AMARILLO, Texas (KXAN) — A decision on whether to reverse a Food and Drug Administration approval of mifepristone, a pill used to end pregnancies, has been pushed back until at least Feb. 24. The decision, which some previously expected to come as soon as Friday, could affect access to the medication across the country.
Approved by the FDA in 2000, the drug is available by mail, telemedicine and pharmacy pickup. Mifepristone is one of two medications used to terminate pregnancies, and already over 29 states, including Texas, have laws or restrictions on the use of the medication, according to Guttmacher, a reproductive health research and policy organization.
Lawyers from the Alliance for Defending Freedom, a conservative Christian legal advocacy group, filed the lawsuit on Nov. 18 in an Amarillo federal court on behalf of four anti-abortion plaintiffs.
“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,” said Alliance for Defending Freedom Senior Counsel Julie Marie Blake in a November press release.
“The FDA never had the authority to approve these dangerous drugs for sale. We urge the court to listen to the doctors we represent who are seeking to protect girls and women from the documented dangers of chemical abortion drugs,” the press release continued.
Texas District Judge Matthew Kacsmaryk could side with the plaintiffs and grant an emergency injunction forcing the FDA to revoke its approval of mifepristone. Abortion advocates said this would pull the drug from the market and effectively initiate a nationwide ban on the medication.
“Medication abortion is the most commonly used method of abortion. Banning mifepristone nationwide would have severe consequences on people’s ability to access critical abortion and miscarriage care,” wrote the Nation Abortion Rights Action League on its website.
“Abortion access in our country is already in crisis after the Supreme Court overturned Roe v. Wade. If this judge takes medication abortion off the market, even more people will lose the freedom to make their own decisions about their lives, bodies and futures,” it continued.
CNBC reported Judge Kacsmaryk ordered Danco Laboratories, a manufacturer of mifepristone, to lay out its opposition to removing the medication for the U.S. market. The anti-abortion physicians will then have until Feb. 24 to respond.
David Donatti, a staff attorney for ACLU Texas, said mifepristone is now used in about half of all abortions executed in the U.S. and has had a stellar safety record in its decades of active use. He said mifepristone is considered to be as safe as Tylenol.
“These plaintiff groups have no injury whatsoever to themselves, they have no standing to sue or challenge the FDA regulations here,” he said. “This case should not see the light of day, and it’s very much my hope that Judge Kacsmaryk sees that.”
Donatti said this lawsuit poses institutional risks as well.
“Here you would have an unelected judge with no scientific or medical background making a decision that counters not only the weight of 20 years of American science, but the weight of science across the world,” Donatti said.
“These are difficult decisions that require weighing a lot of information. They require analyses by scientists and peer-reviewed journals. And this is just truly not the province of lawyers.”