Title: SAVE Moms and Babies Act of 2019
Policy area: Health

Summary:
Support And Value Expectant Moms and Babies Act of 2019 or the SAVE Moms and Babies Act of 2019
Under the bill, an already-approved drug intended to terminate a pregnancy may be dispensed to a patient only with a prescription. Furthermore, the FDA may not approve any labeling change that would authorize (1) using the drug after 70 days of gestation, or (2) dispensing the drug by any means other than in-person administration by the prescribing health care practitioner.
The FDA must also impose additional restrictions on such already-approved drugs, including by (1) requiring the prescribing health care practitioner to receive a special certification, (2) prohibiting the practitioner to also act as the dispensing pharmacist, and (3) requiring the practitioner to have the ability to provide surgical intervention to the patient.
The bill also rescinds any investigational use exemption already granted to such a drug if the bill would have prohibited the FDA from granting the exemption. (Currently, the FDA may grant an exemption to certain market approval requirements if a drug is intended solely for use in safety and effectiveness investigations.)

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4399 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4399

   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the 
    approval of new abortion drugs, to prohibit investigational use 
  exemptions for abortion drugs, and to impose additional regulatory 
 requirements with respect to previously approved abortion drugs, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 19, 2019

    Mr. Latta (for himself, Mrs. Wagner, Mr. Norman, Mr. Olson, Mr. 
Lamborn, Mr. Meadows, Mr. Allen, Mr. Williams, Mr. Smith of New Jersey, 
Mr. Weber of Texas, Mr. Watkins, Mr. Gianforte, Mr. Chabot, Mr. Babin, 
Mr. Ratcliffe, Mr. Loudermilk, Mr. Rutherford, Mr. LaMalfa, Mr. Flores, 
Mr. Kevin Hern of Oklahoma, Mr. Abraham, Mr. Harris, Mrs. Hartzler, Mr. 
    Estes, Mr. Gibbs, Mr. Grothman, Mr. Wittman, Ms. Foxx of North 
  Carolina, Mr. Walberg, and Mr. Higgins of Louisiana) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the 
    approval of new abortion drugs, to prohibit investigational use 
  exemptions for abortion drugs, and to impose additional regulatory 
 requirements with respect to previously approved abortion drugs, 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 ``Support And Value Expectant Moms and 
Babies Act of 2019'' or the ``SAVE Moms and Babies Act of 2019''.

