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

IV 118TH CONGRESS 1ST SESSION H. RES. 309 Expressing the sense of the House of Representatives that the Food and Drug Administration has the authority to approve drugs for abortion care. IN THE HOUSE OF REPRESENTATIVES APRIL 19, 2023 Ms. MANNING (for herself, Ms. CARAVEO, Ms. MENG, Ms. NORTON, Mr. CON- NOLLY, Mr. HIGGINS of New York, Mr. PAPPAS, Ms. CHU, Mr. DELUZIO, Ms. PRESSLEY, Mr. TONKO, Ms. CROCKETT, Ms. TOKUDA, Ms. BUDZINSKI, Mr. IVEY, Mr. SCHNEIDER, Ms. SALINAS, Mr. PANETTA, Ms. PETTERSEN, Ms. SCHAKOWSKY, Mr. CASAR, Ms. PORTER, Mr. MRVAN, Mr. LARSEN of Washington, Ms. SCANLON, Mr. NICKEL, Ms. WILLIAMS of Georgia, Mrs. SYKES, Ms. ESCOBAR, Ms. WILD, Mr. AUCHINCLOSS, Mr. LANDSMAN, Ms. TITUS, and Ms. MOORE of Wisconsin) submitted the following resolution; which was referred to the Committee on Energy and Commerce RESOLUTION 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 Admin- istration (FDA) with the safety of the United States peo- ple 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, reg- ulate, and approve new drugs; VerDate Sep 11 2014 22:03 Apr 20, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6300 E:\BILLS\HR309.IH HR309 kjohnson on DSK79L0C42PROD with BILLS 2 •HRES 309 IH 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 over- sight of mifepristone by the Government Accountability Office found that the approval of mifepristone was con- sistent 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; VerDate Sep 11 2014 22:03 Apr 20, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6300 E:\BILLS\HR309.IH HR309 kjohnson on DSK79L0C42PROD with BILLS 3 •HRES 309 IH 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 injunc- tion that preliminarily enjoined the FDA to refrain from making changes to its approval of mifepristone in the plaintiffs’ States of Arizona, Colorado, Connecticut, Dela- ware, Hawaii, Illinois, Maine, Maryland, Michigan, Min- nesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington, and the Dis- trict of Columbia: Now, therefore, be it Resolved, That it is the sense of the House of Rep- 1 resentatives that— 2 (1) by enacting the Federal Food, Drug, and 3 Cosmetic Act and subsequent amendments, Congress 4 intended for and authorized the Food and Drug Ad- 5 ministration to review and approve drug applications 6 under its expert authority; 7 (2) Congress intended the provisions of the 8 Federal Food, Drug, and Cosmetic Act to govern 9 any review of Food and Drug Administration ap- 10 proval decisions to ensure that such decisions are 11 given due deference, are based on scientifically driv- 12 en assessments made by experts at Food and Drug 13 VerDate Sep 11 2014 22:03 Apr 20, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\HR309.IH HR309 kjohnson on DSK79L0C42PROD with BILLS 4 •HRES 309 IH Administration, and maximize the public’s access to 1 life- and health-preserving medications; 2 (3) Congress did not intend for Federal courts 3 to engage in independent judicial review of the sci- 4 entific evidence before the Food and Drug Adminis- 5 tration and make their own findings about a drug’s 6 safety and efficacy; 7 (4) a Federal court’s attempt to reverse 8 mifepristone’s approval represents a violation of the 9 intent of Congress in passing the Federal Food, 10 Drug, and Cosmetic Act; 11 (5) the stay of mifepristone’s approval by a dis- 12 trict court represents a threat to other duly Food 13 and Drug Administration-regulated products; and 14 (6) all people living in the United States should 15 have the ability to make decisions about their own 16 lives, futures, and reproductive health care, includ- 17 ing abortion. 18 Æ VerDate Sep 11 2014 22:03 Apr 20, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\HR309.IH HR309 kjohnson on DSK79L0C42PROD with BILLS