Safeguarding Women's and Children's Health Act of 2022
This bill imposes reporting requirements relating to abortion drugs.
The Food and Drug Administration (FDA) must require health care practitioners to report (1) any death or adverse event associated with the use of an abortion drug, whether or not the adverse event is considered drug-related; and (2) each time the practitioner prescribes, dispenses, or administers such a drug.
The FDA must establish online portals for health care practitioners to report such information and for patients to self-report adverse events.
The Centers for Disease Control and Prevention must aggregate the collected information and annually publish data about such drugs, including the number of prescriptions and adverse events occurring within 120 days of use.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6702 Introduced in House (IH)]
<DOC>
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.
Be it enacted by the Senate and House of Representatives 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:
(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 abortion data
with the Centers for Disease Control and Prevention (CDC), but
the Guttmacher Institute, which directly surveys abortion
providers, consistently 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 unaware of these reporting requirements.
(5) These data problems are a significant limitation to
United States studies on abortion complications.
(6) Women experiencing complications will often present to
an emergency room rather than return to the abortion provider,
and researchers frequently ignore the difficulty in obtaining
accurate International Classification of Diseases coding in
emergency rooms due to search engine failure to discover
induced abortion codes, which leads to miscoding and frequently
attributing induced abortion complications to spontaneous
abortions.
(7) When compared to surgical abortions, chemical abortions
are over 50 percent more likely to result 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-linkages 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 Administration (FDA)
between 2000 and 2019 revealed 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 Adverse Event
Reporting System of the FDA captured only 1.7 percent of the
actual adverse events occurring in United States women, the
majority of which occurred prior to 2016 when mifepristone
prescribers 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 gestation 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 adverse
events resulting from the relaxation of the gestational 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
accurate evaluation of the impact of mifepristone-related
adverse events on United States women.
SEC. 3. ACCURATE REPORTING ON CHEMICAL ABORTION AND RELATED ADVERSE
EVENTS.
(a) Reporting Requirements.--The Secretary of Health and Human
Services, acting through the Commissioner 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 requiring 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 Centers for Disease Control
and Prevention; and
(B) exclude from such reporting any individually
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, confidentially, and
securely report to the Food and Drug Administration and the
Centers for Disease Control and Prevention by means of online
transmission the information required by subsection (a) to be
reported; 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 that is intended for use
or that is in fact used (irrespective 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 pregnancy 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 untoward medical
occurrence associated with the use of a drug in humans, whether
or not considered drug-related.
(3) The term ``unborn child'' means an individual organism
of the species homo sapiens, beginning 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 inserting after section
317U of such Act (42 U.S.C. 247b-23) the following:
``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 Prevention, shall--
``(1) collect and aggregate in a standardized format
information that is reported pursuant to section 3 of the
Safeguarding Women's and Children's Health Act of 2022 with
respect to abortion drugs;
``(2) make such information available in accordance with
section 552 of title 5, United States Code; and
``(3) annually publish--
``(A) the number of abortion drugs prescribed in
the United States;
``(B) the number of abortion drugs that are shipped
directly to prescribers and to patients;
``(C) the total number of deaths that occurred
within 120 days of ingestion of an abortion drug,
regardless of causal attribution, and the cause of
death;
``(D) the total number of serious adverse events
that occurred within 120 days of ingestion of an
abortion drug;
``(E) the number of times each such serious 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 grading; 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 collected 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 (irrespective 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 pregnancy 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 untoward 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 individual organism
of the species homo sapiens, beginning at fertilization, until
the point of being born alive as defined in section 8(b) of
title 1, United States Code.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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