I 
114TH CONGRESS 
2D SESSION 
H. R. 5138 
To allow women greater access to safe and effective contraception. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 29, 2016 
Mrs. LOVE (for herself, Mrs. COMSTOCK, Mrs. LUMMIS, Ms. MCSALLY, Mr. 
COFFMAN, Mr. STEWART, and Mr. KINZINGER of Illinois) introduced the 
following bill; which was referred to the Committee on Ways and Means, 
and in addition to the Committee on Energy and Commerce, 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 
contraception. 
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 ‘‘Over-The-Counter 
Contraceptives Act of 2016’’. 
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SEC. 2. APPLICATIONS FOR NON-PRESCRIPTION CONTRA-
CEPTIVE 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)) for a contraceptive drug, provided that— 
(1) the supplemental application is with respect 
to a drug intended for routine use; and 
(2) 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). 
(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)). 
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SEC. 3. EMPOWERING WOMEN TO MAKE THEIR OWN 
HEALTH DECISIONS. 
(a) NO LIMITATIONS BASED ON WHETHER A DRUG 
IS PRESCRIBED.—Section 9003 of the Patient Protection 
and Affordable Care Act (Public Law 111–148), and the 
amendments made by such section, are repealed, and the 
Internal Revenue Code of 1986 shall be applied as if such 
section, and amendments, had never been enacted. 
(b) NO LIMITATIONS ON HEALTH FSAS.—Sections 
9005 and 10902 of the Patient Protection and Affordable 
Care Act (Public Law 111–148) and section 1403 of the 
Health Care and Education Reconciliation Act of 2010 
(Public Law 111–152), and the amendments made by 
such sections, are repealed, and the Internal Revenue 
Code of 1986 shall be applied as if such sections, and 
amendments, had never been enacted. 
Æ 
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