The FDA will allow mifepristone (Mifeprex) to be dispensed by mail during the pandemic, temporarily lifting previous requirements that it be given to patients in person, .
In a letter to the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), acting FDA Commissioner Janet Woodcock, MD, stated that the agency will "exercise enforcement discretion" regarding the in-person dispensing requirement for mifepristone, as long as the president's declaration of a public health emergency for COVID-19 remains in place.
Essentially, FDA won't enforce the in-person prescribing requirement that's part of the drug's risk management program.
Requiring patients to come to a hospital or clinic to pick up the abortion pill may increase their risk of contracting COVID-19, FDA said, so it will temporarily allow clinics to distribute the drug via telemedicine, directly by mail or through a mail-order pharmacy.
In a statement, for recognizing the "strong safety and efficacy profile of mifepristone for termination of early pregnancy and management of miscarriage."
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence – which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," the statement said.
Susan Bailey, MD, president of the American Medical Association, also praised the FDA's decision, that "the move ensures the health and safety of patients seeking access to the drug, especially those from marginalized communities that have been hardest hit by the pandemic."
Woodcock's letter cited four studies showing the safety and effectiveness of mifepristone. While she recognized some research limitations, she noted that "the overall findings from these studies do not appear to show increases in serious safety concerns (such as hemorrhage, ectopic pregnancy, or surgical interventions) occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic."
In combination with misoprostol, mifepristone can terminate early pregnancies up to 10 weeks' gestation. Mifepristone is regulated under the FDA's risk evaluation and mitigation strategies (REMS) protocol, which states it must be dispensed from provider to patient directly, in a clinic, hospital, or other medical setting. Although the actual abortion occurs at a patient's home, the REMS protocol prohibits patients from picking it up from the pharmacy or receiving it in the mail.
"What FDA has done here is said it will not enforce the in-person dispensing requirement that exists for mifepristone during the pandemic," said Skye Perryman, JD, chief legal officer at ACOG.
This decision not to enforce the in-person rule is part of a longstanding debate about whether or not the drug should be available remotely during the pandemic.
ACOG last May, seeking to end the in-person dispensing restrictions. In July, a federal court granted the group's request to temporarily suspend the rule, allowing clinicians to dispense the drug remotely. An appellate court quickly rejected the Trump administration's request to reverse the suspension.
Abortion care providers were permitted to dispense mifepristone remotely for nearly half a year. Then in January, the Supreme Court to reinstate the in-person dispensing requirement by a decision of 6 to 3 -- the first major abortion ruling since Justice Amy Coney Barrett was confirmed last fall. (That decision only applied to the lower court's injunction barring enforcement of the rule, however; no final decision has yet been rendered on the merits of ACOG's suit.)
Now, this decision by the FDA allows physicians to choose whether or not to mail abortion pills during the pandemic, without federal enforcement of the in-person dispensing rule.
"The FDA's decision will provide clinicians the flexibility to provide medication to their patients via telehealth," Perryman said. This flexibility, she added, will be only available to physicians who live in states where telemedicine is permitted for abortion care.
"In some states, there are limitations on telehealth or limitations on clinicians who provide reproductive healthcare," Perryman told 番茄社区. "We have long opposed those types of restrictions, because they do threaten access to care."
Ohio recently attempted to ban the use of telemedicine for abortion, which was . According to the Guttmacher Institute, require a clinician to be physically present when distributing drugs for a medication abortion, effectively prohibiting access to telemedicine for abortion care.
These in-person dispensing requirements, abortion rights advocates say, are medically unnecessary, as many studies show the safety and effectiveness of distributing the drugs via telemedicine, directly to patients at home. As telemedicine abortion has gained popularity during the pandemic, there is pressure on policymakers to turn to the medical literature.
Daniel Grossman, director of Advancing New Standards in Reproductive Health at the University of California San Francisco, said that he was "very heartened to see the FDA relying on medical evidence."
Grossman highlighted a that the agency included in its literature review, which showed no adverse consequences from receiving mifepristone via telemedicine.
"It shows quite clearly that the effectiveness of the medication abortion regimen is very high, similar to what has been shown in previous clinical trials, and adverse events or complications are very, very low," Grossman stated.
While the FDA's decision is a positive step, Grossman said, it is important to recognize that it's a short-term solution, since it will terminate whenever the president ends the public health emergency. However, given that the decision relied on medical literature that has previously established the safety and efficacy of remote distribution of mifepristone, he said he is hopeful that FDA will change the basic policy.
"I am quite optimistic that we will see a long-term change after the public health emergency ends," Grossman said. "Because from a public health perspective, it makes sense to help people access medication abortion as early as possible. Imposing medically unnecessary obstacles in a patient's path is bad for public health."