I 

118TH CONGRESS 

2D SESSION H. R. 8659 

To allow women greater access to safe and effective oral contraceptive drugs 

intended for routine use, and to direct the Comptroller General of the 

United States to conduct a study on Federal funding of contraceptive 

methods. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 7, 2024 

Mrs. HINSON (for herself, Mrs. MILLER-MEEKS, Ms. MALLIOTAKIS, and Mr. 

CISCOMANI) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on 

Ways and Means, Natural Resources, and Armed Services, for a period 

to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

To allow women greater access to safe and effective oral 

contraceptive drugs intended for routine use, and to direct the Comptroller General of the United States to 

conduct a study on Federal funding of contraceptive 

methods. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Allowing Greater Ac5 cess to Safe and Effective Contraception Act’’. 


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1 SEC. 2. SUPPLEMENTAL APPLICATIONS FOR OVER-THE2 COUNTER CONTRACEPTIVE DRUGS. 

3 (a) PRIORITY REVIEW OF APPLICATION.—The Sec4 retary of Health and Human Services (referred to in this 

5 section as the ‘‘Secretary’’) shall give priority review to 

6 any supplemental application submitted under section 

7 505(b) of the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 355(b)) if— 

9 (1) the supplemental application is with respect 

10 to an oral contraceptive drug intended for routine 

11 use; 

12 (2) the supplemental application is not with re13 spect to— 

14 (A) any emergency contraceptive drug; or 

15 (B) any drug that is also approved for in16 duced abortion; and 

17 (3) if the supplemental application is approved, 

18 with respect to individuals aged 18 and older, such 

19 drug would not be subject to section 503(b)(1) of 

20 the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 353(b)(1)). 

22 (b) FEE WAIVER.—The Secretary shall waive the fee 

23 under section 736(a)(1) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 379h(a)(1)) with respect to a 

25 supplemental application that receives priority review 

26 under subsection (a). 


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1 (c) OVER-THE-COUNTER AVAILABILITY.—Notwith2 standing any other provision of law, with respect to indi3 viduals under age 18, a contraceptive drug that is eligible 

4 for priority review under subsection (a) shall be subject 

5 to section 503(b)(1) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 353(b)(1)), including after approval 

7 of the supplemental application as described in subsection 

8 (a)(3). 

9 (d) APPLICABILITY.—This section applies with re10 spect to a supplemental application described in subsection 

11 (a) that— 

12 (1) is submitted before the date of enactment of 

13 this Act and remains pending as of such date of en14 actment; or 

15 (2) is submitted after such date of enactment. 

16 SEC. 3. GAO STUDY AND REPORT ON FEDERAL FUNDING OF 

17 CONTRACEPTIVE METHODS. 

18 Not later than one year after the date of enactment 

19 of this Act, the Comptroller General of the United States 

20 shall conduct a study and submit a report to Congress 

21 regarding the amount of Federal funds made available for 

22 the purposes of contraception reimbursement, inventory 

23 stocking, provider training, or patient education during 

24 the 15-year period immediately preceding such date of en25 actment, including such funding made available through— 


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1 (1) the Medicare program under title XVIII of 

2 the Social Security Act (42 U.S.C. 1395 et seq.); 

3 (2) the Medicaid program under title XIX of 

4 the Social Security Act (42 U.S.C. 1396 et seq.); 

5 (3) the Indian Health Service; 

6 (4) the American Health Benefit Exchanges es7 tablished under section 1311 or 1321 of the Patient 

8 Protection and Affordable Care Act (42 U.S.C. 

9 18031; 18041); 

10 (5) Federally-qualified health centers (as de11 fined in section 1905(l)(2)(B) of the Social Security 

12 Act (42 U.S.C. 1396d(l)(2)(B))); 

13 (6) title X of the Public Health Service Act (42 

14 U.S.C. 300 et seq.); 

15 (7) temporary assistance for needy families 

16 under part A of title IV of the Social Security Act 

17 (42 U.S.C. 601 et seq.); or 

18 (8) the TRICARE program (as defined in sec19 tion 1072 of title 10, United States Code). 

Æ 


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