Virtual clinics have a backup plan: misoprostol-only abortions

by The Insights

After legal disputes The rulings have sparked widespread uncertainty about the future of access to abortion pills in the United States, U.S.-based telehealth providers and mail-order pill sellers overseas want to make one thing clear: they are here to stay.

Since the U.S. Supreme Court struck down Roe vs. Wade, virtual abortion clinics have played a greater role in reproductive health care. Prior to this ruling, virtual abortion clinics accounted for 4% of abortions in the United States; after the decision, the number rose to 11%, according to a study by the Society of Family Planning.

The playing field changed for providers of abortion pills on April 8, when a ruling by Judge Matthew Kacsmaryk of the Northern District of Texas struck down the United States Food and Drug Administration’s approval of mifepristone, one of two drugs commonly used in a two-stage medical abortion. The decision ignored decades of scientific consensus on mifepristone’s safety and undermined the drug’s decades-old FDA approval. It was also in direct conflict with a ruling issued the same day by Judge Thomas Rice of the Eastern District of Washington, ordering US authorities to preserve access to the drugs.

The Fifth Circuit Court of Appeals on Wednesday partially reversed Kacsmaryk’s ruling, ordering that mifepristone remain legally available, but it also reversed the dispensation of mifepristone by mail in states where it was previously legal. The decision states that the drug must now be dispensed in person, reversing recent changes made by the FDA to ensure people’s access to health care.

This reversal is impacting a vast network of telehealth providers. During the pandemic, when the FDA eased restrictions on virtual abortion care, abortion pills became available by mail in 25 states and Washington, DC. Many of these pills were provided by services specifically devoted to reproductive telehealth, including virtual clinics like Hey Jane and Choice.

These businesses have prepared for increased restrictions and are now acting quickly to ensure they are still able to operate legally without a break. Currently, Hey Jane and Choice continue to offer mifepristone pills through the mail in the states they previously served.

However, it is unclear what might happen in the long term if the ban on mifepristone by mail is maintained. Even if the virtual clinics want to continue dispensing the pills, they may run into a problem with the two major US manufacturers, Danco Laboratories and GenBioPro. “They wouldn’t give the pills to mail-order pharmacies unless the Biden administration issues a discretionary enforcement notice, telling them they’re allowed to do so,” says law professor David Cohen. at Drexel University, citing an FDA policy. in which the agency does not take action against the release of unapproved drugs if there are extenuating circumstances.

The FDA declined to comment on whether it would exercise law enforcement discretion regarding the distribution of mifepristone by mail.

Contingency plans are in place if mifepristone becomes unavailable to US telehealth providers. Medical abortions usually consist of two pills: mifepristone and misoprostol. Mifepristone works by blocking the hormone progesterone, which is necessary for the continuation of pregnancies. While mifepristone is often colloquially referred to as “the abortion pill,” it is actually misoprostol that causes the uterine contractions that push fetal tissue out of the body. And since misoprostol is not subject to recent rulings, these companies may start offering misoprostol alone if manufacturers cut off access to mifepristone. This is not ideal, as the combination of pills produces the best results; misoprostol alone can cause additional cramping and nausea. But for providers determined to keep helping patients, it’s better than nothing.

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