SACRAMENTO, March 30, 2020 – California Attorney General Xavier Becerra today led a multistate coalition of 21 attorneys general in sending a letter to the U.S. Department of Health and Human Services and its U.S. Food and Drug Administration (FDA) requesting that they increase access to reproductive healthcare, including safe and legal abortion, during the COVID-19 pandemic. The coalition urges the Administration to waive or utilize its discretion on enforcement of its Risk Evaluation and Mitigation Strategy (REMS) designation, which impedes women’s access to the medication abortion prescription drug known as Mifepristone. The attorneys general call on the Administration to ensure that women across the country have access to this critical healthcare service while the pandemic leaves many women unable to seek in-person care, putting them in harm’s way. The American College of Obstetricians, the American Medical Association, and the American Association of Family Physicians all support removal of the REMS on medication abortion.
“As communities across the nation shelter in place to help prevent the spread of COVID-19, we must ensure that women can continue to safely access essential health services including safe and legal abortion,” said Attorney General Becerra. “Forcing women to unnecessarily seek in-person reproductive healthcare during this public health crisis is foolish and irresponsible. That’s why we’re calling on the Trump Administration to remove red tape that makes it more difficult for women to access the medication abortion prescription drug.”
In the letter, the attorneys general point out that medication abortion has been proven safe and effective, and should not be subject to unnecessary restrictions. 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. And according to the FDA, this medication “has been increasingly used as its efficacy and safety have become well-established by both research and experience.”
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. Under the REMS, the FDA requires that:
- Patients must be handed the medication at a clinic, medical office, or hospital under the supervision of a healthcare provider;
- Healthcare providers must be registered with the drug manufacturer; and
- Patients must sign a “Patient Agreement” form confirming that they received counseling on the risks associated with the medication.
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 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 is not only shortsighted but puts women across the country in harm’s way. Consequently, the attorneys general urge the Trump Administration to immediately remove the FDA REMS designation, and waive enforcement in the meantime, so that women can access constitutionally protected healthcare without putting themselves and their families at risk.
In filing the letter, Attorney General Becerra is joined by the attorneys general of Colorado, Connecticut, Delaware, Hawaii, Illinois, Iowa, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, and the District of Columbia.
A copy of the letter is available here.