118 S4447 PCS: Allowing Greater Access to Safe and Effective Contraception Act U.S. Senate 2024-06-05 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IICalendar No. 418118th CONGRESS2d SessionS. 4447IN THE SENATE OF THE UNITED STATESJune 4, 2024Ms. Ernst (for herself, Mr. Grassley, Mrs. Capito, Mr. Daines, Mr. Young, Mr. Tillis, Mr. Cruz, Mr. McConnell, Mr. Risch, Mr. Cornyn, Mr. Paul, Mr. Thune, and Mr. Marshall) introduced the following bill; which was read the first timeJune 5, 2024Read the second time and placed on the calendarA BILLTo allow women greater access to safe and effective oral contraceptive drugs intended for routine use, and to direct the Comptroller General of the United States to conduct a study on Federal funding of contraceptive methods.

1.

Short title

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

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—(A)any emergency contraceptive drug; or(B)any drug that is also approved for induced abortion; 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.

3.

GAO study and report on Federal funding of contraceptive methods

Not later than one year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study and submit a report to Congress regarding the amount of Federal funds made available for the purposes of contraception reimbursement, inventory stocking, provider training, or patient education during the 15-year period immediately preceding such date of enactment, including such funding made available through—(1)the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.);(2)the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.);(3)the Indian Health Service;(4)the American Health Benefit Exchanges established under section 1311 or 1321 of the Patient Protection and Affordable Care Act (42 U.S.C. 18031; 18041);(5)Federally-qualified health centers (as defined in section 1905(l)(2)(B) of the Social Security Act (42 U.S.C. 1396d(l)(2)(B))); (6)title X of the Public Health Service Act (42 U.S.C. 300 et seq.);(7)temporary assistance for needy families under part A of title IV of the Social Security Act (42 U.S.C. 601 et seq.); or(8)the TRICARE program (as defined in section 1072 of title 10, United States Code).

June 5, 2024Read the second time and placed on the calendar