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Nov 18, 2022 - Health

Anti-abortion group sues FDA to challenge approval of abortion pills

Oriana González
Picture of three orange boxes of mifepristone

Photo: Robyn Beck/AFP via Getty Images

The Alliance of Hippocratic Medicine, an anti-abortion group, on Friday filed a lawsuit against the Food and Drug Administration to overturn the agency's approval of abortion pills.

Why it matters: It's the latest effort from an anti-abortion group to curtail access to abortion in the post-Dobbs era.

Don't forget: Major medical associations say that mifepristone is safe and effective, with the American Medical Association and the American College of Obstetricians and Gynecologists saying in a June letter to the FDA that the drug is a "safe, effective, and important component of treatment and management for early pregnancy loss."

Details: The group argues that in 2000, the FDA fast-tracked the approval of mifepristone for abortion, adding that the regulator "never studied the safety of the drugs" and "ignored the potential impacts" that the drug can have on minors.

  • "[T]he FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions."
  • "Since then, the FDA has not followed the science, reversed course, or fixed its mistakes — all to the detriment of women and girls. Instead, the FDA has doubled down on its actions and removed the few safeguards that were in place," the lawsuit says.
  • The plaintiffs in the case are asking a court in Texas to declare the drug's approval "unlawful" and to vacate it.

What they're saying: The FDA declined to provide comment about the lawsuit, telling Axios in a statement that the agency "does not comment on possible, pending or ongoing litigation."

Catch up fast: Last year, the FDA issued new guidance to allow for abortion pills to be made available via telemedicine permanently.

  • Previously, people were required to go to doctor's offices, hospitals or clinics to receive the abortion pill regimen. During the pandemic, the FDA temporarily changed that rule, allowing for people to access the pill by mail.
  • The FDA also added that certified pharmacies can also dispense the drug.

Read the lawsuit here:

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