Nevada drugmaker joins legal effort to fight rollback of abortion pill rules

Editor's note: Este artículo está traducido al español.

GenBioPro, the Nevada pharmaceutical company that makes and distributes a generic version of the medication abortion drug mifepristone, has joined the Food and Drug Administration in a lawsuit to protect access to the drug that’s become a major method of ending a pregnancy in the United States.

Their opponents, attorneys general from Missouri, Kansas and Idaho, are looking to roll the clock back to 2016 by reversing nearly a decade of FDA rulemaking.

Those Republican attorneys general want to limit the time frame people can use the drug, mandate follow-up visits, require people to pick up the drug in person and kill the generic version that GenBioPro distributes.

“We remain concerned about extremists and special interests’ attempts to undermine the U.S. Food and Drug Administration’s regulatory authority,” GenBioPro CEO Evan Masingill wrote in a statement. “GenBioPro remains committed to using all legal and regulatory tools to protect mifepristone.”

But what seems like a common goal between the FDA and GenBioPro, which is the sole U.S. manufacturer of generic mifepristone, may not last long.

Robert F. Kennedy Jr., President Donald Trump’s pick to run the Department of Health and Human Services, which oversees the FDA, said at his confirmation hearing that the president wanted him to look into the drug’s “safety issues.”

“Trump has not yet taken a stand on how to regulate it,” Kennedy said. “Whatever he does, I will implement those policies.”

And on March 3, the FDA’s legal team at the Department of Justice rationalized a request to push back a court deadline by writing to the judge that it would “ensure that the new administration … is able to familiarize themselves with the issues in this case.”

A day later, Judge Matthew Kacsmaryk accepted the request, meaning the FDA’s next reply brief is due May 5.

Dr. Laura Schummers, a reproductive epidemiologist at the University of British Columbia, took issue with the notion that mifepristone was fraught by “safety issues.” Schummers studied the drug’s quick introduction in Canada and found no increase in abortion complications in the province of Ontario.

“It is incredibly clear that mifepristone is a safe medication,” she said, adding later that “there have been many studies already on the safety and efficacy of mifepristone.”

In U.S. trials, the drug, one half of the abortion pill regimen, resulted in a successful abortion over 97% of the time, according to the FDA.

Macy Haverda and her organization, the Wild West Access Fund of Nevada, have followed the case since before last year’s decision. The fund financially supports people looking to access abortion across the country and sometimes works with organizations that mail abortion pills.

“I have no idea why (mifepristone’s safety) has become the thing that they’re obsessing over except that it may be that it’s easier to fight than fighting states like Nevada that have laws in place that allow people to have access to abortion care,” Haverda said.

The FDA is arguing that the case should be transferred or dismissed since it’s being heard in Texas, outside of the three states’ jurisdiction. But the current case is just an extension of one decided by the Supreme Court last year.

In a win for reproductive rights advocates, the Supreme Court ruled in June that the Alliance for Hippocratic Medicine, an anti-abortion group incorporated in Texas that was a plaintiff in the case, could not demonstrate impact since none of the doctors in the alliance had prescribed mifepristone.

Now, the attorneys general are carrying their mantle, only dropping the complete removal of Mifeprex, the name brand version of mifepristone, from the alliance’s arguments.

Along with RFK Jr.’s comments at his confirmation hearing, the new administration has struck a cold attitude toward abortion.

Earlier this month the administration dropped a Biden-era lawsuit challenging Idaho’s complete abortion ban, arguing that it violated federal law guaranteeing lifesaving, “stabilizing” care at hospitals that receive Medicaid funding.

New U.S. Attorney General Pam Bondi also gave a warm response to a Louisiana district attorney looking to prosecute a New York doctor for sending abortion pills to the state.

Tony Clayton, the district attorney behind the case, told Bondi that he needed her help and that he would “like to see some consistency around the country (so) that states just can’t harbor fugitives away from folks down here in Louisiana.”

“I would love to work with you,” she responded.

Dr. Marty Makary, Trump’s pick to lead the FDA, refrained from giving his own thoughts on mifepristone when pressed by Democrats at his confirmation hearing.

“I have no preconceived plans on mifepristone policy except to take a solid hard look at the data and to meet with the professional career scientists who have reviewed data at the FDA, and to build an expert coalition to review the ongoing data,” Makary said.

And what was supposed to be one of the bright spots for pro-choice activists was quickly dimmed last week.

The FDA announced Tuesday that Hilary Perkins, who previously represented the FDA in another case related to abortion pills under President Joe Biden, would be its top lawyer. But by early Thursday morning, the FDA posted on social media that she had resigned.

While the Trump administration has been accused of overstepping its boundaries, changing positions on ongoing litigation is commonplace when a new presidential administration comes in, said David Orentlicher, a professor at UNLV’s Boyd School of Law and a Democrat in the Nevada Assembly.

At the start of the Biden administration, the federal government changed its position on the Affordable Care Act, switching sides to uphold the law — the exact opposite of what the first Trump administration had argued earlier in court.

“What’s different is that the Trump administration is taking so many radical positions,” said Orentlicher, referencing an executive order stating that executive agencies should be accountable to the president.

“When you’re dealing with medical decisions, you don’t want politics to drive it,” he said.

Carrie Flaxman, senior adviser at legal advocacy group Democracy Forward and part of GenBioPro’s legal counsel, said that “if you take a look at what Project 2025 has been urging, it’s clear that we need to be concerned that the new administration will take action against abortion.”

Project 2025 is the conservative Heritage Foundation’s sweeping proposal, written prior to the 2024 presidential election, that provided a blueprint for action for the next Republican president. Despite heavy input from numerous members of Trump’s first administration, Trump himself disavowed the blueprint during the campaign. But he now has embraced many of its recommendations.

The FDA did not respond to multiple requests for comment.

“We will continue to track what this administration is doing with respect to this case and more generally with respect to regulation of this medication and, where appropriate, take action … to make sure that the drug remains on the market,” Flaxman told the Sun.