Expressing the sense of the House of Representatives that the Food and Drug Administration has the authority to approve drugs for abortion care.

Whereas Congress has entrusted the Food and Drug Administration (FDA) with the safety of the United States people for more than 80 years; Whereas, on June 25, 1938, President Franklin D. Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FFDCA) into law, authorizing the FDA to oversee, regulate, and approve new drugs; Whereas, on October 10, 1962, President John F. Kennedy signed the Kefauver-Harris Amendments to the FFDCA into law, charging the FDA with the authority to approve new drugs that were established by manufacturers to be proven safe and effective; Whereas, since the enactment of the FFDCA, the FDA has approved more than 19,000 prescription drug products for marketing; Whereas, on July 19, 1996, the FDA’s Reproductive Health Drugs Advisory Committee voted that mifepristone was safe for use and effective; Whereas, on September 28, 2000, the FDA approved the use of mifepristone for medical termination of pregnancy after a nearly 5-year review process; Whereas, in August 2008, an audit of the approval and oversight of mifepristone by the Government Accountability Office found that the approval of mifepristone was consistent with the approval and oversight of other drugs; Whereas mifepristone is used in more than half of abortion procedures nationwide; Whereas the safety and efficacy of medication abortion is supported by over two decades of scientific research and data collection; Whereas there is overwhelming evidence that medication abortion is safe and effective for virtually anyone who wants to end an early pregnancy, with a safety record of over 99 percent; Whereas more than 5,000,000 people in the United States have used mifepristone since its approval to safely end pregnancies at home and at health care centers, to safely treat miscarriages, and in other reproductive health care; Whereas access to mifepristone remains a lifeline for millions of Americans who seek reproductive health care; Whereas, on April 7, 2023, the United States District Court for the Northern District of Texas issued an injunction that stayed the FDA’s approval of mifepristone; and Whereas, on April 7, 2023, the United States District Court for the Eastern District of Washington issued an injunction that preliminarily enjoined the FDA to refrain from making changes to its approval of mifepristone in the plaintiffs’ States of Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington, and the District of Columbia: Now, therefore, be it That it is the sense of the House of Representatives that— (1) by enacting the Federal Food, Drug, and Cosmetic Act and subsequent amendments, Congress intended for and authorized the Food and Drug Administration to review and approve drug applications under its expert authority; (2) Congress intended the provisions of the Federal Food, Drug, and Cosmetic Act to govern any review of Food and Drug Administration approval decisions to ensure that such decisions are given due deference, are based on scientifically driven assessments made by experts at Food and Drug Administration, and maximize the public’s access to life- and health-preserving medications; (3) Congress did not intend for Federal courts to engage in independent judicial review of the scientific evidence before the Food and Drug Administration and make their own findings about a drug’s safety and efficacy; (4) a Federal court’s attempt to reverse mifepristone’s approval represents a violation of the intent of Congress in passing the Federal Food, Drug, and Cosmetic Act; (5) the stay of mifepristone’s approval by a district court represents a threat to other duly Food and Drug Administration-regulated products; and (6) all people living in the United States should have the ability to make decisions about their own lives, futures, and reproductive health care, including abortion.

Summary: This resolution expresses the sense of the House of Representatives that the Food and Drug Administration (FDA) has the authority to review and approve drugs pursuant to its own expertise, and that recent court decisions blocking the FDA's approval of mifepristone (which is used in medication abortion) violate congressional intent with respect to the FDA's authority.