The U.S. Food and Drug Administration should immediately revisit restrictions on mifepristone, a drug used in medication abortion, so that patients do not need to travel during the coronavirus outbreak, three female Democratic senators said on Tuesday.
Under current regulations, patients seeking medication abortion ― a protocol that involves taking two drugs ― must pick up the medicines in person at an abortion clinic, even though the pills may be swallowed at home. That’s because mifepristone, the first of the two drugs used to terminate a pregnancy, is subject to a special set of FDA restrictions called Risk Evaluation and Mitigation Strategy. Under the REMS, patients cannot obtain mifepristone from a pharmacy or in the mail.
Sens. Elizabeth Warren (Mass.), Patty Murray (Wash.) and Tammy Baldwin (Wis.) implored the FDA to allow patients to receive the medications without having to go into a health care facility during the pandemic.
“People who need an abortion cannot delay care and should not needlessly risk coronavirus exposure,” the senators wrote in a letter to the regulator. “Given the years of scientific evidence indicating that medication abortion is a safe and effective treatment, we ask that FDA take immediate steps to temporarily exercise enforcement discretion on in-person dispensing requirements, so that people can more easily access abortion care without putting themselves or their health care providers at risk of infection from COVID-19.”
The senators join a growing chorus of calls for the FDA to allow medication to be prescribed over the phone or online and mailed to patients. A coalition of state attorneys general sent a similar letter to the agency at the end of March.
About 40% of all abortions in the U.S. are done using medication abortion. Women up to 10 weeks pregnant are eligible to terminate a pregnancy in this way.
The senators noted that research and clinical experience proves the safety of medication abortion. Leading medical groups such as the American College of Obstetricians and Gynecologists have advised the FDA to ease restrictions on the drug and make it available in retail pharmacies. Last year, Dr. Jane Henney, who was the FDA commissioner when mifepristone was approved in 2000, called on the agency to reevaluate regulations on the drug’s use.
The letter comes as a handful of states have moved to limit abortion care, claiming that medical supplies made scarce by the pandemic must be conserved for treatment of coronavirus patients.
In Texas, abortion has been halted for about three weeks, forcing patients to make potentially dangerous road trips to other states for care. On Tuesday, a federal appeals court ruled that medication abortions in the state could continue for now.
“Despite growing calls to take up measures that maintain medical care while limiting face-to-face medical interaction when possible, steps to protect access to reproductive health care have not been taken in the same way,” the senators wrote in their letter. “In fact, some states are actively restricting abortion care access, which both jeopardizes the health and well-being of patients seeking this time-sensitive health care and necessitates greater use of health care resources for prenatal, miscarriage, and childbirth care.”
The senators asked the FDA to respond within two weeks.
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