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 pre-
scribing and related adverse events, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safeguarding Women’s 
and Children’s Health Act of 2022’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
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(1) Many data limitations affect the accuracy of 
statistics related to chemical abortions in the United 
States, and there is no central database tracking 
this information. 
(2) States may voluntarily choose to share abor-
tion data with the Centers for Disease Control and 
Prevention (CDC), but the Guttmacher Institute, 
which directly surveys abortion providers, consist-
ently documents 30 to 40 percent more abortions 
than the CDC. 
(3) Some States with high volumes of abortion, 
such as California, do not report to the CDC. 
(4) Only 28 States require abortion providers to 
report complications, but there is rarely an enforced 
penalty for noncompliance. Only 12 States require 
other physicians, coroners, or emergency rooms to 
report complications or deaths for investigation, and 
frequently these facilities and physicians are un-
aware of these reporting requirements. 
(5) These data problems are a significant limi-
tation to United States studies on abortion complica-
tions. 
(6) Women experiencing complications will 
often present to an emergency room rather than re-
turn to the abortion provider, and researchers fre-
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quently ignore the difficulty in obtaining accurate 
International Classification of Diseases coding in 
emergency rooms due to search engine failure to dis-
cover induced abortion codes, which leads to 
miscoding and frequently attributing induced abor-
tion complications to spontaneous abortions. 
(7) When compared to surgical abortions, chem-
ical abortions are over 50 percent more likely to re-
sult in an abortion-related visit to an emergency 
room, and by 2015, 60 percent of chemical abortion- 
related emergency room visits were incorrectly coded 
as miscarriages. 
(8) Better quality, international records-link-
ages studies, and meta-analyses document far higher 
rates of complications and mortality from abortion, 
casting doubt on the validity of the reported data by 
which United States public health decisions are 
made. 
(9) Independent systematic analysis of adverse 
event reports submitted to the Food and Drug Ad-
ministration (FDA) between 2000 and 2019 re-
vealed approximately 3,000 United States adverse 
events out of an expected 185,000 adverse events 
based on the known and published complication rate 
after mifepristone misoprostol abortions. Thus, the 
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Adverse Event Reporting System of the FDA cap-
tured only 1.7 percent of the actual adverse events 
occurring in United States women, the majority of 
which occurred prior to 2016 when mifepristone pre-
scribers were required to report adverse events as 
part of the risk evaluation and mitigation strategy. 
(10) In 2016, the FDA relaxed the gestational 
age dispensing from a limitation of 7 weeks gesta-
tion to a limitation of 10 weeks gestation, and at the 
same time the FDA no longer required mifepristone 
prescribers to report adverse events other than 
death. These simultaneous changes ensured that 
there would be no way to capture the increased ad-
verse events resulting from the relaxation of the ges-
tational age requirements. 
(11) In order to fulfil the statutory requirement 
of the FDA to oversee and evaluate the safety of 
mifepristone use as an abortifacient, substantial 
changes 
in 
the 
adverse 
event 
reporting 
for 
mifepristone must be implemented to obtain an ac-
curate evaluation of the impact of mifepristone-re-
lated adverse events on United States women. 
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SEC. 3. ACCURATE REPORTING ON CHEMICAL ABORTION 
AND RELATED ADVERSE EVENTS. 
(a) REPORTING REQUIREMENTS.—The Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall require any abortion drug, 
including any abortion drug approved by the Food and 
Drug Administration before the date of enactment of this 
Act, to have a risk evaluation and mitigation strategy re-
quiring that— 
(1) within 15 days of becoming aware of any 
death or other adverse event in a patient associated 
with the use of such abortion drug, a health care 
provider shall— 
(A) report such death or adverse event to 
the Food and Drug Administration and to the 
manufacturer of such abortion drug; and 
(B) identify in such reporting the patient 
by a nonidentifiable reference and the serial 
number from each package of such abortion 
drug if available; and 
(2) a health care practitioner who prescribes, 
dispenses, or administers such abortion drug shall— 
(A) within 15 days of such prescribing, 
dispensing, or administering, report the action 
to the Food and Drug Administration and the 
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Centers for Disease Control and Prevention; 
and 
(B) exclude from such reporting any indi-
vidually identifiable patient information. 
