```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 309 Introduced in House (IH)]

<DOC>

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. 
 Connolly, 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 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
    Resolved, 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.
                                 <all>
```