119-hr685

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 685 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 685

 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

 January 23, 2025

 Mr. Latta (for himself, Mr. Rouzer, Mr. Brecheen, Mr. Strong, Mrs. 
Miller of Illinois, Mr. Webster of Florida, Mr. Finstad, Mr. Aderholt, 
 Mr. Feenstra, Mr. Smith of New Jersey, Mr. Fulcher, Mr. Flood, Mr. 
Mann, Mr. Harris of Maryland, Mr. Fong, Mr. Ellzey, Mr. Weber of Texas, 
 Mr. McCormick, Mr. Moolenaar, Mr. Ogles, Mr. Guest, Mr. Higgins of 
Louisiana, Mr. Palmer, Mr. Moore of North Carolina, Mr. Shreve, and Mr. 
 LaHood) 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 2025'' or the ``SAVE Moms and Babies Act of 2025''.

SEC. 2. ABORTION DRUGS PROHIBITED.

    (a) In General.--

Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) (as amended by Public Law 117-328) is 
amended by adding at the end the following:
 ``

    (aa) 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 
 unborn child 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 2025, 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 Federal 
 Government, 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) to 
 intentionally kill the unborn child of a woman known to 
 be pregnant, or 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 pregnancy.
 ``
        (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

    (aa)

    (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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