SEC. 2. ABORTION DRUGS PROHIBITED.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the 
following:
    ``(z) Abortion Drugs.--
            ``(1) Prohibitions.--The Secretary shall not approve--
                    ``(A) any application submitted under subsection 
                (b) or (j) for marketing an abortion drug; or
                    ``(B) grant an investigational use exemption under 
                subsection (i) for--
                            ``(i) an abortion drug; or
                            ``(ii) any investigation in which the human 
                        embryo or human fetus of a woman known to be 
                        pregnant is knowingly destroyed.
            ``(2) Previously approved abortion drugs.--If an approval 
        described in paragraph (1) is in effect for an abortion drug as 
        of the date of enactment of the Support And Value Expectant 
        Moms and Babies Act of 2019, the Secretary shall--
                    ``(A) not approve any labeling change--
                            ``(i) to approve the use of such abortion 
                        drug after 70 days gestation; or
                            ``(ii) to approve the dispensing of such 
                        abortion drug by any means other than in-person 
                        administration by the prescribing health care 
                        practitioner;
                    ``(B) treat such abortion drug as subject to 
                section 503(b)(1); and
                    ``(C) require such abortion drug to be subject to a 
                risk evaluation and mitigation strategy under section 
                505-1 that at a minimum--
                            ``(i) requires health care practitioners 
                        who prescribe such abortion drug--
                                    ``(I) to be certified in accordance 
                                with the strategy; and
                                    ``(II) to not be acting in their 
                                capacity as a pharmacist;
                            ``(ii) as part of the certification process 
                        referred to in clause (i), requires such 
                        practitioners--
                                    ``(I) to have the ability to assess 
                                the duration of pregnancy accurately;
                                    ``(II) to have the ability to 
                                diagnose ectopic pregnancies;
                                    ``(III) to have the ability to 
                                provide surgical intervention in cases 
                                of incomplete abortion or severe 
                                bleeding;
                                    ``(IV) to have the ability to 
                                ensure patient access to medical 
                                facilities equipped to provide blood 
                                transfusions and resuscitation, if 
                                necessary; and
                                    ``(V) to report any deaths or other 
                                adverse events associated with the use 
                                of such abortion drug to the Food and 
                                Drug Administration and to the 
                                manufacturer of such abortion drug, 
                                identifying the patient by a non-
                                identifiable reference and the serial 
                                number from each package of such 
                                abortion drug;
                            ``(iii) limits the dispensing of such 
                        abortion drug to patients--
                                    ``(I) in a clinic, medical office, 
                                or hospital by means of in-person 
                                administration by the prescribing 
                                health care practitioner; and
                                    ``(II) not in pharmacies or any 
                                setting other than the health care 
                                settings described in subclause (I);
                            ``(iv) requires the prescribing health care 
                        practitioner to give to the patient 
                        documentation on any risk of serious 
                        complications associated with use of such 
                        abortion drug and receive acknowledgment of 
                        such receipt from the patient;
                            ``(v) requires all known adverse events 
                        associated with such abortion drug to be 
                        reported, excluding any individually 
                        identifiable patient information, to the Food 
                        and Drug Administration by the--
                                    ``(I) manufacturers of such 
                                abortion drug; and
                                    ``(II) prescribers of such abortion 
                                drug; and
                            ``(vi) requires reporting of administration 
                        of the abortion drug as required by State law, 
                        or in the absence of a State law regarding such 
                        reporting, in the same manner as a surgical 
                        abortion.
            ``(3) Reporting on adverse events by other health care 
        practitioners.--The Secretary shall require all other health 
        care practitioners to report to the Food and Drug 
        Administration any adverse events experienced by their patients 
        that are connected to use of an abortion drug, excluding any 
        individually identifiable patient information.
            ``(4) Rule of construction.--Nothing in this section shall 
        be construed to restrict the authority of the Secretary, or of 
        a State, to establish, implement, and enforce requirements and 
        restrictions with respect to abortion drugs under provisions of 
        law other than this section that are in addition to the 
        requirements and restrictions under this section.
            ``(5) Definitions.--In this section:
                    ``(A) 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)--
                            ``(i) to intentionally kill the unborn 
                        child of a woman known to be pregnant; or
                            ``(ii) to intentionally terminate the 
                        pregnancy of a woman known to be pregnant, with 
                        an intention other than--
                                    ``(I) to produce a live birth; or
                                    ``(II) to remove a dead unborn 
                                child.
                    ``(B) The term `adverse event' includes each of the 
                following:
                            ``(i) A fatality.
                            ``(ii) An ectopic pregnancy.
                            ``(iii) A hospitalization.
                            ``(iv) A blood loss requiring a 
                        transfusion.
                            ``(v) An infection, including endometritis, 
                        pelvic inflammatory disease, and pelvic 
                        infections with sepsis.
                            ``(vi) A severe infection.
                    ``(C) The term `gestation' means the period of days 
                beginning on the first day of the last menstrual 
                period.
                    ``(D) The term `health care practitioner' means any 
                individual who is licensed, registered, or otherwise 
                permitted, by the United States or the jurisdiction in 
                which the individual practices, to prescribe drugs 
                subject to section 503(b)(1).
                    ``(E) 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.''.
    (b) Ongoing Investigational Use.--In the case of any 
investigational use of a drug pursuant to an investigational use 
exemption under section 505(i) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(i)) that was granted before the date of enactment of 
this Act, such exemption is deemed to be rescinded as of the day that 
is 3 years after the date of enactment of this Act if the Secretary 
would be prohibited by section 505(z)(1)(B) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), from granting such 
exemption as of such day.
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