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 Com-
mittee 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 consider-
ation 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 di-
rect the Comptroller General of the United States to 
conduct a study on Federal funding of contraceptive 
methods. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Allowing Greater Ac-
cess to Safe and Effective Contraception Act’’. 
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SEC. 2. SUPPLEMENTAL APPLICATIONS FOR OVER-THE- 
COUNTER CONTRACEPTIVE DRUGS. 
(a) PRIORITY REVIEW OF APPLICATION.—The Sec-
retary 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) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) if— 
(1) the supplemental application is with respect 
to an oral contraceptive drug intended for routine 
use; 
(2) the supplemental application is not with re-
spect to— 
(A) any emergency contraceptive drug; or 
(B) any drug that is also approved for in-
duced abortion; and 
(3) if the supplemental application is approved, 
with respect to individuals aged 18 and older, such 
drug would not be subject to section 503(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)(1)). 
(b) FEE WAIVER.—The Secretary shall waive the fee 
under section 736(a)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(a)(1)) with respect to a 
supplemental application that receives priority review 
under subsection (a). 
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(c) OVER-THE-COUNTER AVAILABILITY.—Notwith-
standing any other provision of law, with respect to indi-
viduals under age 18, a contraceptive drug that is eligible 
for priority review under subsection (a) shall be subject 
to section 503(b)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353(b)(1)), including after approval 
of the supplemental application as described in subsection 
(a)(3). 
(d) APPLICABILITY.—This section applies with re-
spect 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 en-
actment; or 
(2) is submitted after such date of enactment. 
SEC. 3. GAO STUDY AND REPORT ON FEDERAL FUNDING OF 
CONTRACEPTIVE METHODS. 
Not later than one year after the date of enactment 
of this Act, the Comptroller General of the United States 
shall conduct a study and submit a report to Congress 
regarding the amount of Federal funds made available for 
the purposes of contraception reimbursement, inventory 
stocking, provider training, or patient education during 
the 15-year period immediately preceding such date of en-
actment, including such funding made available through— 
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(1) the Medicare program under title XVIII of 
the Social Security Act (42 U.S.C. 1395 et seq.); 
(2) the Medicaid program under title XIX of 
the Social Security Act (42 U.S.C. 1396 et seq.); 
(3) the Indian Health Service; 
(4) the American Health Benefit Exchanges es-
tablished under section 1311 or 1321 of the Patient 
Protection and Affordable Care Act (42 U.S.C. 
18031; 18041); 
(5) Federally-qualified health centers (as de-
fined in section 1905(l)(2)(B) of the Social Security 
Act (42 U.S.C. 1396d(l)(2)(B))); 
(6) title X of the Public Health Service Act (42 
U.S.C. 300 et seq.); 
(7) temporary assistance for needy families 
under part A of title IV of the Social Security Act 
(42 U.S.C. 601 et seq.); or 
(8) the TRICARE program (as defined in sec-
tion 1072 of title 10, United States Code). 
Æ 
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