Further Efforts To Protect Access to Reproductive Healthcare Services, 4895-4897 [2023-01691]

Agencies

• Executive Office of the President

[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 [www.gpo.gov]
[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.
                
                
                    (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