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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. Res. 510 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
S. RES. 510

Expressing the sense of the Senate that the scientific judgment of the 
 Food and Drug Administration that mifepristone is safe and effective 
should be respected, and law and policy governing access to lifesaving, 
time-sensitive medication abortion care in the United States should be 
                    equitable and based on science.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           December 14, 2023

Ms. Warren (for herself, Ms. Baldwin, Mr. Blumenthal, Mr. Schumer, Mr. 
    Heinrich, Mr. Merkley, Mr. Padilla, Ms. Hirono, Mr. Brown, Mr. 
 Hickenlooper, Ms. Stabenow, Mr. Bennet, Ms. Duckworth, Ms. Cantwell, 
 Mrs. Shaheen, Mr. Van Hollen, Mr. King, Mr. Wyden, Mr. Fetterman, Ms. 
 Butler, Mr. Reed, Mr. Carper, Ms. Cortez Masto, Mr. Welch, Ms. Rosen, 
Mr. Murphy, Ms. Sinema, Mr. Sanders, Mr. Menendez, Mrs. Gillibrand, Ms. 
 Smith, Mr. Schatz, Mr. Kelly, Mr. Markey, Ms. Hassan, Mr. Whitehouse, 
 Mr. Warnock, Mr. Durbin, Mr. Booker, and Ms. Klobuchar) submitted the 
 following resolution; which was referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                               RESOLUTION

 
Expressing the sense of the Senate that the scientific judgment of the 
 Food and Drug Administration that mifepristone is safe and effective 
should be respected, and law and policy governing access to lifesaving, 
time-sensitive medication abortion care in the United States should be 
                    equitable and based on science.

Whereas Congress, by enacting the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 301 et seq.), authorized the Food and Drug Administration 
        (referred to in this preamble as the ``FDA'') to determine, based on the 
        scientific expertise of the FDA, whether a drug is safe and effective 
        for the intended use of the drug;
Whereas mifepristone is a medication that can be used to terminate a pregnancy;
Whereas mifepristone received approval from the FDA more than 20 years ago, and 
        according to the FDA, the ``efficacy and safety [of mifepristone] have 
        become well-established by both research and experience, and serious 
        complications have proven to be extremely rare'';
Whereas the FDA approved mifepristone following a rigorous 54-month review 
        period that included the review of 3 complete phases of clinical trials 
        that involved thousands of participants and whose data showed that 
        mifepristone was safe and effective for termination of an early 
        pregnancy;
Whereas, in January 2023, after extensive evidence-based review, the FDA 
        approved a modification to the Mifepristone Risk Evaluation and 
        Mitigation Strategy that removed the in-person dispensing requirement 
        and added a pharmacy certification requirement, allowing Mifeprex and 
        its approved generic mifepristone, Mifepristone Tablets, 200mg, to be 
        dispensed by certified pharmacies, both in-person and by mail, as well 
        as by or under the supervision of certified prescribers;
Whereas the FDA relied on overwhelming evidence that medication abortion using 
        mifepristone is a safe and effective method to end a pregnancy;
Whereas leading medical and scientific organizations, including the World Health 
        Organization, the American Medical Association, the American College of 
        Obstetricians and Gynecologists, and the American Academy of Family 
        Physicians, recognize that mifepristone is safe and effective and 
        continue to recommend the availability of mifepristone for use in 
        obstetric care;
Whereas the importance of medication abortion is recognized globally, and the 
        World Health Organization has included mifepristone on its list of 
        essential medicines since 2005;
Whereas the safety record of mifepristone is demonstrated by its availability in 
        more than 90 countries, including countries without restrictions such as 
        the FDA risk evaluation and mitigation strategy requirement;
Whereas medication abortion accounted for more than half of all abortions in the 
        United States in 2021;
Whereas following the decision of the Supreme Court of the United States in 
        Dobbs v. Jackson Women's Health Organization, 142 S. Ct. 2228 (2022), to 
        overturn decades of precedent in Roe v. Wade, 410 U.S. 113 (1973), and 
        Planned Parenthood v. Casey, 505 U.S. 833 (1992), several States moved 
        to further restrict access to abortion care, compounding an already 
        complex landscape and exacerbating the existing abortion access crisis;
Whereas, as of December 13, 2023, 17 States have filed bills with antimedication 
        abortion provisions, and multiple States, including Florida, North 
        Carolina, and Wyoming, have enacted restrictions on medication abortion;
Whereas mere months after the decision of the Supreme Court of the United States 
        to overturn Roe v. Wade, 410 U.S. 113 (1973), and Planned Parenthood v. 
        Casey, 505 U.S. 833 (1992), in Dobbs v. Jackson Women's Health 
        Organization, 142 S. Ct. 2228 (2022), antiabortion groups have filed 
        baseless claims against the FDA over the approval of mifepristone, in an 
        attempt to remove mifepristone from the market;
Whereas the impact to the health and well-being of patients across the country 
        would be devastating if mifepristone were taken off the market;
Whereas abortion bans and restrictions force patients to travel greater 
        distances for care and face longer wait times, and force some patients 
        who are unable to access care to remain pregnant against their will;
Whereas, if mifepristone is taken off the market, providers may be prevented 
        from treating pregnancy loss using mifepristone, and abortion providers 
        and health care centers may be stretched impossibly thin and be unable 
        to keep up with the demand of patients who need abortion care; and
Whereas, due to discrimination, unnecessary restrictions on abortion, including 
        medication abortion, disproportionately push care out of reach for--

    (1) Black and Indigenous people;

    (2) people of color;

    (3) immigrants;

    (4) people with lower incomes;

    (5) people in rural communities;

    (6) LGBTQ+ people;

    (7) people living with disabilities; and

    (8) other pregnant people who have been disproportionately harmed by 
systemic inequities in health care: Now, therefore, be it

    Resolved, That it is the sense of the Senate that--
            (1) policies governing access to medication abortion care 
        in the United States should be grounded in science and based on 
        scientific review by the Food and Drug Administration of 
        available medical evidence;
            (2) Congress has granted the Food and Drug Administration 
        the authority to conduct pre-market approvals and post-market 
        reviews of prescription drug medications and medical devices 
        based on scientific determinations of their safety and 
        efficacy, and without interference from other branches of 
        government at the Federal, State, and local levels;
            (3) the Food and Drug Administration has performed 
        scientific reviews of mifepristone, and in the 2000 approval 
        and subsequent regulatory actions in 2011, 2016, 2019, and 
        2023, the Food and Drug Administration found mifepristone to be 
        safe and effective for women seeking abortions; and
            (4) medication abortion is an important method to ensure 
        equitable access to abortion for patients harmed by statutory, 
        regulatory, financial, and circumstantial restrictions that 
        have worsened reproductive health disparities for--
                    (A) Black and Indigenous people;
                    (B) people of color;
                    (C) immigrants;
                    (D) people with lower incomes;
                    (E) people in rural communities;
                    (F) LGBTQ+ people;
                    (G) people living with disabilities; and
                    (H) people in other marginalized communities.
                                 <all>
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