[Congressional Record Volume 168, Number 37 (Tuesday, March 1, 2022)]
[Senate]
[Pages S887-S888]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 4935. Mrs. HYDE-SMITH submitted an amendment intended to be 
proposed by her to the bill H.R. 3076, to provide stability to and 
enhance the services of the United States Postal Service, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end, add the following:

                     TITLE IV--SAVE MOMS AND BABIES

     SEC. 401. 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 this subsection, 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--

[[Page S888]]

       ``(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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