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