The fallout from the mifepristone lawsuit that rocked the pharma industry continues on in full force, generating greater attention and questions about its potential long-term impact.
One week after Texas-based Judge Matthew Kacsmaryk ruled against the Food and Drug Administration’s approval of abortion pill mifepristone — the Biden administration and pharma industry are scrambling to mitigate the effects of the decision.
On Thursday, the federal government officially asked the Supreme Court to take emergency action to stop lower courts from enforcing the decision.
Similarly, Danco Laboratories, the maker of the drug, also joined the administration on Friday in asking the Supreme Court to halt any restrictions that may begin to take place as a result of the ruling. Danco noted that the company would be “irreparably harmed” if they take effect.
In court papers, U.S. Solicitor General Elizabeth Prelogar, who is representing the FDA, wrote that “this application concerns unprecedented lower court orders countermanding FDA’s scientific judgement and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone.”
The confusion regarding the fate of mifepristone isn’t solely limited to last week’s ruling. Since then, a number of conflicting rulings have already taken place, resulting in a legal quagmire that is expected to be battled out at the Supreme Court.
Shortly after Kacsmaryk’s ruling, Washington-based Judge Thomas O. Rice ordered the FDA to not make any changes to mifepristone access in 17 Democratic-led states.
On Wednesday, a federal appeals court in New Orleans ruled that mifepristone can remain on the market, blocking the main part of Kacsmaryk’s decision. But the appeals court also allowed other restrictions from his ruling to take place, including halting the FDA’s recent efforts to expand access to the medication.
Those restrictions — even if the drug remains on the market for now — are enough to begin impacting patients in significant ways. The restrictions block the FDA’s rule to allow mifepristone availability until the 10th week of pregnancy as well as the authorization for retail pharmacies to distribute the drug.
The ability for patients to get a prescription via telehealth would also be restricted as patients would be required to set in-person appointments to gain access to the pill.
For anti-abortion advocates, Kacsmaryk’s decision and the resulting appeals court rulings represent victories nearly one year after Roe v. Wade was overturned.
“[W]e’ve got a great victory in the fact that there are now three required doctor visits to make sure women are safe, and the FDA complies with the rule of law,” Erin Hawley, senior counsel for the case at Alliance Defending Freedom, told POLITICO.
Still, the legal saga has only begun and how it turns out remains up in the air.
The requests by the federal government and Danco to the Supreme Court would aim to halt those restrictions enacted by the lower court orders. If the Supreme Court doesn’t take action to stop them, they’ll go into effect by Saturday.
Danco argued that if the order goes into effect, it’ll become “exceedingly difficult, if not impossible” for the drugmaker to continue distributing mifepristone because it would need to update the pill’s labeling, which could take months.
Among healthcare professionals and the pharma industry, the rulings prompted alarm — fueling fears that the impact of the decision could reach beyond abortion.
Hundreds of pharma industry leaders, most notably including Pfizer CEO Albert Bourla, signed a letter that argued Kacsmaryk’s decision “ignores decades of scientific evidence and legal precedent.”
If the ruling should pass, American Medical Association president Jack Resneck said it would create more barriers to care and harm patients and physicians. He added that it would also “exacerbate the maternal mortality crisis, especially for historically marginalized communities.”
However, the legs of the ruling could reach even further than access to abortion. Much of what the pharma industry is concerned about has to do with the ruling creating precedent for future decisions that could challenge FDA approvals of other drugs.
If the ruling passes, it could “open up all sorts of avenues for anyone to challenge any drug that’s associated with anything that’s politically charged,” David Cohen, professor of law at Drexel University Kline School of Law, previously told MM+M.
“There are reasons to be concerned about what this might mean for other reproductive health drugs, gender-related drugs, anything with some political controversy around it,” Cohen added. “If this judge decides to enter the fray, it’s going to open the door for people to invite other judges to do the same thing.”
What happens next will likely be messy and confusing for patients and providers, if the appeals court rulings go into effect Saturday.
While two states — Massachusetts and Washington — have already preventively stockpiled mifepristone, questions around whether doctors can still prescribe the pill will remain. The Supreme Court has until midnight to make a move.
Even with the mifepristone controversy in full flux, some states are continuing to proceed forward with abortion restrictions.
On Thursday night, Florida Governor Ron DeSantis quietly signed a six-week abortion ban into law.
In a tweet, Cohen noted “frankly, this is the biggest abortion news of the week,” given that even with the mifepristone ruling — the option to use another abortion drug, misoprostol, remains available to most patients.
Misoprostol, which is typically used in tandem with mifepristone to induce an abortion, can technically be prescribed on its own for abortions in early pregnancy. It’s used on its own in some countries where mifepristone isn’t available, and it has been deemed relatively safe to do so. Still, research shows it’s not as effective to take misoprostol on its own.
