Anti-Abortion Activists Sue the FDA to Reverse Approval of the Abortion Pill

The anti-abortion group behind the Supreme Court’s overturning of Roe v. Wade has now filed a federal lawsuit seeking to reverse the approval of the abortion drug, mifepristone.

The Alliance Defending Freedom (ADF)—representing four Texas doctors and four anti-abortion groups—sued both the Food and Drug Administration and the Department of Health and Human Services, claiming that the FDA exceeded its authority when it approved mifepristone in 2000. (One of the four doctors named in the suit is George Delgado, a notorious anti-abortion activist who pioneered the lie that abortion pills can be “reversed.”) The suit asks for the drug’s approval to be undone.

One legal expert told The Wall Street Journal that the case would be difficult for the plaintiffs to win, but it’s still an earthquake of a suit given the popularity of abortions done with pills. Medication abortions, where a pregnant person takes mifepristone followed by misoprostol, accounted for 54 percent of all legal abortions in 2020. The drug is also used by people experiencing incomplete miscarriages.

ADF senior counsel Julie Marie Blake falsely claimed in a statement that mifepristone was dangerous: “Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they end a baby’s life and they pose serious and life-threatening complications to the mother.”

The group filed the suit in Amarillo, Texas, which is notable in itself. As University of Texas law professor Steve Vladeck has pointed out, suits filed there have a 95 percent chance of drawing an ultraconservative Trump-appointed judge, Matthew Kacsmaryk. This is the same judge who recently threw out anti-discrimination protections for LGBTQ people seeking healthcare and who, in 2021, said the Biden administration had to resume Trump’s “Remain in Mexico” policy. Texas Attorney General Ken Paxton has filed suits in Amarillo against the Biden administration at least 20 times.

Lawyers told the Wall Street Journal that the FDA has “appeared to move carefully on mifepristone” and that would work in its favor. “If they handle it well, FDA should prevail,” Daniel Kracov, an FDA lawyer at the firm Arnold & Porter, told the paper.

ADF is the same organization that masterminded the 15-week abortion ban in Mississippi that was at the heart of the Supreme Court case Dobbs v. Jackson Women’s Health Organization. The court’s decision in Dobbs overturned Roe. Justice Amy Coney Barrett also has connections to ADF, as the group paid her for speaking five times at its Blackstone Legal Fellowship, a summer program for law students meant to inspire a “distinctly Christian worldview in every area of law.”

The FDA said in a statement to the WSJ that mifepristone’s approval “was based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use—medical termination of early pregnancy.” An HHS spokesperson said: “Denying women access to any essential care they need is downright dangerous.”

Dr. Jen Villavicencio, lead for equity transformation at the American College of Obstetricians and Gynecologists, told Jezebel in a statement: “Medication abortion is backed by decades of data that clearly demonstrate its safety and efficacy. More importantly, mifepristone plays a critical role in the health and lives of people in need of abortion care and miscarriage management.”

We can probably expect more lawsuits about abortion pills. Advocates have pushed for the Biden administration to sue states that have banned abortion and argue that mifepristone should still be available because they can’t ban an FDA-approved drug. These kinds of lawsuits would rely on a legal argument that federal law pre-empts state law. But the Biden administration has so far not tried the tactic.