During the weeklong stay by the Supreme Court to temporarily restore online access to the abortion pill mifepristone after a shock appeals court decision last Friday, scores of experts, industry heavyweights and former regulators have weighed in to defend the availability of the product.
Their contentions, filed in a series of amicus briefs ahead of a Thursday evening deadline, issue stark warnings about the potential fallout if last week’s federal appeals court decision in Louisiana—which briefly prevented mifepristone from being prescribed over the phone and shipped via the mail—is allowed to stand.
The briefs, which also include arguments in support of mifepristone from the likes of PhRMA, more than 250 members of Congress and numerous Democrat-led states, have arrived ahead of the stay’s lift on May 11. Still, the situation could play out in any number of ways come Monday.
The issue is among the latest in a series of attacks on abortion rights in the U.S. under two the Trump terms and specifically revolves around a lawsuit filed in Louisiana that asked to reinstate an FDA requirement for mifepristone prescriptions to be restricted to patients who receive in-person consultations.
The FDA lifted its in-person requirement in 2021 amid the COVID-19 pandemic and then made the decision official in 2023, which dovetailed closely with the Supreme Court’s overturning of the constitutional right to abortion. While the FDA has final say on drug regulation, the state of Louisiana has argued that online availability of the abortion drug mifepristone violates its own 2022 ban on the procedure.
After the initial ruling in a New Orleans court dealt a significant blow to the pill’s access last Friday, mifepristone manufacturers Danco and GenBioPro filed an emergency request to overturn the decision, leading to the temporary pause that has held through the past week. In its filing last weekend, GenBioPrio had argued that the decision of the appeals court’s three-judge panel had “unleashed regulatory chaos.”
That sentiment was echoed in one of the briefs filed (PDF) by nine former commissioners and acting commissioners at the FDA, including Janet Woodcock, M.D., and Robert Califf, M.D., in support of Danco and GenBioPro’s position.
In their argument to the Supreme Court, the former commissioners argue that the FDA was “extremely cautious in approving mifepristone and subsequently modifying its [risk evaluation and mitigation strategies], and that the agency’s adjustments to the drug’s postmarketing restrictions in 2021 and 2023 were based on 20 years of adverse event reporting and a thorough review of the literature.”
They contended that the appeals court’s approach would “upend FDA’s gold-standard, science-based drug approval system,” further warning that the ruling “creates a roadmap for attacks on science-based drug regulatory decisions.”
NPR and some industry watchers have noted that it’s bizarre that the FDA itself hasn’t taken a position on the ruling, given the potentially major implications on the power of its federal authority over drug product regulations.
The industry’s most prominent U.S. trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), is also taking a stand in defense of mifepristone access, arguing (PDF) that the risk inherent in the hundreds of billions of dollars invested in U.S. innovation is only “tolerable” to companies because of the “reliability and scientific rigor in the process for drug approvals and post-approval determinations.”
The appeals court’s decision restricting mifepristone access undermines that rigor and reliability, they argue. If the ruling is not stayed or vacated, it could set a precedent with the potential to “significantly disrupt the biopharmaceutical industry, harm patients, and stifle innovation in drug development,” PhRMA cautioned in its brief.
The feeling was mutual among food and drug law scholars and professors with less direct ties to the industry, too.
In a brief from multiple such experts seeking to stay the appeals court ruling, the regulatory academics issued a scathing rebuke of the Fifth Circuit’s order, which they argued “rests on critical misunderstandings of federal food and drug law, the regulatory history of mifepristone, and the evidence relied on by FDA.”
The decision by the agency to remove its in-person dispensing requirement for mifepristone was “measured, science-based, well-documented, and consistent” with relevant law designed to help the FDA minimize burdens on patients and health systems, the scholars added.
Outside the industry, lawmakers and a coalition of Democrat-led states further pressed the issue, falling back more broadly on the separation-of-powers arguments and the legal justifications behind the ruling in Louisiana.
In a brief submitted (PDF) by 259 members of Congress—including 47 U.S. Senators and 212 members from the House of Representatives—the lawmakers suggested that they have a “special interest in both upholding the Constitution’s separation of powers—including ensuring that federal administrative agencies faithfully exercise the authorities Congress delegated to them in accordance with statutory limits—and protecting the physical health and safety of their constituents.”
They called for the Supreme Court to grant an emergency stay or vacate the lower court’s decision, suggesting that the ruling has “no basis in law” and “threatens the congressionally-mandated evidence-based process for drug-regulatory decisions.”
As for the states’ brief—which lists New York, Arizona, California, Hawaii, Illinois, North Carolina, New Jersey, Virginia and Washington among its backers—the argument against the Fifth Circuit’s ruling relies on claims that the decision is “legally erroneous, creates regulatory and administrative chaos nationwide, and undermines the ability of millions of people to access lawful medical care.”
The amici states added that telehealth dispensing of medication abortion has been crucial in improving access to the service for their residents, and especially for those in low-income, underserved and rural communities, which they note experience “higher rates of birth-related mortality and morbidity” and where healthcare access is generally more limited to begin with.
The latest controversy around mifepristone comes after the Fifth Circuit in April of 2023 moved to prohibit the pill’s delivery by mail, as well as to restrict the timeframe it could be used during pregnancy from 10 to 7 weeks. But the following June, the Supreme Court preserved access to the pill via telemedicine.
Mifepristone was originally approved in 2000 and works by blocking the hormone progesterone, which is needed for a pregnancy to continue. The drug is often used in tandem with another product called misoprostol, which helps induce contractions.
While the Supreme Court could weigh in on the issue Monday, it is possible that the pause on telemedicine mifepristone orders could extend beyond the early next week deadline as the situation plays out, Stat reported Friday.
