Memorandum on further efforts to safeguard access to reproductive health care services

MEMORANDUM TO THE ATTORNEY GENERAL
Secretary of Health and Human Services
Homeland Security Secretary

Subject: More efforts to protect access to reproduction
health care services

By the authority vested in me as President by the Constitution and laws of the United States, it is hereby ordered as follows:

Section 1. Policy. Since 2000, the drug mifepristone has been approved by the Food and Drug Administration (FDA) for use in the United States as a safe and effective method of terminating early pregnancy.

The Food and Drug Administration Amendment Act of 2007 (Public Law 110-85) requires the FDA to work with drug manufacturers to specify conditions for the use of certain drugs after considering six congressionally mandated factors. The Act sets out a detailed administrative process for developing such conditions for use, collectively known as the Risk Evaluation and Mitigation Strategy (REMS) for individual drugs. Mifepristone has long had REMS specifying conditions for its use.

On January 3, 2023, the FDA revised the REMS for mifepristone, following an independent and comprehensive review of the drug’s risks and benefits. FDA took evidence-based action that supports access to mifepristone by helping to ensure that healthcare providers and patients can use telehealth to prescribe and receive mifepristone by mail after the end of the COVID-19 public health emergency can continue. During the COVID-19 public health emergency, the FDA stopped enforcing a prior requirement that mifepristone be dispensed personally, and the FDA’s January 2023 REMS permanently removed the personally dispensed 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 that the benefits of the drug outweigh the risks. These changes also help ensure that patients can access mifepristone in the same way that they can access other prescribed drugs.

In the wake of the new REMS for mifepristone, there have been reports of attempts to stifle access to medication abortion. Some state officials have announced that they will impose restrictions to limit access to this evidence-based, safe and effective drug. For example, in a letter to the FDA, 22 state attorneys general threatened to enforce state laws that claimed to interfere with access to mifepristone. In Florida, the governor recently said that major pharmacy chains in the state would no longer offer mifepristone. Florida health officials issued guidance discouraging pharmacies from dispensing mifepristone, claiming that state law limits where abortion drugs can be provided to hospitals, clinics, or physician offices. These actions have created confusion, sowed fear, and may prevent patients from accessing a safe and effective FDA-approved drug.

In addition, those who provide reproductive health care face ever-increasing safety concerns. There are reports that some have vowed to make people uncomfortable entering pharmacies that dispense mifepristone.

In Executive Order 14076 (Protecting Access to Reproductive Health Care Services) of July 8, 2022, I directed the Secretary of Health and Human Services (HHS) to identify potential actions to expand the safety and access of abortion care, including medication abortion. instructed. To that end, I directed the Attorney General and the Secretary of Homeland Security to consider action that is appropriate and consistent with applicable law, that will protect the safety and security of patients, providers, and third parties, and that protects shall pharmacies and other entities that provide, dispense or distribute reproductive and related health care services.

Since the issuance of Executive Order 14076, my Administration has taken steps to clarify the protections available to those seeking reproductive health services. The Department of Justice announced the formation of a Reproductive Rights Task Force, which is focused, among other things, on evaluating and monitoring state and local law, regulation, and enforcement actions that provide or threaten to violate federal legal protections related to discovery. Let’s give reproductive care. HHS has published a report on reproductive health care, including abortion care; protect patients’ privacy and promote access to accurate information about reproductive health services; and ensure that patients receive proper medical treatment under the law. In addition, HHS continues to take action to help ensure nondiscrimination in healthcare delivery, including with respect to reproductive health care services and pharmacy access.

My Administration is committed to supporting safe access to mifepristone and protecting women’s fundamental freedoms, consistent with applicable law. Protecting and protecting reproductive rights is essential for the health, safety and progress of our nation. It is my Administration’s policy to protect against threats to the freedom and autonomy of the people who live in this country.

Sec. 2. Continuing to protect access to FDA-approved medicine. In light of recent developments and consistent with Executive Order 14076, within 60 days from 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 providers and institutions, including pharmacies, that provide reproductive health care and wish to legally prescribe and provide mifepristone; And

(ii) any further action, as appropriate and consistent with applicable law, to educate individuals on their ability to access legal reproductive care, free of threats or violence.

(b) The Attorney General, the Secretary of Homeland Security, and the Secretary of HHS, as appropriate, shall provide the Interagency Task Force on Reproductive Health Care Access established in Executive Order 14076 with information relating to:

(i) potential barriers faced by patients seeking legal access to mifepristone or other reproductive health care, as well as providers and institutions, including pharmacies, that provide reproductive health care in providing mifepristone or other reproductive health care, and any recommendations to overcome these barriers; And

(ii) whether any additional institutional resources may be necessary to overcome these constraints.

Sec. 3. General Provisions. (a) nothing in this memorandum shall be construed to affect or otherwise affect:

(i) an executive department or agency, or an authority conferred by law on its head; either

(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative or legislative proposals.

(b) This memorandum will be implemented in accordance with applicable law and subject to availability of appropriations.

(c) This memorandum is not intended to enforce any right or benefit, substantive or procedural, enforceable at law or in equity by either party against the United States, its departments, agencies, or entities, its officers, employees, is and does not. , or agent, or any other person.

(d) The Attorney General is authorized and directed to publish this memorandum federal register,

Joseph R. Biden Jr.

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