AMARILLO, Texas (AP) — A federal judge in Texas raised questions Wednesday about a Christian group's effort to overturn federal regulators' decades-old approval of a leading abortion drug, in a case that could threaten the country's most common method for ending pregnancies.
Judge Matthew Kacsmaryk heard more than four hours of debate over the Alliance Defending Freedom's request to revoke or suspend the Food and Drug Administration’s approval of mifepristone. Such a step would be an unprecedented challenge to the FDA and its authority in deciding which drugs to permit on the market.
Kacsmaryk said he would rule “as soon as possible,” without giving any clear indication of how he might decide and leaving open the question of whether access to the standard regimen for medication abortions might soon be curtailed throughout the country.
Mifepristone, when combined with a second pill, was approved in 2000 and is used to end pregnancies until their 10th week. It has been increasingly prescribed since last summer’s U.S. Supreme Court ruling overturning Roe v. Wade.
The Texas lawsuit has become the latest high-stakes legal battle over access to abortion since the question of its legality was returned to the states.
Kacsmaryk, who was appointed by former president Donald Trump, saved some of his most pointed questions for attorneys representing the alliance, which filed the case in Amarillo in anticipation of getting a favorable ruling.
“Explain to me why this court has that sweeping authority?” Kacsmaryk asked, in reference to the group's request to pull mifepristone from the market.
The judge also questioned whether the group had the legal standing to obtain a pretrial ruling, grilling both sides on U.S. Supreme Court cases that set out when such extraordinary relief is allowed.
Still, the judge also posed questions suggesting he was considering how he might draft a preliminary injunction in the plaintiffs' favor, at one point asking the alliance's lawyers if the issue of standing had been clearly addressed by appellate courts. At another point, he told them that their outline for the order of their arguments “tracks the elements for an injunction nicely.”
Lawyers representing the FDA argued that pulling mifepristone would disrupt reproductive care for women across the U.S.
“An injunction here would interfere with the interests of every state in the country” said Julie Harris of the U.S. Justice Department, which represented the FDA.
Harris and her colleagues also questioned whether the alliance — which filed its case on behalf of several anti-abortion doctors — had standing to bring the lawsuit, given that none of the plaintiffs could show the type of harm typically needed for such a legal action.
One of the chief arguments leveled against the FDA in the lawsuit is that the agency misused its authority when it originally approved the abortion pill.
The FDA reviewed the drug under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it has been used to expedite drugs for cancer and other “serious or life-threatening diseases."
“The plain text is clear it applies to illnesses,” argued Erik Baptist, the alliance's lead attorney. “Mifepristone is used to end pregnancies, and pregnancy isn’t an illness.”
The FDA rejected the group’s argument on multiple accounts. First, attorneys said FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, government attorneys said the terms of mifepristone’s use were replaced more than a decade ago by subsequent FDA programs passed by Congress, rendering the argument irrelevant.
Finally, while the FDA reviewed the drug under its accelerated approval regime, it didn’t expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone.
Legal experts have long been deeply skeptical of many of the arguments made by the alliance. And there is essentially no precedent for a lone judge overruling an FDA drug approval decision.
At one point, Kacsmaryk asked the alliance's attorneys about the possibility of suspending mifepristone's approval, without withdrawing it completely.
“Any relief you grant must be complete” and apply nationwide, Baptist said. “The harms of these abortion drugs know no bounds.”
Kacsmaryk gave each side two hours to make their arguments — with time for rebuttal — in the high-stakes case. Mifepristone’s manufacturer, Danco Laboratories, joined the FDA in arguing to keep the pill available.
A ruling could come any time. A decision against the drug would be swiftly appealed by the Justice Department, which would also likely seek an emergency stay to stop it from taking effect while the case proceeds.
Members of the Women’s March advocacy group rallied outside the courthouse, including one dressed as a kangaroo to decry the proceedings as a “kangaroo court.”
Ultimately, courthouse officials allowed 20 members of the media and 20 members of the general public to attend the hearing.
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 would 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 but is widely used in countries where mifepristone is illegal or unavailable.
In addition to challenging mifepristone's approval process, the lawsuit takes aim at several later FDA decisions that loosened restrictions on the pill, including eliminating a requirement that women pick it up in person.
___
AMARILLO, Texas (AP) — A conservative federal judge in Texas heard arguments Wednesday from a 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.
Lawyers for the group Alliance Defending Freedom asked Judge Matthew Kacsmaryk during the hearing in Amarillo, Texas, to issue 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 pregnancy in 2000.
During a 90-minute presentation to the court, 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.
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, who was appointed by then-President Donald Trump, asked Baptist 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 would upend reproductive care for U.S. women and undermine the government’s scientific oversight of prescription drugs.
Kacsmaryk gave 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. 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.
One of the alliance’s chief arguments against the FDA is that it misused its authorities when it originally approved the pill.
The FDA reviewed the drug under its so-called accelerated approval program, which was created in the early 1990s to speed access to the first HIV drugs. Since then, it’s been used to expedite drugs for cancer and other “serious or life-threatening diseases.”
The alliance, which was also involved in the lawsuit that led the Supreme Court to overturn Roe, argues that pregnancy is not a disease and therefore mifepristone should not have been considered for accelerated approval.
“The contrast between these illnesses and the FDA jamming pregnancy into ... the FDA regulations could not be more stark,” Baptist told Kacsmaryk.
But the FDA says the group’s argument is flawed on multiple counts. First, FDA regulations make clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, while the FDA reviewed the drug under its accelerated approval regime, it didn’t expedite the drug’s review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the accelerated program to add extra safety restrictions to mifepristone, including requiring physicians to be certified before prescribing it.
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.. Removing mifepristone from the market would curb access to abortion even in states where it’s legal.
Members of the Women’s March advocacy group rallied outside the courthouse, including one dressed as a kangaroo to decry the proceedings as a “kangaroo court.”
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 would 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 but is widely used in countries where mifepristone is illegal or unavailable.
In addition to challenging mifepristone's approval process, the lawsuit takes aim at 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.