117 HRES 589 IH: Expressing the sense of the House of Representatives that policies governing access to medication abortion care in the United States should be equitable and based on science.
U.S. House of Representatives
2021-08-17
text/xml
EN
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IV
117th CONGRESS
1st Session
H. RES. 589
IN THE HOUSE OF REPRESENTATIVES
August 17, 2021
Mrs. Carolyn B. Maloney of New York (for herself, Ms. DeGette, Ms. Lee of California, Ms. Pressley, Mr. Nadler, Mr. Danny K. Davis of Illinois, Ms. Speier, Ms. Jacobs of California, Ms. Norton, Mr. Cicilline, Mr. Raskin, Ms. Schakowsky, Mr. Welch, Mr. Trone, Mr. Foster, Ms. McCollum, Mrs. Torres of California, Ms. Strickland, Ms. Chu, Mr. Connolly, Ms. Manning, Ms. Wasserman Schultz, Mr. Johnson of Georgia, Ms. Bonamici, Ms. Titus, Mr. Khanna, Mr. Vargas, Mr. Grijalva, Mr. Brown, Ms. Moore of Wisconsin, Ms. Lois Frankel of Florida, Mr. Pocan, Mr. Auchincloss, Mr. DeSaulnier, Mr. Torres of New York, Mr. Espaillat, Ms. Jayapal, Ms. Brownley, Ms. DelBene, Ms. Velázquez, Mr. Quigley, Mrs. Fletcher, Mr. Lieu, Ms. Dean, Mr. Cooper, Ms. Tlaib, Ms. Castor of Florida, Mr. Blumenauer, Mr. Jones, Mr. Smith of Washington, Ms. Wilson of Florida, Ms. Clarke of New York, Ms. Williams of Georgia, Miss Rice of New York, Ms. Garcia of Texas, Ms. DeLauro, Mr. Sarbanes, Mrs. Lawrence, Ms. Jackson Lee, Ms. Omar, Mr. Schiff, Mr. Evans, Mr. Kilmer, Mr. Tonko, Ms. Kelly of Illinois, Ms. Schrier, Mr. Veasey, Ms. Adams, Mrs. Watson Coleman, Mrs. Napolitano, Mr. Huffman, Mr. DeFazio, Mr. Bowman, Ms. Bass, Ms. Meng, and Ms. Bush) submitted the following resolution; which was referred to the Committee on Energy and Commerce
RESOLUTION
Expressing the sense of the House of Representatives that policies governing access to medication abortion care in the United States should be equitable and based on science.
Whereas Congress has authorized the Food and Drug Administration (FDA) under section 505–1(a)(1) of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 355–1(a)(1)) to impose Risk Evaluation and Mitigation Strategies (REMS) where “necessary to ensure that the benefits of [a] drug outweigh the risks of the drug”;
Whereas mifepristone received FDA approval more than two decades ago, and according to the FDA, mifepristone’s “efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare”;
Whereas the REMS restrictions for mifepristone require that it be dispensed to patients in person, that health care providers who prescribe mifepristone receive certification before doing so, and that certified prescribers obtain a signed safety agreement from patients before dispensing mifepristone to them;
Whereas of the more than 20,000 drugs the FDA regulates, mifepristone is the only drug that the FDA requires patients to obtain in person at a hospital, clinic, or medical office, but allows patients to self-administer unsupervised at home or at a location of their choosing;
Whereas the FDA permits numerous drugs posing greater safety risks than mifepristone to be administered to patients without REMS restrictions;
Whereas according to the American College of Obstetricians and Gynecologists, the REMS restrictions for mifepristone “have no medical basis, provide no patient benefit, and unnecessarily restrict access to care”;
Whereas the REMS restrictions for mifepristone are also opposed by the American Medical Association, the American Academy of Family Physicians, and other leading medical authorities;
Whereas the World Health Organization recognizes that medication abortion plays a crucial role in the provision of access to safe, effective abortion care;
Whereas lifting the in-person dispensing requirement and other REMS restrictions for mifepristone would improve access without weakening the strong safety profile of the drug;
Whereas patients should be able to receive medication abortion in the way that makes most sense for them from the provider of their choosing, whether that is at a health center, their local pharmacy, or delivered to their home;
Whereas unnecessary restrictions on abortion, including medication abortion, disproportionately push care out of reach for people of color, people with lower incomes, those in rural communities, and other pregnant people who have been disproportionately harmed by burdensome and medically unnecessary State and Federal restrictions on abortion care, as well as systemic inequities in health care that have been exacerbated by the coronavirus pandemic;
Whereas Congress required that any REMS not be “unduly burdensome on patient access to the drug, considering in particular . . . patients who have difficulty accessing health care (such as patients in rural or medically underserved areas)”, among other factors (section 505–1(f)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 355–1(f)(2)(C)(ii)));
Whereas, on April 12, 2021, the FDA announced that it would exercise enforcement discretion to temporarily lift the in-person dispensing requirement for mifepristone for the duration of the coronavirus public health emergency; and
Whereas, on May 7, 2021, the FDA indicated that it is conducting an evidence-based review of the REMS restrictions for mifepristone: Now, therefore, be it
That it is the sense of the House of Representatives that policies governing access to medication abortion care in the United States should—
(1)
be grounded in science and based on a scientific review of available medical evidence; and
(2)
ensure equitable access for patients harmed by restrictions that—
(A)
have impeded access to sexual and reproductive health care; and
(B)
have worsened health disparities for people of color, immigrants, people with lower incomes, and people in other marginalized communities.