Allowing Greater Access to Safe and Effective Contraception Act

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. It also removes certain limitations in relation to such products and health savings accounts, flexible spending arrangements, and other arrangements (e.g., limitations on the number of items that may be purchased).

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8428 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8428

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 19, 2022

Mrs. Hinson (for herself, Mrs. Miller-Meeks, Ms. Mace, Mrs. Rodgers of 
 Washington, and Mr. Smith of Missouri) 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 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; and
            (3) 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.

SEC. 3. EMPOWERING WOMEN TO MAKE THEIR OWN HEALTH DECISIONS.

    (a) Repeal of Limitations on Contributions to Flexible Spending 
Accounts.--Section 125 of the Internal Revenue Code of 1986 is amended 
by striking subsection (i).
    (b) Waiver of Stockpiling Rules.--The Secretary of the Treasury (or 
the Secretary's delegate) shall issue regulations or other guidance, or 
revise regulations and other guidance as necessary, to provide that for 
purposes of health savings accounts under section 223 of the Internal 
Revenue Code of 1986, Archer MSAs under section 220 of such Code, and 
health flexible spending arrangements and health reimbursement 
arrangements for purposes of sections 106 and 125 of such Code, rules 
prohibiting the purchase of multiples of any item or limiting the 
number of an item which can be purchased shall not apply to purchases 
of oral contraceptive drugs described in section 2(a)(1).
    (c) Effective Date.--The amendment made by subsection (a) shall 
apply to taxable years beginning after December 31, 2021.
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