[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