A Supreme Court case over whether to tighten restrictions on mifepristone – one of two drugs used in the medication abortion regimen – could destabilize the American pharmaceutical industry, deterring companies from developing new drugs and even inspiring copycat lawsuits intended to revoke authorization of other politically contentious medications.

Drug and biotech companies have been sounding the alarm, arguing that a decision restricting access to mifepristone will have implications for a wide array of medications and devices, including but not limited to intrauterine devices, HIV prevention pills, emergency contraception and vaccines.

“A precedent’s been set,” said Dr. Amanda Banks, the managing director of Banks Advisory, which works with companies to develop therapeutics. “This can apply to any drug, any device, any diagnostic, any vaccine.”

The case, set to be heard March 26, concerns whether the U.S. Food and Drug Administration erred in a 2016 decision that expanded when and how mifepristone can be used. That decision allowed doctors to prescribe it at up to 10 weeks of pregnancy, rather than seven, and to prescribe it during online visits and ship it through the mail, rather than requiring in-person appointments. The court declined to hear an even broader challenge, in which a coalition of anti-abortion doctors had argued that the agency’s original approval of the drug in 2000 should be blocked.

The FDA itself has reversed its own approval for drugs: Last year it revoked its authorization of Makena, which had initially received approval under a special expedited pathway and was believed to lower the risk of preterm birth. But there is no precedent for the courts overriding the agency, which is known globally for its scientific rigor. The decision to approve mifepristone in the United States took several years and came after the drug was already available in many other countries. 

Though the question the court will hear is relatively narrow — focusing on the 2016 decision to expand the circumstances of mifepristone’s use, rather than its actual approval — a ruling against the FDA could send shockwaves through the industry if similar suits target the authorization of other highly-politicized drugs or medical devices.

Former government officials and industry veterans are particularly concerned about efforts to reverse the approvals of vaccines, especially after the partisan backlash to COVID-19 shots, and data suggesting an increase in vaccine skepticism more broadly. Industry veterans have suggested potential risks to intrauterine devices, which anti-abortion activists inaccurately characterize as abortifacients. Five IUDs are available in the United States. The oldest, the copper Paragard, was approved in 1988. The newest product, a hormonal IUD called the Kyleena, received FDA approval in 2016.

But the implications could be even further-reaching, some pharmaceutical executives argued. If the court rules against mifepristone, other cases will “rapidly arise,” said Jeremy Levin, the CEO of Ovid Therapeutics, which develops treatments for neurological conditions.

“If the court can override any decision of any agency, but particularly a health and safety agency, then we don’t have a situation with just mifepristone,” said Elizabeth Jeffords, CEO of Iolyx Therapeutics, which focuses on ophthalmology and autoimmune diseases. “It doesn’t matter what the drug is. If this precedent is set, we’ll see a lot of litigation around medications that are considered more ‘political’ — that could be anything from womens’ health to gender-affirming care to lifestyle drugs, and maybe you count Viagra in there.”

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A court decision that undermines an FDA approval could also chill biotech and medical innovation. The potential reward of approval — which essentially guarantees several years of exclusive sales — offers a critical incentive for companies to pursue risky and expensive drug development. 

“Companies that invest in developing potentially lifesaving drugs must be able to rely on courts to respect FDA’s expert scientific judgments. If a court can overturn those judgments many years later through a process devoid of scientific rigor, the resulting uncertainty will create intolerable risks and undermine the incentives for investment regardless of the drug at issue,” wrote Jeffords, Levin, Banks and other pharmaceutical executives in an amicus brief submitted to the Supreme Court in the case, known as Food and Drug Administration (FDA) vs. Alliance for Hippocratic Medicine. 

If companies suspect that FDA approval can be reversed through litigation — rather than because of newfound clinical data — they will feel less secure investing resources in developing new drugs, said Jim Stansel, an executive vice president for the Pharmaceutical Research and Manufacturers of America, an influential lobbying and trade group. 

“The gold standard of FDA review and approval gives our members the predictability they need to bring innovative new medicines to patients,” Stansel said.

The threat to the drug industry at large depends not only on how the court rules, but what rationale it cites. If the court overrules the FDA’s 2016 decision, it could find that the agency did not adequately consider the risks of mifepristone, a decision that would have potential implications for an array of pharmaceuticals. 

But it could also rule based on an 1873 anti-obscenity law known as the Comstock Act, which prohibits the mailing of materials “intended for producing abortion, or for any indecent or immoral use.” Although it has not been enforced in decades, the organization challenging the FDA has argued that the agency’s expansion of mifepristone’s approval is invalid because it runs contrary to that law.

A ruling focused on the Comstock Act might help build case law that could be used to restrict access to forms of birth control, such as IUDs, or to emergency contraception. But the specificity of its anti-abortion provisions means it would likely have far fewer implications for the drug industry at large, said Greer Donley, an associate professor of law at the University of Pittsburgh. For example, it likely wouldn’t apply to drugs unrelated to sexual health, such as vaccines.

“If the court says something like, ‘Well we’re going to invalidate the FDA’s decision to remove the in-person dispensing requirement [for mifepristone] because there’s not enough evidence of safety and efficacy,’ that puts a target on the back of the FDA,” she said. “If it’s about Comstock, that’s different because it doesn’t directly implicate other products in the same way.”