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 consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

To allow women greater access to safe and effective 

contraception. 

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 ‘‘Over-The-Counter 

5 Contraceptives Act of 2016’’. 


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1 SEC. 2. APPLICATIONS FOR NON-PRESCRIPTION CONTRA2 CEPTIVE 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)) for a contraceptive drug, provided that— 

9 (1) the supplemental application is with respect 

10 to a drug intended for routine use; and 

11 (2) if the supplemental application is approved, 

12 with respect to individuals aged 18 and older, such 

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

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

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

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

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

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

19 supplemental application that receives priority review 

20 under subsection (a). 

21 (c) OVER-THE-COUNTER AVAILABILITY.—Notwith22 standing any other provision of law, with respect to indi23 viduals under age 18, a contraceptive drug that is eligible 

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

25 to section 503(b)(1) of the Federal Food, Drug, and Cos26 metic Act (21 U.S.C. 353(b)(1)). 


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1 SEC. 3. EMPOWERING WOMEN TO MAKE THEIR OWN 

2 HEALTH DECISIONS. 

3 (a) NO LIMITATIONS BASED ON WHETHER A DRUG

4 IS PRESCRIBED.—Section 9003 of the Patient Protection 

5 and Affordable Care Act (Public Law 111–148), and the 

6 amendments made by such section, are repealed, and the 

7 Internal Revenue Code of 1986 shall be applied as if such 

8 section, and amendments, had never been enacted. 

9 (b) NO LIMITATIONS ON HEALTH FSAS.—Sections 

10 9005 and 10902 of the Patient Protection and Affordable 

11 Care Act (Public Law 111–148) and section 1403 of the 

12 Health Care and Education Reconciliation Act of 2010 

13 (Public Law 111–152), and the amendments made by 

14 such sections, are repealed, and the Internal Revenue 

15 Code of 1986 shall be applied as if such sections, and 

16 amendments, had never been enacted. 

Æ 


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