[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4447 Placed on Calendar Senate (PCS)]
<DOC>
Calendar No. 418
118th CONGRESS
2d Session
S. 4447
To 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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 4, 2024
Ms. 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 time
June 5, 2024
Read the second time and placed on the calendar
_______________________________________________________________________
A BILL
To 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.
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--
(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.
SEC. 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).
Calendar No. 418
118th CONGRESS
2d Session
S. 4447
_______________________________________________________________________
A BILL
To 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.
_______________________________________________________________________
June 5, 2024
Read the second time and placed on the calendar