The FDA is urging the federal judge — an appointee of former President Donald Trump — not to issue a preliminary ruling in the case that centers on whether the agency exceeded its authority to approve mifepristone in 2000, whether it erred in making changes to when and how the medication can be used in 2016 and if sending the medication through the mail is legal.
The federal government, in a court filing on Jan. 13, said the anti-abortion groups’ lawsuit to force the FDA to pull the pharmaceutical from the market “is extraordinary and unprecedented.”
“Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay,” wrote attorneys for the U.S. Justice Department.
The 52-page opposition to a preliminary ruling says such a decision “would cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”
Suit filed in mid-November
The Alliance for Hippocratic Medicine along with the American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatricians and Christian Medical & Dental Associations filed the lawsuit in mid-November along with four doctors from California, Indiana, Michigan and Texas.
They argue in the 113-page lawsuit the FDA “exceeded its regulatory authority” to approve mifepristone and misoprostol to end a pregnancy within the United States. The two-drug regimen is currently approved up to 10 weeks into a pregnancy, though it was originally approved for up to seven weeks gestation.
“This case challenges the FDA’s failure to abide by its legal obligations to protect the health, safety, and welfare of women and girls when the agency authorized the chemical abortion drugs mifepristone and misoprostol for use in the United States and subsequently eliminated necessary safeguards for pregnant women and girls who undergo this dangerous drug regimen,” wrote attorneys from the Alliance Defending Freedom, the anti-abortion legal organization leading the case.
The lawsuit then calls on the court to “issue a preliminary and permanent injunction ordering Defendants to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs.”
If the judge declines to do that, he could rule in support of one, or several, of the anti-abortion groups’ other claims in the case.
That could mean a court order to eliminate the mail-order option, reinstate the in-person dispensing requirement, re-apply in-person dispensing solely to doctors instead of prescribing healthcare providers like physician’s assistants or nurse practitioners, or wipe out the 2016 FDA changes to when and how the medication could be used.
Among those were increasing the number of weeks into a pregnancy mifepristone can be used from seven to 10 and making changes to the dosage.
The lawsuit doesn’t address the FDA’s decision in early January to allow commercial pharmacies to dispense the abortion medication after receiving a prescription from a healthcare provider; though if the judge were to require in-person dispensing by a doctor again, pharmacy pick-up of a prescription wouldn’t be possible.
Abortion rights advocates said during a briefing in January that while the case would be a joke in any other court, they are taking the filing in the North District of Texas seriously, in part because of the judge who will handle the case.
Kirsten Moore, director of the Expanding Medication Abortion Access Project, said “the idea that a drug approval infrastructure could be up to a single judge or that states would be able to recreate their own drug approval process is rash and downright dangerous.”
Jennifer Dalven, director of the Reproductive Freedom Project at the American Civil Liberties Union, said the case “would be laughed out of court if it were filed somewhere else” due to several procedural defects.
But because of the federal district court and the judge, Dalven said, she is taking the case “quite seriously.”
“Mifepristone was approved over 20 years ago. It’s been used safely and effectively by millions of people for early abortion care and to treat miscarriages,” Dalven said. “But unfortunately, in the world we are living in today, we have to take this case seriously.”
A decision from the judge could happen any time after Feb. 10, when the last filings are due in the case, Dalven said.
Abortion rights advocates, she said, weren’t yet sure if the judge would hear oral arguments or issue a ruling without taking that step.
Trump appointees
The lawsuit is working its way through the U.S. District Court for the North District of Texas, the same district that issued a preliminary ruling in favor of the Texas attorney general and anti-abortion organizations regarding emergency medical treatment for pregnant patients.
That Emergency Medical Treatment and Labor Act case, State of Texas v. Becerra, was filed in the Lubbock Division and overseen by Judge James Wesley Hendrix, while the medication abortion case was filed in the Amarillo Division and is being presided over by Matthew Joseph Kacsmaryk.
Kacsmaryk was appointed by Trump in 2019, as was Hendrix.
