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H.R. 5138 (114th): Over-The-Counter Contraceptives Act of 2016


The text of the bill below is as of Apr 29, 2016 (Introduced).


I

114th CONGRESS

2d Session

H. R. 5138

IN THE HOUSE OF REPRESENTATIVES

April 29, 2016

(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.

Short title

This Act may be cited as the Over-The-Counter Contraceptives Act of 2016.

2.

Applications for non-prescription contraceptive drugs

(a)

Priority review of application

The Secretary 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

Notwithstanding any other provision of law, with respect to individuals 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 Cosmetic Act (21 U.S.C. 353(b)(1)).

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of the Patient Protection and Affordable Care Act (Public Law 111–148), and the amendments made by such section, are repealed, and the Internal Revenue Code of 1986 shall be applied as if such section, and amendments, had never been enacted.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.