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 to prioritize review of supplemental applications for over-the counter oral contraceptives that are intended for routine use.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4638 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4638

To allow women greater access to safe and effective oral contraceptive 
                    drugs intended for routine use.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 27, 2022

Ms. Ernst (for herself and Mr. Grassley) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To allow women greater access to safe and effective oral contraceptive 
                    drugs intended for routine use.

    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. SUPPLEMENTAL APPLICATIONS FOR OVER-THE-COUNTER 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)) if--
            (1) the supplemental application is with respect to an oral 
        contraceptive drug intended for routine use;
            (2) the supplemental application is not with respect to any 
        emergency contraceptive drug;
            (3) the supplemental application is not with respect to any 
        drug that is also approved for induced abortion; and
            (4) 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)), including after 
approval of the supplemental application as described in subsection 
(a)(3).
    (d) Applicability.--This section applies with respect to a 
supplemental application described in subsection (a) that--
            (1) is submitted before the date of enactment of this Act 
        and remains pending as of such date of enactment; or
            (2) is submitted after such date of enactment.
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