Attorney General Becerra Files Amicus Brief Challenging FDA’s Unnecessary Barriers to Abortion Medication in Light of COVID-19 Pandemic

Thursday, June 4, 2020
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Current FDA restrictions impose unnecessary barriers to access and risk women’s health during global pandemic

SACRAMENTO – California Attorney General Xavier Becerra joined a multistate amicus brief supporting the American College of Obstetricians and Gynecologists' challenge to restrictions imposed by the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) 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. In the brief, the attorneys general argue that these restrictions interfere unjustifiably with the states’ efforts to minimize transmission of the COVID-19 virus while providing essential healthcare.

“As communities across the country — and HHS itself — work to promote telehealth to prevent the spread of coronavirus, women's healthcare must not be excluded,” 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. During this unprecedented pandemic and stay-at-home orders, the FDA unnecessarily and irresponsibly puts women’s lives at risk. This is 2020, not 1920.”

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 requires that:

  • 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 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, Maryland, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, 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.  

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