番茄社区

WASHINGTON -- As the COVID-19 pandemic continues, the American College of Obstetricians and Gynecologists (ACOG) and other groups are raising concerns about states and the Trump administration using the pandemic to restrict access to abortion, while abortion opponents say the moves are meant to increase patient safety.

In March, ACOG and several other organizations and abortion clinics sued when states such as Texas included abortion among a list of elective procedures that were required to be stopped when those states shut down. Texas eventually in late April.

Then, late last month, ACOG and several other entities, including the Council of University Chairs of Obstetrics and Gynecology and the New York State Academy of Family Physicians, in federal court over its treatment of the abortion pill mifepristone (Mifeprex).

Like many drugs, mifepristone, which is also used in miscarriage care, is regulated under the FDA's risk evaluation and mitigation strategies (REMS) protocol. Under REMS, mifepristone 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, patients cannot pick up the drug from the pharmacy, or receive it in the mail.

During the pandemic, the FDA relaxed in-person REMS requirements for many other drugs, but not for mifepristone. "By making life-threatening viral exposure risks a condition of treatment for medication abortion and miscarriage care, the FDA's continued maintenance of the Mifepristone In-Person Dispensing Requirement jeopardizes the safety of patients, clinicians, and the public at large, with no countervailing benefit," the lawsuit said.

The complaint also noted that "of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing."

The FDA's singular treatment of mifepristone makes it clear "that there's a desire from somebody somewhere to restrict this medication from being used," said Jen Villavicencio, MD, an ob/gyn and family planning specialist in Michigan who provides medication abortions. Villavicencio said her state is "hostile to reproductive healthcare, and we have other requirements informed by REMS that are in addition to it ... Those laws are put in place in part because FDA REMS exist, and that signals to lawmakers it's a medication that requires this sort of monitoring" even though "we know from tons and tons of experience it is extraordinarily safe, and causes less deaths than Tylenol and ibuprofen."

Other than the requirement to provide the pill in person, the provisions of the mifepristone REMS -- including describing the drug's side effects, informing patients that it could potentially end a pregnancy, and requiring patients to sign a form acknowledging that they've been informed of the risks -- could be done on the phone or online, she said. "This requirement ... increases the risk of [COVID-19] exposure; that's really what this lawsuit is about."

ACOG that the in-person prescribing requirements "disproportionately affect patients from underserved communities who are burdened by the need to travel, arrange childcare, and present to their chosen clinician in person," which Villavicencio agreed with.

"These restrictions impact communities of color and people who have lower incomes much more greatly than anyone else. This is on top of the pandemic disproportionately killing black citizens." And unlike mifepristone, some of the drugs for which the REMS requirements are being relaxed normally require routine MRI surveillance or routine liver monitoring, she said.

Don't forget about the women who need the drug for miscarriage treatment, Villavicencio added. "About 20-25% of pregnancies will end in miscarriage, so there is a huge amount of patients facing this discrimination and hardship. Having to drive hundreds of miles from a place like rural Michigan to get to a physician who will hand her a pill -- it's a slap in the face to the practice of medicine."

Not everyone agrees with the lawsuit. "By suing to remove the FDA's REMS governing the prescription of Mifeprex, ACOG continues its sad record of putting abortion politics ahead of women's lives," the American Association of Pro-Life Obstetricians & Gynecologists (AAPLOG) said in a statement emailed to 番茄社区. "The FDA uses REMS to ensure that drugs with the potential for significant adverse effects do less harm. As medical professionals, AAPLOG members know that the FDA's REMS save lives and help lower the number of women severely harmed by Mifeprex. We encourage the FDA to mount a robust defense against this dangerous lawsuit."

The FDA declined to comment on the lawsuit and referred inquiries to the Department of Justice, which had not responded by presstime.

The lawsuit comes at a time when medication abortions performed via telemedicine appear to be on the rise, as 番茄社区 recently reported. Melissa Grant, chief operating officer of , a national abortion and birth control clinic, said that "there's definitely been a marked increase" in telemedicine abortions since stay-at-home orders were put in place.

Carafem, which directly mails abortion pills to patients as a part of a nationwide study, previously had one to two patients a week that were interested in receiving medication abortions from home. But since the pandemic, that number has increased to around eight to 10 patients a week, Grant said.

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