What This Bill Does
This bill directs the Secretary of Health and Human Services to change the safety rules for mifepristone (a medication used for medical abortion). The bill requires that these safety rules allow patients to get the medication without visiting a doctor's office in person, through telehealth (video or phone visits), and by mail from pharmacies.
Who It Affects
The Secretary of Health and Human Services is directly responsible for making these changes. Patients who use mifepristone are affected. Pharmacies that are certified to dispense mifepristone are affected.
Key Provisions
• The safety rules for mifepristone cannot require patients to pick up the medication in person at a doctor's office (Sec. 2(a)(1))
• The safety rules must allow patients to get prescriptions for mifepristone through telehealth (Sec. 2(a)(2))
• All certified pharmacies must be allowed to dispense and mail mifepristone to patients (Sec. 2(a)(3))
• The Secretary can still change the safety rules in the future if there is sound scientific evidence, as long as any changes made after January 3, 2023 follow the three requirements above (Sec. 2(b))
What Changes
The current safety requirements for mifepristone would be replaced with new rules that remove the in-person visit requirement, allow telehealth prescriptions, and permit mail delivery from pharmacies.
Important Definitions
Mifepristone means the medication that is approved for medical abortion and is subject to a safety evaluation and mitigation strategy (Sec. 2(d))
Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 237
To preserve access to abortion medications.
IN THE SENATE OF THE UNITED STATES
FEBRUARY 2, 2023
Ms. SMITH (for herself, Mr. BOOKER, Mrs. GILLIBRAND, Mr. HICKENLOOPER,
Mr. KAINE, Mr. KING, Mr. MERKLEY, Mr. PADILLA, Mr. SCHATZ, and
Ms. STABENOW) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
A BILL
To preserve access to abortion medications.
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 ‘‘Protecting Access to
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Medication Abortion Act of 2023’’.
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SEC. 2. MODIFICATION OF REMS.
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(a) IN GENERAL.—The Secretary of Health and
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Human Services (referred to in this section as the ‘‘Sec-
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retary’’) shall ensure that the risk evaluation and mitiga-
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tion strategy under section 505–1 of the Federal Food,
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•S 237 IS
Drug, and Cosmetic Act (21 U.S.C. 355–1) that applies
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to mifepristone—
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(1) does not have an in-person dispensing re-
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quirement for such drug;
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(2) allows for patient access to prescriptions for
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such drug via telehealth; and
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(3) allows all pharmacies that are certified to
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dispense such drug to, at minimum, dispense and
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mail such drug to patients.
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(b) MODIFICATIONS.—Nothing in subsection (a) shall
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be construed to prevent the Secretary from approving a
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modification to the risk evaluation and mitigation strategy
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for mifepristone based on sound scientific evidence and in
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accordance with section 505–1(h) of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 355–1(h)), except
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that any modifications to such risk evaluation and mitiga-
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tion strategy made after January 3, 2023, shall be in ac-
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cordance with the requirements under paragraphs (1), (2),
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and (3) of subsection (a), unless the Secretary, based on
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sound scientific evidence and in accordance with section
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505–1 of such Act (21 U.S.C. 355–1), determines that
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a risk evaluation and mitigation strategy for mifepristone
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is no longer necessary.
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(c) CLARIFICATION.—Nothing in subsection (a) shall
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be construed to limit the authority of the Secretary to im-
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•S 237 IS
pose the requirements described in paragraphs (1), (2),
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and (3) of such subsection to a risk evaluation and mitiga-
2
tion strategy under section 505–1 of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 355–1) for any drug
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other than mifepristone.
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(d)
DEFINITION.—In
this
section,
the
term
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‘‘mifepristone’’ means mifepristone that is—
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(1) approved under subsection (c) or (j) of sec-
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tion 505 of the Federal Food, Drug, and Cosmetic
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Act (21 U.S.C. 355);
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(2) indicated for medical abortion; and
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(3) subject to a risk evaluation and mitigation
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strategy under section 505–1 of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 355–1).
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Æ
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