Presidential Document2023-01691
Further Efforts To Protect Access to Reproductive Healthcare Services
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 26, 2023
Signed
January 22, 2023
Issuing agencies
Executive Office of the President
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 17 (Thursday, January 26, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Presidential Documents]
[Pages 4895-4897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01691]
Presidential Documents
Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 /
Presidential Documents
[[Page 4895]]
Memorandum of January 22, 2023
Further Efforts To Protect Access to Reproductive
Healthcare Services
Memorandum for the Attorney General[,] the Secretary of
Health and Human Services[, and] the Secretary of
Homeland Security
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Policy. Since 2000, the medication
mifepristone has been approved by the Food and Drug
Administration (FDA) for use in the United States as a
safe and effective method to end early pregnancy.
The Food and Drug Administration Amendments Act of 2007
(Public Law 110-85) requires the FDA, working with drug
manufacturers, to specify conditions for the use of
certain drugs after considering six congressionally
mandated factors. The Act sets forth a detailed
administrative process to develop such conditions for
use, known collectively as the Risk Evaluation and
Mitigation Strategies (REMS), for individual drugs.
Mifepristone has long had a REMS specifying the
conditions for its use.
On January 3, 2023, the FDA, after an independent and
comprehensive review of the risks and benefits of the
drug, modified the REMS for mifepristone. The FDA took
evidence-based action that supports access to
mifepristone by helping ensure that healthcare
providers and patients can continue to use telehealth
to prescribe and receive mifepristone by mail after the
end of the COVID-19 public health emergency. During the
COVID-19 public health emergency, the FDA stopped
enforcing a prior requirement that mifepristone be
dispensed in person, and the FDA's January 2023 REMS
permanently removed the in-person dispensing
requirement. Additionally, pharmacies can now choose to
become certified to dispense mifepristone to patients.
These changes seek to reduce the burden on the
healthcare delivery system while ensuring the benefits
of the medication outweigh the risks. These changes
also help ensure that patients can access mifepristone
similarly to how they would access other prescribed
medications.
In the wake of the new REMS for mifepristone, there
have been reports of efforts to suppress access to
medication abortion. Some State officials have
announced that they will impose restrictions to limit
access to this evidence-based, safe, and effective
medication. In a letter to the FDA, for example, 22
State Attorneys General threatened to enforce State
laws that purport to interfere with access to
mifepristone. In Florida, the Governor recently said
that major pharmacy chains in the State will not offer
mifepristone. Florida health officials issued guidance
discouraging pharmacies from dispensing mifepristone,
claiming that State law limits where abortion
medication can be provided to hospitals, clinics, or
physician offices. These actions have stoked confusion,
sowed fear, and may prevent patients from accessing
safe and effective FDA-approved medication.
At the same time, those who provide reproductive
healthcare continue to face heightened safety concerns.
There are reports that some have vowed to make people
uncomfortable entering pharmacies that dispense
mifepristone.
In Executive Order 14076 of July 8, 2022 (Protecting
Access to Reproductive Healthcare Services), I directed
the Secretary of Health and Human Services
[[Page 4896]]
(HHS) to identify potential actions to protect and
expand access to abortion care, including medication
abortion. In that order, I directed the Attorney
General and the Secretary of Homeland Security to
consider actions, as appropriate and consistent with
applicable law, that would protect the safety and
security of patients, providers, and third parties, and
that would protect the security of pharmacies and other
entities providing, dispensing, or delivering
reproductive and related healthcare services.
Since the issuance of Executive Order 14076, my
Administration has taken steps to clarify the
protections available to those who seek reproductive
health services. The Department of Justice announced
the formation of a Reproductive Rights Task Force,
which, among other things, is focused on evaluating and
monitoring State and local legislation, regulation, and
enforcement actions that threaten to infringe on
Federal legal protections relating to the provision or
pursuit of reproductive care. HHS has published a
report detailing its efforts to protect access to
reproductive healthcare, including abortion care;
protect patients' privacy and promote access to
accurate information about reproductive healthcare
services; and ensure that patients receive appropriate
medical treatment under the law. Furthermore, HHS has
continued taking action to help ensure non-
discrimination in healthcare service delivery,
including with respect to reproductive healthcare
services and pharmacy access.
My Administration remains committed to supporting safe
access to mifepristone, consistent with applicable law,
and defending women's fundamental freedoms. Defending
and protecting reproductive rights is essential to our
Nation's health, safety, and progress. It is the policy
of my Administration to protect against threats to the
liberty and autonomy of those who live in this country.
Sec. 2. Continuing to Protect Access to FDA-Approved
Medication. In light of recent developments and
consistent with Executive Order 14076, within 60 days
of the date of this memorandum:
(a) The Secretary of HHS, in consultation with the
Attorney General and the Secretary of Homeland
Security, shall consider:
(i) issuing guidance for patients seeking legal access to mifepristone, as
well as for providers and entities, including pharmacies, that provide
reproductive healthcare and seek to legally prescribe and provide
mifepristone; and
(ii) any further actions, as appropriate and consistent with applicable
law, to educate individuals on their ability to seek legal reproductive
care, free from threats or violence.
(b) The Attorney General, the Secretary of Homeland
Security, and the Secretary of HHS shall, as
appropriate, provide the Interagency Task Force on
Reproductive Healthcare Access, established in
Executive Order 14076, with information concerning:
(i) potential barriers faced by patients seeking legal access to
mifepristone or other reproductive healthcare, as well as by providers and
entities, including pharmacies, that provide reproductive healthcare in
providing mifepristone or other reproductive healthcare, and any
recommendations for addressing these barriers; and
(ii) whether any additional institutional resources may be necessary to
address these barriers.
Sec. 3. General Provisions. (a) Nothing in this
memorandum shall be construed to impair or otherwise
affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This memorandum shall be implemented consistent
with applicable law and subject to the availability of
appropriations.
[[Page 4897]]
(c) This memorandum is not intended to, and does
not, create any right or benefit, substantive or
procedural, enforceable at law or in equity by any
party against the United States, its departments,
agencies, or entities, its officers, employees, or
agents, or any other person.
(d) The Attorney General is authorized and directed
to publish this memorandum in the Federal Register.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
Washington, January 22, 2023
[FR Doc. 2023-01691
Filed 1-25-23; 8:45 am]
Billing code 4410-19-P
</pre></body>
</html>Indexed from Federal Register on January 26, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.