneous changes ensured that 

13 there would be no way to capture the increased ad14 verse events resulting from the relaxation of the ges15 tational age requirements. 

16 (11) In order to fulfil the statutory requirement 

17 of the FDA to oversee and evaluate the safety of 

18 mifepristone use as an abortifacient, substantial 

19 changes in the adverse event reporting for 

20 mifepristone must be implemented to obtain an ac21 curate evaluation of the impact of mifepristone-re22 lated adverse events on United States women. 


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1 SEC. 3. ACCURATE REPORTING ON CHEMICAL ABORTION 

2 AND RELATED ADVERSE EVENTS. 

3 (a) REPORTING REQUIREMENTS.—The Secretary of 

4 Health and Human Services, acting through the Commis5 sioner of Food and Drugs, shall require any abortion drug, 

6 including any abortion drug approved by the Food and 

7 Drug Administration before the date of enactment of this 

8 Act, to have a risk evaluation and mitigation strategy re9 quiring that— 

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

11 death or other adverse event in a patient associated 

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

13 provider shall— 

14 (A) report such death or adverse event to 

15 the Food and Drug Administration and to the 

16 manufacturer of such abortion drug; and 

17 (B) identify in such reporting the patient 

18 by a nonidentifiable reference and the serial 

19 number from each package of such abortion 

20 drug if available; and 

21 (2) a health care practitioner who prescribes, 

22 dispenses, or administers such abortion drug shall— 

23 (A) within 15 days of such prescribing, 

24 dispensing, or administering, report the action 

25 to the Food and Drug Administration and the 


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1 Centers for Disease Control and Prevention; 

2 and 

3 (B) exclude from such reporting any indi4 vidually identifiable patient information. 

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

6 Services, acting through the Commissioner of Food and 

7 Drugs, shall— 

8 (1) establish and maintain an online portal that 

9 allows health care practitioners to easily, confiden10 tially, and securely report to the Food and Drug Ad11 ministration and the Centers for Disease Control 

12 and Prevention by means of online transmission the 

13 information required by subsection (a) to be re14 ported; and 

15 (2) establish and maintain an online portal that 

16 allows patients to easily, confidentially, and securely 

17 self-report to the Food and Drug Administration 

18 and the Centers for Disease Control and Prevention 

19 by means of online transmission any adverse events 

20 the patients have experienced that are associated 

21 with use of an abortion drug. 

22 (c) DEFINITIONS.—In this section: 

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

24 substance, or combination of drugs or substances 


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1 that is intended for use or that is in fact used (irre2 spective of how the product is labeled)— 

3 (A) to intentionally kill the unborn child of 

4 a woman known to be pregnant; or 

5 (B) to intentionally terminate the preg6 nancy of a woman known to be pregnant, with 

7 an intention other than— 

8 (i) to produce a live birth; 

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

10 (iii) to treat an ectopic or molar preg11 nancy. 

12 (2) The term ‘‘adverse event’’ means any unto13 ward medical occurrence associated with the use of 

14 a drug in humans, whether or not considered drug15 related. 

16 (3) The term ‘‘unborn child’’ means an indi17 vidual organism of the species homo sapiens, begin18 ning at fertilization, until the point of being born 

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

20 States Code. 

21 SEC. 4. IMPROVED REPORTING OF DATA RELATED TO 

22 CHEMICAL ABORTIONS. 

23 The Public Health Service Act is amended by insert24 ing after section 317U of such Act (42 U.S.C. 247b–23) 

25 the following: 


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1 ‘‘SEC. 317V. 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 2022 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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