(b) PORTALS.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall— 
(1) establish and maintain an online portal that 
allows health care practitioners to easily, confiden-
tially, and securely report to the Food and Drug Ad-
ministration and the Centers for Disease Control 
and Prevention by means of online transmission the 
information required by subsection (a) to be re-
ported; and 
(2) establish and maintain an online portal that 
allows patients to easily, confidentially, and securely 
self-report to the Food and Drug Administration 
and the Centers for Disease Control and Prevention 
by means of online transmission any adverse events 
the patients have experienced that are associated 
with use of an abortion drug. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘abortion drug’’ means any drug, 
substance, or combination of drugs or substances 
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that is intended for use or that is in fact used (irre-
spective of how the product is labeled)— 
(A) to intentionally kill the unborn child of 
a woman known to be pregnant; or 
(B) to intentionally terminate the preg-
nancy of a woman known to be pregnant, with 
an intention other than— 
(i) to produce a live birth; 
(ii) to remove a dead unborn child; or 
(iii) to treat an ectopic or molar preg-
nancy. 
(2) The term ‘‘adverse event’’ means any unto-
ward medical occurrence associated with the use of 
a drug in humans, whether or not considered drug- 
related. 
(3) The term ‘‘unborn child’’ means an indi-
vidual organism of the species homo sapiens, begin-
ning at fertilization, until the point of being born 
alive as defined in section 8(b) of title 1, United 
States Code. 
SEC. 4. IMPROVED REPORTING OF DATA RELATED TO 
CHEMICAL ABORTIONS. 
The Public Health Service Act is amended by insert-
ing after section 317U of such Act (42 U.S.C. 247b–23) 
the following: 
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‘‘SEC. 317V. IMPROVED REPORTING OF DATA RELATED TO 
CHEMICAL ABORTIONS. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall— 
‘‘(1) collect and aggregate in a standardized 
format information that is reported pursuant to sec-
tion 3 of the Safeguarding Women’s and Children’s 
Health Act of 2022 with respect to abortion drugs; 
‘‘(2) make such information available in accord-
ance with section 552 of title 5, United States Code; 
and 
‘‘(3) annually publish— 
‘‘(A) the number of abortion drugs pre-
scribed in the United States; 
‘‘(B) the number of abortion drugs that 
are shipped directly to prescribers and to pa-
tients; 
‘‘(C) the total number of deaths that oc-
curred within 120 days of ingestion of an abor-
tion drug, regardless of causal attribution, and 
the cause of death; 
‘‘(D) the total number of serious adverse 
events that occurred within 120 days of inges-
tion of an abortion drug; 
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‘‘(E) the number of times each such seri-
ous adverse event occurred; 
‘‘(F) the total number of all adverse events 
that occurred within 120 days of ingestion of 
an abortion drug, stratified by the Common 
Terminology for Coding Adverse Events (or any 
successor publication) criteria for severity grad-
ing; and 
‘‘(G) the number of times abortion drug 
ingestion resulted in an incomplete abortion. 
‘‘(b) TECHNICAL ASSISTANCE.—The Secretary shall 
provide technical assistance to facilitate and improve the 
reporting of data for purposes of this section. 
‘‘(c) ANNUAL REPORTING.—The Secretary shall— 
‘‘(1) annually publish a report on the data col-
lected and aggregated pursuant to subsection (a)(1); 
and 
‘‘(2) post such report on the public website of 
the Food and Drug Administration. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘abortion drug’ means any drug, 
substance, or combination of drugs or substances 
that is intended for use or that is in fact used (irre-
spective of how the product is labeled)— 
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‘‘(A) to intentionally kill the unborn child 
of a woman known to be pregnant; or 
‘‘(B) to intentionally terminate the preg-
nancy of a woman known to be pregnant, with 
an intention other than— 
‘‘(i) to produce a live birth; 
‘‘(ii) to remove a dead unborn child; 
or 
‘‘(iii) to treat an ectopic or molar 
pregnancy. 
‘‘(2) The term ‘adverse event’ means any unto-
ward medical occurrence associated with the use of 
a drug in humans, whether or not considered drug- 
related. 
‘‘(3) The term ‘serious adverse event’ means an 
adverse event that meets Common Terminology for 
Coding Adverse Events criteria (or any successor 
publication) for level 3 or above. 
‘‘(4) The term ‘unborn child’ means an indi-
vidual organism of the species homo sapiens, begin-
ning at fertilization, until the point of being born 
alive as defined in section 8(b) of title 1, United 
States Code.’’. 
Æ 
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