Longstanding FDA restrictions, currently halted by court order during COVID-19, impose unnecessary barriers to medication abortion
August 6, 2020 – SACRAMENTO – California Attorney General Xavier Becerra joined a multistate amicus brief supporting the American College of Obstetricians and Gynecologists, the Council of University Chairs of Obstetrics and Gynecology, the New York State Academy of Family Physicians, Sistersong Women of Color Reproductive Justice Collective, and Honor MacNaughton, M.D. These healthcare providers oppose the U.S. Food and Drug Administration’s (FDA) motion for stay of the district court ruling halting the federal government’s restrictions imposed on Mifepristone, the medication abortion prescription drug. Currently, due to FDA restrictions, Mifepristone can only be dispensed by certified providers at a hospital, clinic, or medical office — and not via pharmacy or mail — requiring women to go in person for a prescription. Evidence shows these restrictions are dated and not medically based. In the brief filed in the Fourth Circuit, the attorneys general argue that allowing enforcement of the FDA requirements during the current public health crisis will harm patient safety and the public interest by conditioning access to constitutionally protected abortion on an increased risk of virus infection and transmission. They also argue that allowing enforcement will undermine the amici’s ongoing efforts to manage the crisis through measures limiting unnecessary in-person contacts.
“It’s 2020, not 1920 – the FDA needs to join the 21st century and remove barriers to telehealth services, including care that women rely on for safe and legal abortion,” said Attorney General Becerra. “The FDA’s restrictive policy on Mifepristone targets women — and only women — forcing them to go in person to a doctor’s office to retrieve their prescription. These restrictions are dated and unnecessarily put women in harm’s way during this unprecedented COVID-19 pandemic. We’re proud to fight against these draconian restrictions and protect women’s healthcare, including the right to safe and legal abortion.”
In the brief, the coalition argues that the FDA’s Risk Evaluation and Mitigation Strategy (REMS) designation impedes women’s access to the medication abortion prescription drug despite the fact that it has been proven safe and effective. Mifepristone has been approved by the FDA since 2000, and it remains the only drug approved in the United States for pregnancy termination. Since its approval, about three million women in the United States have used the medication to terminate a pregnancy. Indeed, according to the FDA, this medication “has been increasingly used as its efficacy and safety have become well-established by both research and experience.” However, under REMS, the FDA imposed several unnecessary requirements:
- Healthcare providers must be registered with the drug manufacturer;
- Patients must sign a “Patient Agreement” form confirming that they received counseling on the risks associated with the medication; and
- Patients must be handed the medication at a clinic, medical office, or hospital under the supervision of a healthcare provider if the medication is prescribed for the purpose of terminating a pregnancy – yet the drug can be dispensed by mail in higher doses if prescribed for other purposes, such as ulcer relief.
During this unprecedented crisis, it is essential that women across the country have access to critical healthcare services. Many states have already taken steps to increase telehealth care at the federal government’s request. Yet, the current FDA REMS creates unnecessary barriers for women to access abortion care. In the brief, the coalition argues that these onerous and medically unnecessary requirements limit healthcare providers’ ability to assist their female patients, particularly during this global healthcare crisis. Furthermore, these requirements impose significant burdens on women in rural and medically underserved communities who would be required to travel long distances — sometimes up to 200 miles — for time-sensitive, in-person care. Forcing women to travel at a time when many states and the federal government are urging people to stay home to curb the spread of COVID-19 puts women across the country in harm’s way.
In June, Attorney General Becerra joined a coalition filing an amicus brief supporting ACOG’s challenge to the FDA’s REMS. In March, Attorney General Becerra led a multistate coalition in sending a letter to the FDA, asking them to remove REMS restrictions or waive enforcement of these requirements in light of the COVID-19 pandemic and nationwide stay-at-home orders.
In filing the amicus brief, Attorney General Becerra joins the attorneys general of New York, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, Washington, and the District of Columbia.
A copy of the brief is available here.
Source: CA. DOJ