II 

Calendar No. 418 

118TH CONGRESS 

2D SESSION S. 4447 

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 SENATE OF THE UNITED STATES 

JUNE 4, 2024 

Ms. ERNST (for herself, Mr. GRASSLEY, Mrs. CAPITO, Mr. DAINES, Mr. 

YOUNG, Mr. TILLIS, Mr. CRUZ, Mr. MCCONNELL, Mr. RISCH, Mr. CORNYN, Mr. PAUL, Mr. THUNE, and Mr. MARSHALL) introduced the following bill; which was read the first time 

JUNE 5, 2024 

Read the second time and placed on the calendar 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Allowing Greater Ac3 cess to Safe and Effective Contraception Act’’. 

4 SEC. 2. SUPPLEMENTAL APPLICATIONS FOR OVER-THE5 COUNTER CONTRACEPTIVE DRUGS. 

6 (a) PRIORITY REVIEW OF APPLICATION.—The Sec7 retary of Health and Human Services (referred to in this 

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

9 any supplemental application submitted under section 

10 505(b) of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 355(b)) if— 

12 (1) the supplemental application is with respect 

13 to an oral contraceptive drug intended for routine 

14 use; 

15 (2) the supplemental application is not with re16 spect to— 

17 (A) any emergency contraceptive drug; or 

18 (B) any drug that is also approved for in19 duced abortion; and 

20 (3) if the supplemental application is approved, 

21 with respect to individuals aged 18 and older, such 

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

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

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

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

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


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

2 supplemental application that receives priority review 

3 under subsection (a). 

4 (c) OVER-THE-COUNTER AVAILABILITY.—Notwith5 standing any other provision of law, with respect to indi6 viduals under age 18, a contraceptive drug that is eligible 

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

8 to section 503(b)(1) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 353(b)(1)), including after approval 

10 of the supplemental application as described in subsection 

11 (a)(3). 

12 (d) APPLICABILITY.—This section applies with re13 spect to a supplemental application described in subsection 

14 (a) that— 

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

16 this Act and remains pending as of such date of en17 actment; or 

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

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

20 CONTRACEPTIVE METHODS. 

21 Not later than one year after the date of enactment 

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

23 shall conduct a study and submit a report to Congress 

24 regarding the amount of Federal funds made available for 

25 the purposes of contraception reimbursement, inventory 


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1 stocking, provider training, or patient education during 

2 the 15-year period immediately preceding such date of en3 actment, including such funding made available through— 

4 (1) the Medicare program under title XVIII of 

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

6 (2) the Medicaid program under title XIX of 

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

8 (3) the Indian Health Service; 

9 (4) the American Health Benefit Exchanges es10 tablished under section 1311 or 1321 of the Patient 

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

12 18031; 18041); 

13 (5) Federally-qualified health centers (as de14 fined in section 1905(l)(2)(B) of the Social Security 

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

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

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

18 (7) temporary assistance for needy families 

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

20 (42 U.S.C. 601 et seq.); or 

21 (8) the TRICARE program (as defined in sec22 tion 1072 of title 10, United States Code). 


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ssavage on LAPJG3WLY3PROD with BILLS
Calendar No. 418 

118TH CONGRESS 

2D SESSION S. 4447 

A BILL 

To allow women greater access to safe and effective 

funding of contraceptive methods. United States to conduct a study on Federal and to direct the Comptroller General of the oral contraceptive drugs intended for routine use, 

JUNE 5, 2024 

Read the second time and placed on the calendar 


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