Appeals court reverses Texas ruling nullifying FDA approval of abortion pill

Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022. — Enlarge / Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

A federal appeals court on Wednesday reversed part of a lower court’s controversial ruling that would have revoked regulatory approval for the abortion and miscarriage medication mifepristone, which the Food and Drug Administration granted in 2000. The appeals court also left in place the FDA’s 2019 authorization of a generic form of the drug, which is most commonly used.

However, the appeals court preserved other aspects of the earlier ruling, which, if upheld by the Supreme Court, would roll back FDA actions that expanded and eased access to mifepristone. Those include allowing mifepristone to be dispensed via mail and telemedicine, and used up to 10 weeks into a pregnancy rather than an earlier limit of seven weeks.

For now, today’s ruling by the conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans does not affect access to mifepristone. The Supreme Court said earlier this year that mifepristone would remain accessible under the current rules until the appeals process has concluded. The high court will ultimately decide the pill’s fate.

Mifepristone is an extremely safe medication that is commonly used in combination with another drug, misoprostol, for medication abortions and management of miscarriage.

If the Supreme Court upholds the restrictions on mifepristone access, it would mean that pregnant people would again need to go to a health care provider in person and schedule three in-person follow-up appointments for a medication abortion. Medication abortions using mifepristone would also be limited to seven weeks.

Leaders of the pharmaceutical and biotechnology industry decried the lower court’s initial ruling, issued by District Judge Matthew Kacsmaryk in Texas. The industry leaders said the ruling “fundamentally undermined” the FDA’s authority, “ignores decades of scientific evidence” on the safety and efficacy of mifepristone, and will weaken the country’s premier drug development pipeline.

https://arstechnica.com/?p=1961447