The battle over the abortion drug mifepristone has taken on a heightened level of importance in light of conflicting legal rulings issued Friday evening.

As many expected, Judge Matthew Kacsmaryk of the Northern District of Texas issued a preliminary ruling in Alliance for Hippocratic Medicine v. U.S. FDA, invalidating the Food and Drug Administration’s approval of mifepristone. 

Kacsmaryk heard oral arguments earlier this month that asserted the FDA’s approval of the pill in 2000 was unlawful and ignored evidence that the medication was unsafe in subsequent reviews.

“The Court does not second-guess FDA’s decision-making lightly,” he wrote in his ruling. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.” 

In response to Kacsmaryk’s decision, the Department of Justice, FDA and Danco Laboratories, which manufactures the drug, filed notices of appeal with the Fifth Circuit Court of Appeals. Attorney General Merrick Garland added that he plans to appeal the ruling.  

Meanwhile, Judge Thomas O. Rice of the Eastern District of Washington, ordered U.S. authorities Friday evening to not make any changes that would hinder access to mifepristone in 17 Democratic-led states that sued over the issue.

In light of an uncertain future for mifepristone, it’s important to note that Rice’s ruling essentially maintains the status quo of the drug for now.

Going forward, the Kaiser Family Foundation said that if the Fifth Circuit Court doesn’t hear the appeal of the case, it’s likely that it would be appealed to the Supreme Court immediately. KFF added that the Supreme Court, which currently has a 6-3 conservative majority, could review both the Texas and Washington cases together.

David Cohen, professor of law at Drexel University Kline School of Law, told MM+M earlier this month that the drug’s fate is marred by a complicated legal road ahead. Still, he added that Kacsmaryk’s ruling wouldn’t be the end of the line.

“Just because the approval is withdrawn, it doesn’t mean we’re suddenly going to see this drug disappear in clinics,” Cohen said. “There are a lot of other steps that have to be taken, with a lot of other actors taking them.”

The mifepristone controversy, which takes place nearly a year after Roe v. Wade was overturned, sparked an intense reaction among industry stakeholders as some speculate that abortion rights could be further restricted.

Notably, Pfizer CEO Albert Bourla signed a pharma industry letter supporting the FDA’s authority to regulate medicines in light of the decisions handed down Friday evening.

Several prominent pharma and biotech leaders signed the letter, including Nkarta Therapeutics CEO Paul Hastings, Biogen President Alisha Alaimo, Merck executive Christopher Tan and Jazz Pharmaceuticals COO Daniel Swisher, among others.

PhRMA also offered its thoughts on the situation, calling the FDA the “gold standard for determining whether a medicine is safe and effective for people to use.”

The ruling generated widespread condemnation by Democratic lawmakers on Capitol Hill as well as from President Joe Biden and Vice President Kamala Harris. However, Republicans have largely remained quiet on the Texas decision, with only Sen. Cindy Hyde-Smith (R-Miss.) tweeting a celebration of the ruling Friday night.

For its part, Planned Parenthood published a blog following the ruling to remind patients that depite whatever happens to mifepristone, another abortion drug misoprostol, is still safe, effective and available for use.

Additionally, Jack Resneck Jr., MD, president of the American Medical Association, issued a statement criticizing the Texas ruling and its broader implications for the U.S. healthcare industry.

“Today’s court decision from a federal district court in Texas staying longstanding approval of mifepristone flies in the face of science and evidence and threatens to upend access to a safe and effective drug that has been used by millions of people for more than 20 years,” he said. “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation.”

For a March 2024 article on what the Supreme Court’s mifepristone hearing could mean for pharma, click here.