Title: Safeguarding Women’s and Children’s Health Act of 2022
Policy area: Health

Summary:
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)]

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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.''.
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