[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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