OTC Act of 2023

Orally Taken Contraception Act of 2023 or the OTC Act of 2023

This bill requires the Food and Drug Administration (FDA) to issue guidance on the approval process for over-the-counter oral contraceptives so as to encourage drug manufacturers to submit applications for approval. The FDA must also evaluate (1) whether and to what extent consumers understand the labeling on oral contraceptives, and (2) whether the labeling could be improved.

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4626 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4626

      To encourage sponsors of oral contraceptive drugs to submit 
 applications for the approval of such drugs as over-the-counter, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 13, 2023

Mrs. Miller-Meeks (for herself, Mrs. Kiggans of Virginia, Ms. Greene of 
Georgia, Mrs. Bice, Ms. Salazar, Mrs. Chavez-DeRemer, Ms. Malliotakis, 
Mrs. Kim of California, Mrs. Harshbarger, and Ms. Mace) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
      To encourage sponsors of oral contraceptive drugs to submit 
 applications for the approval of such drugs as over-the-counter, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Orally Taken Contraception Act of 
2023'' or the ``OTC Act of 2023''.

SEC. 2. FDA GUIDANCE ON CHANGING MARKETING STATUS OF CONTRACEPTIVE 
              DRUGS TO OVER-THE-COUNTER.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services 
acting through the Commissioner of Food and Drugs, for purposes of 
encouraging sponsors of oral contraceptive drugs to submit applications 
for the approval of oral contraceptive drugs to be marketed without 
being subject to section 503(b)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(b)(1)), shall issue guidance that--
            (1) provides a detailed description of the review process 
        for the--
                    (A) approval of drugs under section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
                    (B) marketing authorization of over-the-counter 
                drugs under section 505G of such Act (21 U.S.C. 355h); 
                and
                    (C) licensure of biological products under section 
                351 of the Public Health Service Act (42 U.S.C. 262);
            (2) provides for background information on oral 
        contraceptive drugs, including--
                    (A) the history of approval, marketing 
                authorization, or licensure of oral contraceptive drugs 
                under the provisions of law specified in paragraph (1);
                    (B) the standards used to grant such approval, 
                marketing authorization, or licensure; and
            (3) specifies the benefit-risk considerations that the 
        Secretary uses to determine whether to approve, authorize for 
        marketing, or license oral contraceptive drugs; and
            (4) details the Secretary's efforts to facilitate the 
        development of oral contraceptive drugs to be marketed without 
        being subject to section 503(b)(1) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 353(b)(1)).
    (b) Labeling Comprehension Study.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs, 
        shall complete a study on consumer comprehension of the 
        labeling of oral contraceptive drugs.
            (2) Issues to be studied.--The study required by paragraph 
        (1) shall address how the labeling of oral contraceptive drugs 
        could be improved to increase consumer comprehension of the 
        information conveyed in such labeling, including the proper use 
        of such drugs and for whom such drugs are indicated.
            (3) Completion; publication.--The Secretary of Health and 
        Human Services, acting through the Commissioner of Food and 
        Drugs, shall--
                    (A) not later than 1 year after the date of the 
                enactment of this Act, complete the study required by 
                paragraph (1); and
                    (B) publish the results of such study in 
                conjunction with the issuance of the guidance required 
                by subsection (a).
    (c) Oral Contraceptive Drug Defined.--In this section, the term 
``oral contraceptive drug'' means a drug (as defined in section 
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(g)(1)) that--
            (1) is used to prevent fertilization;
            (2) is administered orally;
            (3) is solely intended for routine use and not as an 
        emergency contraceptive;
            (4) does not include any drug, substance, or combination of 
        drugs or substances used after fertilization; and
            (5) does not include any drug or other method used to 
        terminate a pregnancy.
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