The U.S. Senate voted 52-46 to confirm Kacsmaryk in June 2019 with Maine’s Susan Collins as the sole Republican to vote against him.
Collins told The Washington Post ahead of the vote that Kacsmaryk had an “alarming bias against LGBTQ Americans and disregard for Supreme Court precedents.”
“Mr. Kacsmaryk has dismissed proponents of reproductive choice as ‘sexual revolutionaries,’ and disdainfully criticized the legal foundations of Roe v. Wade,” Collins said in her statement to the Post. “Such extreme statements reflect poorly on Mr. Kacsmaryk’s temperament and suggest an inability to respect precedent and to apply the law fairly and impartially.”
One of the reasons abortion rights organizations are concerned about this particular case, Dalven said, is because the anti-abortion organizations filing the case went “to extraordinary lengths to get their case before” Kacsmaryk.
She also criticized them for filing the suit, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, just after the November 2022 midterm elections.
The Alliance for Defending Freedom, the anti-abortion legal organization that filed the case on behalf of the anti-abortion medical associations and doctors, said in a written statement released in mid-November the FDA “illegally” approved the prescription abortion medication.
“On behalf of the national health care organizations and physicians we represent, we ask the court to hold the FDA accountable for its reckless, unlawful behavior,” said ADF Senior Counsel Erik Baptist.
Suing ‘over virtually any FDA action’
The U.S. Justice Department argued in its Jan. 13 filing the anti-abortion organizations didn’t have standing “to sue over virtually any FDA action” and criticized the logic they used to argue the doctors could be harmed by the use of abortion medication.
“As Plaintiffs’ argument runs, if FDA approved a new heart medication, emergency physicians would have standing to challenge the approval on the theory that some patients would experience adverse events under the new treatment; in contrast, cardiologists would have standing to challenge the approval on the theory that some patients would no longer require their services,” they wrote.
The federal government also sought to defend the approval of mifepristone in 2000, saying the FDA’s decision followed a comprehensive review of scientific data, which “demonstrated that the drug was safe and effective for abortions under the specified conditions.”
The FDA, the Justice Department lawyers wrote, “reviewed three separate clinical trials involving more than 2,500 pregnant patients, and those trials provided substantial evidence of effectiveness and showed a low rate of serious adverse events.”
“Rather than confront the significant evidence confirming mifepristone’s safety,” the Justice Department lawyers wrote, the anti-abortion organizations filing the lawsuit asked the judge “to second-guess the agency based on five selected publications.”
The FDA, in fact, considered the studies, they wrote.
“None purports to conclude that mifepristone is unsafe. Indeed, three of them expressly endorse mifepristone as a safe treatment,” the Justice Department lawyers wrote. “Moreover, Plaintiffs misconstrue these studies and their relevant findings.”
Biden memo
The White House, on what would have been the 50th anniversary of Roe v. Wade, sought to address the ongoing disputes over abortion medication.
President Joe Biden issued a memo calling on Health and Human Services Secretary Xavier Becerra to consult with the attorney general and the Homeland Security secretary to bolster access to medication abortion.
Biden calls on the three men to consider issuing guidance for people seeking access to mifepristone along with guidance for doctors and pharmacies that plan to continue prescribing or dispensing it.
Biden noted in the memo there “have been reports of efforts to suppress access to medication abortion.”
“State officials have announced that they will impose restrictions to limit access to this evidence-based, safe, and effective medication,” Biden wrote.
He mentioned a letter that 22 state attorneys general sent to his administration that “threatened to enforce State laws that purport to interfere with access to mifepristone.” The states represented included Arkansas, Alaska, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Missouri, Montana, Nebraska, Ohio, South Dakota and Tennessee.
“In Florida, the Governor recently said that major pharmacy chains in the State will not offer mifepristone,” Biden wrote.
“Florida health officials issued guidance discouraging pharmacies from dispensing mifepristone, claiming that State law limits where abortion medication can be provided to hospitals, clinics, or physician offices,” Biden added. “These actions have stoked confusion, sowed fear, and may prevent patients from accessing safe and effective FDA-approved medication.”
