Section 1 Short title
This Act may be cited as the “Allowing Greater Access to Safe and Effective Contraception Act”.
Allowing Greater Access to Safe and Effective Contraception Act
A BILL
To allow women greater access to safe and effective oral contraceptive drugs intended for routine use.
Sec. 2 Supplemental applications for over-the-counter 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)) if—
the supplemental application is with respect to an oral contraceptive drug intended for routine use;
the supplemental application is not with respect to any emergency contraceptive drug; 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)).
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).
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).
Applicability— This section applies with respect to a supplemental application described in subsection (a) that—
is submitted before the date of enactment of this Act and remains pending as of such date of enactment; or
is submitted after such date of enactment.
Sec. 3 Empowering women to make their own health decisions
Repeal of limitations on contributions to flexible spending accounts— Section 125 of the Internal Revenue Code of 1986 is amended by striking subsection (i).
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).
Effective date— The amendment made by subsection (a) shall apply to taxable years beginning after December 31, 2021.