Support And Value Expectant Moms and Babies Act of 2019 or the SAVE Moms and Babies Act of 2019
This bill prohibits the Food and Drug Administration (FDA) from approving any new drug (either as a brand-name drug or a generic) intended to terminate a pregnancy and imposes additional restrictions on such drugs that are already approved.
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]
[S. 3072 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 3072
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 SENATE OF THE UNITED STATES
December 17, 2019
Mrs. Hyde-Smith (for herself, Mr. Cramer, Mr. Wicker, Mr. Inhofe, Mr.
Scott of Florida, Mr. Daines, Mr. Cotton, Mr. Sasse, Mr. Lankford, Mr.
Rounds, and Mr. Moran) introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
_______________________________________________________________________
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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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