By SEAN MURPHY and MATTHEW PERRONE (Associated Press)
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 two-decade-old approval of an abortion drug, in a case that could threaten the most common form of abortion in the United States
Lawyers for the Alliance Defending Freedom group asked Judge Matthew Kacsmaryk during the hearing in Amarillo, Texas, to issue an immediate order revoking or suspending the approval of the drug mifepristone. Such a step would be an unprecedented challenge for the FDA, which approved combining mifepristone with a second pill as a safe and effective method of terminating a pregnancy in 2000.
During a 90-minute court appearance, alliance attorney Erik Baptist told the judge that removing mifepristone from the market “would restore proper policing power to states” — a reference to the US Supreme Court ruling last summer that overturned Roe v. Wade and left it to the 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 United States and has been increasingly prescribed since Roe was overthrown.
Recognizing the importance of the case, Kacsmaryk, who was appointed by then-President Donald Trump, asked Baptist if he could cite an earlier 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 “obstruction” of his group’s previous requests to remove the drug. The group petitioned the FDA in 2002 and 2019 seeking to restrict access to the pill.
FDA lawyers are expected to argue that withdrawing mifepristone would undermine reproductive care for American women and undermine the government’s scientific oversight of prescription drugs.
Kacsmaryk gave each side two hours to present their arguments – with time for rebuttal – in the high-stakes case. Mifepristone’s maker, Danco Laboratories, will join the FDA in advocating to keep the pill available.
A decision can come at any time after the conclusion of the arguments. A ruling against the drug would be quickly appealed by US Department of Justice lawyers representing the FDA, who would likely also request an emergency stay to prevent it from taking effect while the case proceeds.
One of the alliance’s main 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 up access to early HIV drugs. It has since been used to speed up drugs for cancer and other “serious or life-threatening illnesses”.
The alliance, which was also involved in the case that led to the Supreme Court overturning Roe, argues that pregnancy is not a disease and therefore mifepristone should not have been considered for accelerated approval.
“The contrast between these diseases and the FDA encroaching on pregnancy … the FDA regulations could not be more stark,” Baptist told Kacsmaryk.
But the FDA says the group’s argument is flawed in several respects. First, FDA regulations make it clear that pregnancy is considered a “medical condition” that can be serious and life-threatening in some cases.
Second, although the FDA reviewed the drug under its accelerated approval regime, it did not expedite the drug review. In fact, approval only came after four years of deliberation. Instead, the FDA used regulatory powers under the fast-track 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 Roe’s reversal. Removing mifepristone from the market would restrict access to abortion even in states where it is legal.
Members of the Women’s March advocacy group gathered outside the court, including one dressed as a kangaroo, to condemn the proceedings as a “kangaroo court”.
If Kacsmaryk rules against the FDA, it’s not clear how quickly access to mifepristone could be reduced or how the process would work. The FDA has its own procedures for revoking drug approvals that involve public hearings and scientific deliberation, which can take months or years.
If mifepristone is dropped, clinics and doctors who prescribe the combination say they would switch to using just misoprostol, the other drug used in the two-drug combination. This single-drug approach has a slightly lower rate of effectiveness in terminating a pregnancy, but it is widely used in countries where mifepristone is illegal or unavailable.
In addition to challenging the mifepristone approval process, the lawsuit targets several subsequent FDA decisions that loosened restrictions on the pill, including removing the requirement that women take it in person.
FDA lawyers 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. Withdrawing the drug more than 20 years after approval would be “extraordinary and unprecedented”, the government said in its legal response.
This story has been updated to correct that the plaintiff group’s name is Alliance Defending Freedom, not Alliance for Defending Freedom.
Perrone reported from Washington. Associated Press writer Jake Bleiberg in Dallas contributed to this report.
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