H. R. 5138
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
To allow women greater access to safe and effective contraception.
This Act may be cited as the
Over-The-Counter Contraceptives Act of 2016.
Applications for non-prescription contraceptive drugs
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—
the supplemental application is with respect to a drug intended for routine use; and
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)).
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).
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)).
Empowering women to make their own health decisions
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of the Patient Protection and Affordable Care Act (Public Law 111–148), and the amendments made by such section, are repealed, and the Internal Revenue Code of 1986 shall be applied as if such section, and amendments, had never been enacted.
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Care and Education Reconciliation Act of 2010 (Public Law 111–152), and the amendments made by such sections, are repealed, and the Internal Revenue Code of 1986 shall be applied as if such sections, and amendments, had never been enacted.