A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifepristone.
The signatories include biotechs Arsenal Biosciences, C4 Therapeutics, Nkarta, ReCode Therapeutics and Trace Neuroscience, among numerous others. The companies are joined by investment firms like RA Capital Management and Samsara Biocapital, as well as individuals like Big Pharma vet and Revolution Medicines board member Flavia Borellini, Ph.D., Vertex Ventures’ managing director Lori Hu and Architect Therapeutics CEO Angie You, Ph.D.
“FDA-approved drugs should not be subject to judicial recall. When FDA determines that a drug is safe and effective, clinicians and patients should have access on those terms,” the brief states. “Plaintiffs’ attack on FDA’s well-founded scientific judgment would wreak havoc on the American pharmaceutical and biotech industry.”
Louisiana sued the FDA in October 2025 seeking to challenge the agency’s 2023 determination that mifepristone, a medication commonly used for medical abortions as well as for contraception and to treat the rare disease Cushing’s syndrome, can be mailed to patients. The state alleges that this effectively prevents abortions from being banned in Louisiana, as patients can have mifepristone prescribed through telehealth appointments and delivered to them from across state lines.
While a district court in western Louisiana originally paused the case to allow the FDA time to review mifepristone’s safety, a panel of three Fifth Circuit judges ruled to block mailed mifepristone access nationwide while the litigation continued. This decision was ultimately reversed by the Supreme Court in May, allowing patients access to the pill via mail once again for the time being.
The ruling kicked the case back down to the lower courts, where it is ongoing, and the FDA has since launched its investigation of mifepristone, which is already known to be safe and effective.
In the new amicus brief, the chief concern for the biotech industry is not mifepristone access per se, but the precedent that would be set if a scientific determination by the FDA was undermined by a lawsuit.
“What the Louisiana suit is all about is a political intrusion by people who have decided that they know better than the FDA as to what a drug should be and not,” Jeremy Levin, Ph.D., former CEO of Teva Pharmaceuticals and chairman emeritus of the Biotechnology Innovation Organization, told Fierce.
“The only beneficiaries of this would be a small, malicious group of people who have a political agenda and are misusing the courts,” Levin added, “where the courts should be spending their time on other things of far greater consequence and that are within their purview.”
Should Louisiana succeed in its suit against the FDA, the consequences would be difficult to fully fathom, Levin said. There is potential for it to lead to spurious lawsuits popping up to challenge all kinds of FDA decisions, he suggested. Biopharma companies, in turn, would have to prepare for such challenges, making it “chaotically impossible” to approve drugs.
If political opposition to weight loss drugs crops up, for example, “then we can be assured that somebody will file suit” to try to take them away, Levin speculated. “This is not about mifepristone—this is about freedom of access to scientifically proven medicines.”
The new amicus brief follows several others filed in support of the FDA and mifepristone during the case, including from: PhRMA; more than 250 members of Congress; numerous Democrat-led states; and nine former commissioners and acting commissioners at the FDA, including Janet Woodcock, M.D., and Robert Califf, M.D.
Biotech leaders also rallied behind mifepristone in June 2025, after the FDA’s plans to review the drug’s safety were first sparked by a think tank report that detractors deemed “fatally flawed.”