Title: Allowing Greater Access to Safe and Effective Contraception Act
Policy area: Health

Summary:
Allowing Greater Access to Safe and Effective Contraception Act
This bill requires the Food and Drug Administration (FDA) to prioritize review of supplemental drug applications (applications to modify the approved use of a drug) for contraceptive drugs intended for routine use that would be available to individuals aged 18 and older without a prescription. The FDA must waive user fees for such supplemental drug applications. Any drug that is eligible for this priority review must be a prescription drug for individuals under age 18.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 93 Introduced in Senate (IS)]

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115th CONGRESS
  1st Session
                                 S. 93

   To allow women greater access to safe and effective contraception.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 10, 2017

 Mrs. Ernst (for herself, Mr. Gardner, and Mr. Heller) introduced the 
 following bill; which was read twice and referred to the Committee on 
                                Finance

_______________________________________________________________________

                                 A BILL


 
   To allow women greater access to safe and effective contraception.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Allowing Greater Access to Safe and 
Effective Contraception Act''.

SEC. 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)).

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.
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