Biotech Executives and Investors Urge FDA to Preserve Access to Mifepristone Amid Legal Uncertainty
A group of leading biotechnology executives, investors, and scientific experts are urging the U.S. Food and Drug Administration (FDA) to safeguard continued access to mifepristone, a medication commonly used in medication abortions and miscarriage management. In a public letter addressed to the agency, signatories emphasized the importance of upholding the FDA’s authority and scientific independence in the face of ongoing legal challenges that threaten to restrict access to the drug.
Mifepristone, approved by the FDA in 2000, is used in combination with misoprostol for medication abortions, which now account for more than half of all abortions in the United States. The drug has a long-established safety and efficacy record backed by two decades of use and numerous clinical studies. However, recent legal battles, including a case that reached the U.S. Supreme Court, have put its availability at risk, prompting leaders in the life sciences sector to voice their concerns.
The letter, coordinated by the biotech advocacy group BIO (Biotechnology Innovation Organization) and signed by over 200 CEOs, founders, investors, and scientists, warns that overturning the FDA’s approval of mifepristone—or limiting its availability—would set a dangerous precedent. They argue that such actions would undermine trust in the agency’s regulatory processes and introduce unnecessary political interference into science-based decisions.
A Call to Defend Scientific Integrity
“We are deeply concerned about the potential consequences of allowing courts or political actors to override the FDA’s authority on the basis of ideology rather than science,” the letter states. “Such actions could jeopardize the stability of the entire drug approval process and threaten innovation across the biopharmaceutical sector.”
Among the signatories are prominent figures from biotech startups, venture capital firms, and pharmaceutical companies who argue that regulatory clarity and independence are essential for the continued growth of the sector. The industry relies heavily on the FDA’s rigorous scientific review to evaluate new therapies, guide investment decisions, and ensure patient safety. Undermining that process, they say, could deter future innovation and chill investor confidence.
The letter comes at a pivotal moment for the FDA and for reproductive healthcare policy in the U.S. After the Supreme Court overturned Roe v. Wade in 2022, several states moved swiftly to ban or severely restrict abortion. Legal battles have since spread to mifepristone, even though it remains FDA-approved and widely regarded as a critical component of reproductive health.
Legal and Regulatory Ramifications
In one high-profile lawsuit, a coalition of anti-abortion groups challenged the FDA’s approval of mifepristone, seeking to remove it from the market entirely. The case was heard by the U.S. Supreme Court in 2024, and while the Court ultimately ruled on procedural grounds that the plaintiffs lacked standing, the litigation highlighted the growing legal pressure on the agency and the pharmaceutical companies it regulates.
Biotech leaders fear that if the approval of mifepristone can be revoked or restricted without scientific justification, other essential medicines could be next. “If political pressure or judicial activism can undo drug approvals that are based on decades of data, no product is safe,” said one biotech CEO who signed the letter. “This isn’t just about mifepristone—it’s about protecting the integrity of the entire drug development ecosystem.”
The Business of Science
In addition to the scientific arguments, the letter also emphasizes the potential economic fallout. The U.S. biotech and pharmaceutical industry contributes hundreds of billions of dollars to the economy annually and supports millions of jobs. Regulatory instability could have far-reaching effects on startup formation, clinical trial investment, and international competitiveness.
Many investors view the FDA’s independence as a key reason to fund U.S.-based drug development. “If investors cannot rely on the FDA’s decisions to stand, capital will flow elsewhere,” the letter notes.
A Broader Industry Push
This initiative follows similar calls from the scientific and medical communities urging the government to protect evidence-based policymaking. Organizations such as the American Medical Association, American College of Obstetricians and Gynecologists, and numerous public health groups have also defended mifepristone’s safety profile and its critical role in women’s health.
For the biotech industry, the stakes are particularly high. The letter ends with a direct appeal to the FDA and policymakers to resist efforts that politicize science and erode confidence in the regulatory system.
