Greater Access to Contraceptive Options Act

Bill: 118-hr-1512
Sponsor: full_name: Rep. Mace, Nancy [R-SC-1]
Introduced: 2023-03-09
Policy area: Health
Latest action: action_date: 2023-03-17
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-03-09
action_desc: Introduced in House
text: <p><b>Greater Access to Contraceptive Options Act</b></p> <p>This bill requires the Food and Drug Administration to prioritize review of supplemental applications for over-the counter, self-administered contraceptives (i.e., contraception that is administered without the intervention of a health care professional).</p>

tv_txt: I 118th CONGRESS 1st Session H. R. 1512 IN THE HOUSE OF REPRESENTATIVES March 9, 2023 Ms. Mace introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To allow women greater access to a wider range of self-administered contraceptives approved under the Federal Food, Drug, and Cosmetic Act.

1. Short title This Act may be cited as the Greater Access to Contraceptive Options Act . 2. Applications for non-prescription contraceptive methods (a) Priority review of application The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall give priority review to any supplemental application submitted under section 505(b), 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) , 360, 360e) for a self-administered contraceptive method 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) ) or treated as a prescription device. (b) Fee waiver The Secretary shall waive the fee under section 736(a)(1) or 738(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h(a)(1) ; 379j(a)(2)) (as applicable) with respect to a supplemental application that receives priority review under subsection (a). (c) Applicability This section applies with respect to a supplemental application described in subsection (a) that— (1) is submitted before the date of enactment of this Act and remains pending as of such date of enactment; or (2) is submitted after such date of enactment. (d) Self-Administered contraceptive method defined In this Act, the term self-administered contraceptive method means a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) or combination product approved for use under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 et seq. ) as a method of contraception that is administered without the intervention of a health care professional, including the birth control pill, patch, vaginal ring, or injection, such as depot medroxyprogesterone acetate.