Conservative Texas judge weighs challenge to abortion pills

By SEAN MURPHY and MATTHEW PERRONE
Associated Press

AMARILLO, Texas (AP) — A federal judge appointed by former President Donald Trump heard arguments Wednesday from a conservative Christian group seeking to overturn the Food and Drug Administration’s more than 2-decade-old approval of an abortion medication, in a case that could threaten the most common form of abortion in the U.S.

The Alliance for Defending Freedom asked Judge Matthew Kacsmaryk during the hearing in Amarillo, Texas, for an immediate order that would revoke or suspend the drug mifepristone’s approval. Such a step would be an unprecedented challenge to the FDA, which approved mifepristone in combination with a second pill as a safe and effective method for ending abortion in 2000.

Alliance attorney Erik Baptist told the judge that removing mifepristone from the market “would restore proper policing power to the states” — a reference to last summer’s U.S. Supreme Court ruling that overturned Roe v. Wade and left it to states to decide on the legality of abortion. Baptist and a second attorney presented their arguments for 90 minutes.

Mifepristone, when combined with a second pill, has become the most common method of abortion in the U.S. and has been increasingly prescribed since Roe was overturned.

Acknowledging the significance of the case, Kacsmaryk asked Baptist at one point if he could cite a prior example of a court removing an FDA-approved drug after many years on the market.

Baptist acknowledged that there are no prior examples, but he blamed the drug’s longevity on the FDA’s “stonewalling” of his group’s prior requests to remove the drug. The group petitioned the FDA in 2002 and in 2019 seeking to curb access to the pill.

Lawyers for the FDA are expected to argue that pulling mifepristone from the market would upend reproductive care for U.S. women and undermine the government’s scientific oversight of prescription drugs.

Kacsmaryk has given each side two hours to make their arguments — with time for rebuttal — in the high-stakes case. Mifepristone’s manufacturer, Danco Laboratories, will join the FDA in arguing to keep the pill available.

A ruling could come any time after arguments conclude.

The hearing is the first in the case and is being closely watched by groups on both sides of the abortion issue in light of the reversal of Roe.

The Alliance for Defending Freedom was also involved in the lawsuit that led the Supreme Court to overturn Roe and return decisions on abortion to the states. Removing mifepristone from the market would curtail access to abortion even in states where it’s legal.

If Kacsmaryk rules against the FDA, it’s unclear how quickly access to mifepristone could be curtailed or how the process would work. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberations, which can take months or years.

If mifepristone is sidelined, clinics and doctors that prescribe the combination say they plan to switch to using only misoprostol, the other drug used in the two-drug combination. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, though it is widely used in countries where mifepristone is illegal or unavailable.

The Texas lawsuit alleges that the FDA’s approval of mifepristone in 2000 was flawed for several reasons, including an inadequate review of the pill’s safety risks. The suit also challenges several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.

Lawyers for the FDA have pointed out that serious side effects with mifepristone are rare, and the agency has repeatedly affirmed the drug’s safety by reviewing subsequent studies and data. Pulling the drug more than 20 years after approval would be “extraordinary and unprecedented,” the government stated in its legal response.

A decision against the drug would be swiftly appealed by U.S. Department of Justice attorneys representing the FDA, who would also likely seek an emergency stay to stop it from taking effect while the case proceeds.

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Perrone reported from Washington. Associated Press writer Jake Bleiberg in Dallas contributed to this report.

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