April 11, 2023

Two separate court rulings throws the future of abortion medication into uncertainty

Matthew Reichbach

Protesters of abortion bans hold signs, including one that lists the Democratic state senators who voted against repealing a 1969 law outlawing abortion in New Mexico, but is currently unenforceable because of the Roe v. Wade decision.

Two conflicting rulings on Friday leave the future use of the abortion medication mifepristone uncertain, though because of one of the rulings, it could remain legal in New Mexico.

There are two rulings in separate states that conflict with one another on the use of the abortion medication mifepristone and the judicial decisions both order the U.S. Federal Drug Administration to act differently with regard to the drug. The ruling made by a Texas federal district judge could force the FDA to remove mifepristone off the market after a seven-day injunction period. But, a ruling also made by a Washington state federal district judge could mean that in 17 states, including New Mexico, the drug would continue to be legally available.

But, with two different rulings provided by two different judges that are in direct conflict with each other, there is considerable uncertainty as to the future of abortion medication, reproductive rights advocates said during a national press conference on Monday. The question of whether mifepristone should continue to be on the market and the conflict between the two cases could wind up at the U.S. Supreme Court for a decision, reproductive advocates said.

No matter what happens, Nancy Northrup, executive director of the Center for Reproductive Rights, said on Monday that the Texas judge’s ruling will likely create chaos for abortion providers and patients.

Abortion medication currently requires a two-step regimen that starts with mifepristone. The drug blocks the hormone progesterone which is necessary for a pregnancy to continue.  

The FDA approved the use of mifepristone in 2000 but also placed it under restricted-use regulations. The FDA has reviewed its safety and effectiveness over the years as part of its restricted use and found it to have a mortality rate of less than 0.001 percent with a 99.6 percent effectiveness and a 0.4 percent rate of complications. But, an anti-abortion advocacy organization sued the FDA in a Texas district court last year, saying that the FDA did not follow proper procedures 23 years ago when it approved the drug and that it has not been studied enough to prove its safety and effectiveness. But reproductive advocates said the drug has been studied more than 100 times across more than 30 countries.

 The judge who decided that case ruled late on Friday, U.S. Judge Matthew Kacsmaryk, a Trump appointee, ruled in favor of the plaintiffs.

Northrup called it a “rogue” case with “no basis in law or fact,” and likened the decision to something out of Lewis Carroll’s novel, Alice Through the Looking Glass.

“The judge is inserting his own analysis on how the FDA should weigh factors in drug approval. It’s completely outside the normal structure of how a court would review such a claim,” she said.

Jenny Ma, senior counsel for the Center for Reproductive Rights, said the judge’s opinion “parrots the language of anti-abortion activists,” and relied on false and misleading information provided by anti-abortion groups.

A second lawsuit begun in the state of Washington, which New Mexico Attorney General Raúl Torrez joined along with 16 other Attorneys General, challenges the FDA’s continued restrictions around the dispensing and prescribing of mifepristone. Although the FDA recently relaxed those rules under the  Biden Administration, some restrictions still apply.

If the Washington state federal district Judge Thomas Rice, an Obama appointee, prevails at the same time as Kacsmaryk’s ruling goes into effect after seven days, then mifepristone could remain legal in New Mexico, Washington, Oregon and the 15 other states that joined the suit, while it is outlawed in states that did not join the lawsuit.

Northrup said the situation is “dynamic” and likely to change over the next seven days. The U.S. Department of Justice has already asked the courts to clarify the tension between the two rulings. The DOJ has also already filed an appeal on the Texas ruling.

But, the appeal will go to the Texas Fifth Circuit Court of Appeals, which has tended to rule conservatively in the past.

Jennifer Dalvan, a reproductive rights attorney with the American Civil Liberties Union, said during the press conference that a side effect of the Texas case is that it could “chill innovation” on pharmaceutical company’s research into forthcoming drugs and “radically alter the process for approving drugs” by the FDA.

Mifepristone is also used at higher dosages to help with Cushing’s syndrome.

Governor Michelle Lujan Grisham issued a statement on Friday after Kacsmaryk’s decision.

“First and foremost: medication abortion remains legal and available in New Mexico. I also want to state, unequivocally, that medication abortion is an effective, safe option, and the Texas decision is an affront to the FDA approval process and the extensive scientific and medical evidence upon which it is based,” Lujan Grisham said in her statement. “I will continue to do all that I can to ensure that New Mexico remains a safe place for women to obtain necessary health care, and I was proud to sign legislation in recent weeks to protect the rights of abortion patients and providers.”  

Torrez’s office also provided a statement about the proven safety and efficacy of mifepristone and said he is “committed to holding the line and will use every tool at my disposal to fight to keep New Mexico a safe haven for those seeking reproductive care.”

The reproductive advocacy group Bold Futures told NM Political Report they wanted to “uplift Plan C,” an online resource for abortion medication. Abortion fund provider Indigenous Women Rising spokesperson Jennifer Lim said “Indigenous communities have always been impacted by any and all restrictions on abortion access; many folks cannot even access the pills now, despite the legality, but we will always have abortions and support anyone who needs or wants them.”

Ellie Rushforth, a reproductive rights attorney with ACLU-NM, said the organization “will be monitoring the litigation out of Texas and Washington as it proceeds through the courts to determine if and how New Mexico will be impacted, and to provide information as we have it.”

“If enacted, this ruling [by Kacsmaryk] will disproportionately impact those who already face the greatest barriers to accessing reproductive health care, including young people, people of color, immigrants, and our rural communities,” Rushforth said.

Northrup said the FDA is already operating under Congressional approval and Kacsmaryk’s decision “upends the authority Congress has already given” the FDA. New Mexico’s congressional leadership, all Democrats, said they opposed the Texas ruling and signed an amicus brief to the U.S. Court of Appeals for the Fifth Circuit calling on those judges to reverse Kacsmaryk’s decision.

Sen. Martin Heinrich’s office said Kacsmaryk “put politics head of science and undermined the FDA’s ability to approve safe and effective medication….”

“I’m a mechanical engineer; I trust science. And the law entrusts the FDA with making scientific evaluations to determine the efficacy of all prescription drugs. Our federal courts need to respect that, too,” Heinrich said.

Sen. Ben Ray Luján said “this ruling escapes common sense.”

“Mifepristone has been an FDA-approved drug for two decades making this plainly an extremist attack on women and trusted, science-backed federal institutions,” Luján said.

U.S. House of Rep. Gabriel “Gabe” Vasquez, who represents the second congressional district, said he “will always stand up for women’s healthcare rights and I will continue to work with my colleagues in Congress to ensure women have the right to choose.”

U.S. House of Rep. Melanie Stansbury, who represents the first congressional district, called the Texas decision “radical, extreme and dangerous.”

“Congress must pass the Women’s Health Protection Act to protect our constitutional right to bodily autonomy, which was undermined by the Dobbs decision in the the Supreme Court last year,” Stansbury said, noting she cosponsored the bill.

This story was updated to reflect that all of New Mexico’s Congressional leadership signed the amicus brief in support of Pres. Biden’s appeal to the U.S. Court of Appeals for the Fifth Circuit.