FDA in a legal bind: Two federal judges issue conflicting rulings on mifepristone approval

April 10, 2023

A lot happened last Friday night. Within an hour of each other on Friday evening, two federal judges in two different states issued conflicting rulings in closely-watched cases involving the FDA's 23-year old approval of the medical abortion drug, mifepristone.

First, U.S. District Court Judge Matthew Kacsmaryk in Amarillo, Texas ruled to suspend the FDA’s approval of mifepristone, as well as all recent decisions involving the drug. Then, U.S. District Court Judge Thomas O. Rice in Washington state issued a conflicting order, blocking the FDA from preventing access to mifepristone in the dozen Democratic-controlled states that brought the lawsuit.

While both rulings are preliminary injunctions — temporary decisions that remain until the courts can hear the full cases — the contradictory opinions have set the stage for a protracted legal battle for the U.S. drug regulator as well as ignited industry concerns about the FDA's authority to regulate medicines.

Texas court ruling

The U.S. District Court for the Northern District of Texas’s ruling in Alliance for Hippocratic Medicine et al. v. FDA et al., issued by Trump-appointed judge Matthew Kacsmaryk, granted a preliminary injunction, invalidating the FDA's September 2000 approval of  mifepristone, branded Mifeprex, as well as "all subsequent challenged actions related to that approval — i.e., the 2016 changes, the 2019 generic approval, and the 2021 Actions." This includes the more recent FDA decisions allowing mifepristone to be prescribed via telemedicine, sent by mail and dispensed at retail pharmacies.

The 67-page opinion notes 2002 petitions filed with the FDA challenging the drug's initial approval based on safety concerns, saying the agency "stonewalled judicial review" by  ignoring these petitions. It also claims the agency omitted  "any evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug."

"The Court does not second-guess FDA’s decision-making lightly. 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. There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions," writes Kacsmaryk in the opinion.

But the FDA has stood by mifepristone’s robust, evidence-based approval — a review process that took the agency close to five years to complete — as well as 23 years of safety and efficacy data. Numerous legal advocacy associations, as well as the Biden administration are backing that data as well.

“The harmful order issued out of Texas seeking to suspend the FDA’s approval of mifepristone is a result of extreme, special interest groups continuing their decades-long campaign through the courts to deprive millions of Americans of essential health care," said Skye Perryman, president and chief executive officer for Democracy Forward, in a statement released in response to the Texas ruling. "No court’s decision can negate decades of data affirming the safety and efficacy of mifepristone. We urge all courts to protect access to this essential medication.” 

The Texas ruling will not take effect for a week, giving higher courts time to consider the appeal that was quickly filed by the  Justice Department Friday night.

“If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks,” President Biden said in a White House statement.

Washington state court ruling

The U.S. District Court for the Eastern District of Washington’s ruling, issued by Obama-appointed judge Thomas O. Rice, granted a preliminary injunction, ordering the FDA to "preserve the status quo," blocking the agency from restricting access to mifepristone in the states that filed the lawsuit.

Back in February, attorney generals from 12 states filed the lawsuit against the FDA, seeking that the agency remove the risk evaluation and mitigation strategy (REMS) program from mifepristone. Established in 2007, REMS programs are put in place for certain medications with serious safety concerns to help ensure the benefits outweigh the risks. Out of more than 20,000 FDA-approved drug products, there are only 61 individual and shared REMS programs

The states argued that "all the data shows the mifepristone is among the safest drugs in the world, and safer than the vast majority of drugs for which FDA has never attempted to impose a REMS," questioning why mifepristone is put in the same category as dangerous, addictive opioids like fentanyl.

The states had asked that the court declare that “mifepristone is safe and effective” and that the FDA’s approval of mifepristone is “lawful and valid.” The plaintiffs also asked the court to prevent the FDA from “taking action to remove mifepristone from the market or reduce its availability.”

The court did not go as far as to issue a nationwide injunction — the ruling only applies to the states involved in the lawsuit 

What now?

In the Texas case, the DOJ has already filed an appeal in the U.S. 5th Circuit Court of Appeals. It is possible that the case could eventually make its way to the Supreme Court. 

In the event that court proceedings ultimately rule against the FDA, the agency will start the congressionally mandated process to re-review mifepristone — which could take months to years, during which the drug would stay on the market.

Currently, there are only two drugmakers manufacturing mifepristone for the U.S. market: New York-based Danco Laboratories, which won approval for the branded drug, Mifeprex, in 2000, and Las Vegas-based GenBioPro, which got the nod for the generic tablets in 2019.

GenBioPro, which is not a party in the Texas case but is separately suing West Virginia over the heavy abortion restrictions in place as well as the criminal abortion ban enacted post-Roe, says it will continue manufacturing mifepristone.

"Nothing in the court’s order changes the decades of science and evidence regarding mifepristone’s safety and efficacy. As we review the court’s order, we will continue to make our product available. We will take any steps necessary to lawfully make mifepristone available and accessible to as many people as possible in the country," said Evan Masingill, GenBioPro CEO, in a press statement.

The broader pharma industry has the FDA's back as well. Over 400 biopharma execs signed a letter in support of the FDA’s authority to regulate medicines.

"Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval," the letter states. "Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone."

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'