118 SRES 510 IS: 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.
U.S. Senate
2023-12-14
text/xml
EN
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III
118th CONGRESS
1st Session
S. RES. 510
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
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.