What This Bill Does
This bill directs the Secretary of Health and Human Services to give priority review to applications for birth control methods that women can use without a prescription or a health care professional's help. The bill also waives certain fees for these applications to make it easier and faster to get these contraceptives approved for sale.
Who It Affects
The Secretary of Health and Human Services, companies applying to sell self-administered birth control methods, and women seeking access to over-the-counter contraceptives.
Key Provisions
• The Secretary must give priority review to applications for birth control methods that do not require a prescription and do not need a health care professional to administer them (Sec. 2(a)).
• The Secretary must waive application fees for birth control applications that receive priority review under this section (Sec. 2(b)).
• This law applies to applications already pending when the law takes effect and to applications submitted after the law takes effect (Sec. 2(c)).
What Changes
Birth control applications that meet the criteria will receive faster review from federal regulators, and the companies submitting them will not have to pay certain application fees.
Important Definitions
A "self-administered contraceptive method" means a birth control drug, device or combination product that a woman can use by herself without help from a doctor or nurse. The bill specifically lists birth control pills, patches, vaginal rings and injections like depot medroxyprogesterone acetate as examples (Sec. 2(d)).
I
118TH CONGRESS
1ST SESSION H. R. 1512
To allow women greater access to a wider range of self-administered
contraceptives approved under the Federal Food, Drug, and Cosmetic Act.
IN THE HOUSE OF REPRESENTATIVES
MARCH 9, 2023
Ms. MACE introduced the following bill; which was referred to the Committee
on Energy and Commerce
A BILL
To allow women greater access to a wider range of self-
administered contraceptives approved under the Federal
Food, Drug, and Cosmetic Act.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Greater Access to Con-
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traceptive Options Act’’.
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SEC. 2. APPLICATIONS FOR NON-PRESCRIPTION CONTRA-
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CEPTIVE METHODS.
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(a) PRIORITY REVIEW OF APPLICATION.—The Sec-
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retary of Health and Human Services (referred to in this
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section as the ‘‘Secretary’’) shall give priority review to
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•HR 1512 IH
any supplemental application submitted under section
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505(b), 510(k), or 515 of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 355(b), 360, 360e) for a self-
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administered contraceptive method to be marketed without
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being subject to section 503(b)(1) of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) or treated
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as a prescription device.
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(b) FEE WAIVER.—The Secretary shall waive the fee
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under section 736(a)(1) or 738(a)(2) of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1);
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379j(a)(2)) (as applicable) with respect to a supplemental
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application that receives priority review under subsection
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(a).
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(c) APPLICABILITY.—This section applies with re-
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spect to a supplemental application described in subsection
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(a) that—
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(1) is submitted before the date of enactment of
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this Act and remains pending as of such date of en-
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actment; or
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(2) is submitted after such date of enactment.
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(d) SELF-ADMINISTERED CONTRACEPTIVE METHOD
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DEFINED.—In this Act, the term ‘‘self-administered con-
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traceptive method’’ means a drug or device (as those terms
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are defined in section 201 of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 321)) or combination product ap-
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•HR 1512 IH
proved for use under the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 321 et seq.) as a method of contra-
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ception that is administered without the intervention of
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a health care professional, including the birth control pill,
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patch, vaginal ring, or injection, such as depot
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medroxyprogesterone acetate.
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Æ
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