The Anti-Abortion Movement Just Made a Powerful New Enemy

Mark Joseph Stern / Slate
The Anti-Abortion Movement Just Made a Powerful New Enemy The movement's latest gambit is turning into a grievous tactical error. (photo: Evelyn Hockstein/Reuters)

The mifepristone decision has awakened a sleeping giant.

For decades, the pharmaceutical and biotech industry tried to avoid the politics of abortion. On Friday, that strategy came to a crashing halt. U.S. District Judge Matthew Kacsmaryk’s lawless and unprecedented decision ordering the Food and Drug Administration to revoke approval of mifepristone, the first drug in a medication abortion, poses an existential threat to the entire industry: If upheld, the order would allow any doctor to file a lawsuit compelling the FDA to revoke approval of any drug they dislike. If any such suit succeeds, a single, handpicked judge could overrule the FDA’s scientific determinations and issue a nationwide block on that medication. The drug need not have anything to do with reproductive health: vaccines, antibiotics, antidepressants, hormones, statins, painkillers—all are vulnerable under Kacsmaryk’s decision.

Put simply, the battle against abortion has landed squarely on the doorstep of the biotech and pharma (biopharma) industry. And after evading the issue for so long, the industry leapt into action over the past five days: Nearly 600 executives (and counting), including some of the most prominent players in the field, have signed a scathing letter criticizing Kacsmaryk’s ruling as unscientific “judicial activism” that puts “an entire industry focused on medical innovation at risk.” Their letter demands the swift “reversal of this decision,” noting that it puts “any drug” at risk of “the same outcome.” An amicus brief filed on behalf of biopharma heavyweights (including Pfizer) similarly warns that the decision will “result in a seismic shift in the clinical development and drug approval processes, erecting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing the pharmaceutical industry.”

This reaction suggests that the anti-abortion movement has made a grievous tactical error: In its reckless quest to obtain a nationwide block on mifepristone, the movement has awakened a sleeping giant, turning biopharma into an extremely well-funded and politically connected foe. That tectonic shift has major implications not only for this particular case, but for the right’s broader efforts to use the courts as a shortcut to a 50-state abortion ban. Abortion rights advocates just gained one of the most powerful corporate allies in the country.

Even though medication abortion was approved in 2000, most biopharma companies want nothing to do with it. For 19 years, just one drugmaker, Danco Laboratories, manufactured the medication for termination of pregnancies; only in 2019 did one other company bring a generic version to market. The drug industry has largely avoided advocacy around abortion rights, but that tactic is no longer possible. For decades, FDA approval has served as the global gold standard of scientific review; now a lone judge has undermined its authority, abolishing the agency’s longtime role as the final arbiter of which drugs are safe and effective.

To see why Friday’s decision imperils the entire biopharma field, start with Kacsmaryk’s attempt to establish standing for the plaintiffs, a group of anti-abortion doctors. To sue in federal court, the Constitution requires plaintiffs to establish a “concrete and particularized” injury that is “actual or imminent.” To meet these requirements, the doctors in Kacsmaryk’s case said they might treat a future patient who is injured by mifepristone that’s prescribed by someone else. That’s a totally speculative and generalized injury—the opposite of “concrete” and “imminent.” Incredibly, Kacsmaryk still embraced this theory of standing, brazenly defying binding Supreme Court precedent in the process.

By doing so, he set off alarm bells for every drug manufacturer in the country. Why? Because his theory has no limiting principle: It opens the floodgates to nonstop lawsuits against FDA-approved medicines. Imagine, for instance, that Doctor A gives the COVID vaccine to his patient. The patient suffers side effects and goes to Doctor B for treatment. According to Kacsmaryk, Doctor B can now walk into federal court and ask for an order revoking FDA approval of the COVID shot. If the judge agrees, he can single-handedly issue a nationwide block on the shot.

Actually, it’s even worse: In this scenario, Doctor B does not even have to treat a patient who suffered side effects from the vaccine. They need only claim that they may one day have to do so. And that, per Kacsmaryk, is enough to establish standing.

The exact same scenario could play out with any other drug, but controversial treatments would be most vulnerable. For example, Republicans are currently taking aim at PrEP, an extremely effective HIV prevention drug that’s commonly prescribed to gay and bisexual men, longtime targets of the GOP’s ire. Under Kacsmaryk’s theory, an anti-gay doctor could stroll into federal court and ask a judge to revoke the FDA’s approval of PrEP because, at some point in the future, they might treat a PrEP user who suffers side effects. Rinse and repeat with any drug under fire: hormones and puberty blockers prescribed for gender-affirming care; emergency contraception and birth control pills; the HPV vaccine (which Republicans are also assailing in court)—the list goes on.

In truth, no drug would be safe: Innovative new therapies frequently draw challenges from fringe groups that allege some conspiracy in the approval process. (Just look to the anti-vax fervor of the past few years.) In fact, Kacsmaryk’s ruling against mifepristone itself rests in part on a conspiracy theory about the FDA. There will always be someone eager to challenge a new drug in court. And, sadly, there are plenty of fringe doctors willing to play their part in such a scheme. That’s why, as industry leaders explained, “the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines.”

All that said, this strategy only works if the plaintiffs can persuade a judge that the FDA erred so grievously in approving a drug that a court must overturn its decision. Before the mifepristone case, such a power grab was unthinkable; never before in history had a judge claimed the authority to revoke FDA approval of a medication. Judges are not scientists or doctors, and they lack the competence to second-guess an expert agency.

Yet Kacsmaryk blew past this limitation, too: The judge ignored nearly 150 studies proving that mifepristone is extremely safe and instead relied upon anonymous blog posts on an anti-abortion website to argue that the drug is, in fact, dangerous and under-regulated. If allowed to stand, his decision sets a new precedent allowing any judge to overrule the FDA’s judgment by disregarding the science behind its decisions.

It gets worse. Kacsmaryk fabricated stringent new rules for clinical trials, requiring many drugs to undergo “head-to-head” trials that directly compare two different treatments. The judge just made this up: No statute or regulation requires such trials, and the FDA has always accepted many different kinds of studies. Kacsmaryk also concocted draconian new labeling rules and reporting requirements: Perversely, he barred label updates that reflect new research and FDA consideration of crucial safety information reported by drugmakers. As the biopharma amicus brief explains, this anti-scientific approach would “chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development and approval generally, causing widespread harm to patients, providers, and the entire pharmaceutical industry.”

No wonder, then, that the Biotechnology Innovation Organization—the largest advocacy group representing the international biotech industry—scorned Kacsmaryk’s “dangerous” decision for “undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies.” Or that Jeremy Levin, CEO of Ovid Therapeutics, called the ruling “one of the greatest threats to drug approvals in the last 50 years.” Or that the leaders of Pfizer, Biogen, and hundreds of other companies signed onto the letter repudiating the ruling. The vast majority of these companies have no direct connection to abortion-related medicine. But they understand that the assault on mifepristone has become an assault on their ability to function.

In 2022, biopharma spent about $374 million in lobbying efforts. A huge amount of its campaign contributions go to Republican candidates. It’s far too soon to say whether the mifepristone disaster will prompt companies and trade groups to send their money to candidates who do not think the judiciary should replace the FDA’s judgment with its own.. But this case has forced executives to recognize that the anti-abortion movement will gladly declare war on biopharma to curb reproductive rights. The movement may come to regret its rash decision to pick a fight with a multitrillion dollar pillar of international medicine.

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