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It’s hunting season on FDA-approved drugs after Texas abortion pill ruling

Experts warn that the decision to halt sales of an FDA-approved drug based on shaky legal ground will have broad implications.

WASHINGTON (CN) — To bring a suit, the party seeking relief must demonstrate some kind of injury.

But no patient who experienced adverse reactions to mifepristone is part of the group that secured an injunction last week in Texas to block FDA approval of a popular drug used to terminate pregnancies.

U.S. District Judge Matthew Kacsmaryk instead sided with the Alliance for Hippocratic Medicine, which considers the drug harmful and has dedicated resources to advocate against it.

For legal experts taking stock this week, they say the Trump appointee’s ruling subverts an essential judicial doctrine: standing. 

“This is a manufactured set of supposed injured parties that are really just the vehicles for a larger political movement that are waging this battle in federal court,” Katherine Franke, professor of law and director of the Center for Gender & Sexuality Law at Columbia University, said in a phone call.

“The justification for how those doctors are injured … by the presence or the legality of mifepristone is a highly attenuated chain of possibilities that might happen in the future and that is not a sufficient showing of what the law requires in terms of injury,” Franke said. 

No doctor represented by the advocacy group actually administers mifepristone. They instead treat patients who purportedly experienced complications or regret after undergoing medication abortions. Adverse medical reactions to mifepristone usage have been mostly negligible in the decades that it has been on the market. It is among the safest drugs that the FDA has approved.

That agency noted in an amicus brief that, compared with the death rate associated with mifepristone use (five for every 1 million people), the risk of death by penicillin is four times greater. Risk of death by taking the erectile dysfunction drug Viagra meanwhile is nearly 10 times greater.

Alliance for Hippocratic Medicine justified its standing by speculating about a patient who takes mifepristone in the future and has a very rare reaction to the drug. That patient might then come into a hospital where they might be cared for by a doctor in the association. Those doctors then might be able to allege that they were burdened by the patient’s need for care. But no lower court has endorsed this theory of standing before now, to say nothing of the Supreme Court. 

“You essentially are allowing doctors to have a kind of free-floating standing to turn courts into a super FDA that gets to review everything that the FDA has done, not based on principles of administrative law, but just based on the merits of the case,” Frederick Lawrence, a distinguished lecturer at Georgetown Law, said in a phone interview.

While lauded by the religious right, Kacsmaryk's ruling has otherwise stoked outrage from a host of government entities, drug manufacturers and abortion advocates who worry about what it means for abortion access nationwide. Mifepristone — one of two drugs used in medication abortions — has been approved by Food and Drug Administration for over two decades.

“If it stands, it would be open hunting season on FDA-approved drugs,” Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law and Georgetown Law, said in an email about Kacsmaryk's injunction. “For example, red state governors or anti-vax groups could likely challenge the FDA's authorization of COVID-19 vaccines, and that is just the tip of the iceberg. It sets the agency and the nation on a dangerous path.” 

One theory is that the precedent could open the door for medical groups to challenge laws outside of the medication context. 

“An association of doctors could come forward and claim that the federal licensing of firearms is too lax and somebody might get shot in the future because of the lax firearm licensing or policing and that those people who were shot might show up in that doctor's office and then that would push out other patients,” Franke said. 

Mifepristone was approved by the FDA in 2000 and has been by over 5.6 million women in the two decades it's been on the market. Used alongside misoprostol, the drug induces abortions for up to 10 weeks. Around half of all abortions are performed using this method. 

In the 10 months since the Supreme Court decided Dobbs v. Jackson Women’s Health Organization, overturning the federal right to abortions, the resulting spread of abortion deserts has been linked to an uptick in the demand for medication abortions.

“There are plenty of other drugs on the market that are also safe, but less so than mifepristone that a lot of people would be kind of troubled if all of a sudden the FDA approval of those drugs were also challenged, whether it's ibuprofen or penicillin, or even more interestingly for Viagra — which is 10 times more likely to lead to death in people who use it than mifepristone,” Franke said. 

Leaders from over 300 drug companies including Covid-19 vaccine makers Pfizer and Biogen penned an open letter on Monday chastising Kacsmaryk's ruling. Noting that mifepristone is safer than Tylenol, the companies contend that the drug disregarded scientific evidence and legal precedent. 

“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 the new drugs, any medicine is at risk for the same outcome as mifepristone,” the companies wrote. 

Drug companies say the promise of some kind of stability if the FDA approves their drug incentivizes their investment in medications. If a company's drug can be pulled off the market seemingly at random even 20 years after being safely used, they could be less likely to devote their resources. 

The apparent lack of precedent for Kacsmaryk’s ruling aligns with another controversial case on the Supreme Court’s docket this term.

“In an interesting way, it's reminiscent of the standing issue … in the debt relief case,” Lawrence said. “You have people who are using the courts to address what are in fact political decisions made by political branches of government.” 

Lawrence sees a deeper threat from the judicial system being coopted into an attempt to circumvent democratically elected leaders. 

“When you look to the courts to become the way to challenge the merits of a political action that you were not injured by except that you don't like the result, then you're turning the courts into kind of a substitution to the ballot box and that is extremely dangerous,” Lawrence said. 

Follow @KelseyReichmann
Categories / Appeals, Consumers, Courts, Government, Health

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