While the Supreme Court put on hold for a week to temporarily restore online access to the abortion drug mifepristone following last Friday’s shocking Court of Appeal ruling, a number of experts, industry executives and former regulators weighed in to defend the product’s availability.
Their arguments, filed in a series of court briefs ahead of Thursday night’s deadline, issue stark warnings about the potential impact if last week’s Louisiana federal appeals court ruling that temporarily banned mifepristone from being prescribed over the phone and shipped by mail is left in place.
The brief, which also includes advocacy for mifepristone from PhRMA and other members of Congress, more than 250 members of Congress, and many Democratic-led states, arrived ahead of the May 11 stay lifting. Still, the situation could play out differently by Monday.
The issue is one of the latest in a series of attacks on abortion rights in the United States under the Trump administration’s two terms, particularly revolving around a lawsuit filed in Louisiana seeking to reinstate the FDA’s requirement to limit prescribing of mifepristone to patients receiving in-person visits.
The FDA lifted the in-person requirement in 2021 amid the coronavirus pandemic, then made a formal decision in 2023, which closely aligned with the Supreme Court’s overturn of the Constitution’s right to abortion. Although the FDA has the final say on drug regulations, Louisiana claims that the online availability of the abortion drug mifepristone violates the state’s 2022 ban on abortion procedures.
Last Friday, after an initial ruling in a New Orleans court dealt a significant blow to the pill’s availability, mifepristone manufacturers Danko and GenBiopro filed an emergency request to overturn the decision, and the moratorium lasted until last week. GenBioPrio argued in a filing over the weekend that the three-judge Court of Appeals panel’s decision “created regulatory confusion.”
This opinion is reflected in one of the briefs (PDF) filed by nine former FDA commissioners and acting commissioners, including Janet Woodcock, MD, and Robert Khalif, MD, in support of Danko and GenBiopro’s position.
In their argument to the Supreme Court, the former commissioners argued that the FDA was “very cautious in approving mifepristone and subsequently changing its (risk assessment and mitigation strategies), and that FDA’s adjustments to the drug’s postmarket restrictions in 2021 and 2023 were based on a thorough review of 20 years of adverse event reports and literature.”
They argued that the appellate court’s approach “undermines the FDA’s gold standard science-based drug approval system,” and further warned that the decision “creates a roadmap for attacks on science-based drug regulatory decisions.”
NPR and some industry watchers have noted that it is strange that the FDA itself has not taken a position on the ruling, given its potentially significant implications for the federal agency’s authority to regulate drugs.
The industry’s most prominent U.S. trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), has also defended access to mifepristone, arguing that the risks inherent in the hundreds of billions of dollars invested in U.S. innovation are only “acceptable” by companies because of the “trustworthiness and scientific rigor of the drug approval and post-approval decision-making process” (PDF).
They argue that the Court of Appeal’s decision to restrict access to mifepristone undermines its rigor and credibility. If the ruling is not blocked or reversed, it could set a precedent that could “significantly disrupt the biopharmaceutical industry, harm patients, and stifle innovation in drug development,” PhRMA warned in a prepared statement.
This sentiment was echoed among food and drug law scholars and professors with fewer direct ties to industry.
In a brief from several experts seeking to uphold the Court of Appeals’ decision, regulatory scholars blasted the Fifth Circuit’s order, arguing that it was “based on a material misinterpretation of the federal Food and Drug Act, mifepristone’s regulatory history, and the evidence relied upon by FDA.”
The agency’s decision to eliminate the in-person dispensing requirement for mifepristone is “prudent, science-based, well-documented, and consistent” with related legislation that FDA aims to minimize burden on patients and the health care system, the scholars added.
Outside the industry, lawmakers and a coalition of Democratic-led states pursued the issue further, addressing separation of powers issues and the legal rationale behind the Louisiana ruling more broadly.
In a brief (PDF) filed by 259 members, including 47 members of the U.S. Senate and 212 members of the U.S. House of Representatives, the lawmakers suggested they have a “special interest in both defending the Constitution’s separation of powers, including ensuring that federal executive agencies faithfully exercise the powers delegated by Congress, subject to statutory limitations, and protecting the physical health and safety of their constituents.”
They asked the Supreme Court to grant an emergency stay or vacate the lower court’s decision, suggesting the decision was “without legal basis” and “threatened the evidence-based drug control decision-making process mandated by Congress.”
As for the state brief, which counts New York, Arizona, California, Hawaii, Illinois, North Carolina, New Jersey, Virginia, and Washington as its supporters, the argument against the Fifth Circuit’s decision relies on the argument that the decision is “legally wrong, creates regulatory and administrative chaos nationwide, and impairs the ability of millions of people to obtain lawful health care.”
The court added that dispensing abortion pills via telemedicine is critical to improving access to services for populations, particularly those in low-income, underserved, and rural areas, where “birth-related mortality and morbidity rates are high” and where access to health care is generally more limited to begin with.
The latest controversy over mifepristone comes after the Fifth Circuit moved in April 2023 to ban the pill from being delivered by mail and limit its use during pregnancy from 10 weeks to seven weeks. But the following June, the Supreme Court upheld telemedicine access to the pill.
Mifepristone was first approved in 2000 and works by blocking the hormone progesterone, which is necessary for a pregnancy to continue. This drug is often used in conjunction with another product called misoprostol, which helps induce contractions.
The Supreme Court is likely to consider the issue on Monday, but depending on how the situation develops, the suspension of telemedicine orders for mifepristone could be extended beyond the deadline early next week, Statistic reported on Friday.
