Some 300 biotech executives and industry leaders are objecting to the decision from a Texas federal judge to block the FDA’s approval of abortion drug mifepristone. The executives argue that the judicial interference will undermine the agency’s authority and endanger innovation in the industry.
“Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” the biotech executives wrote in an open letter that has collected 299 signatures as of publication.
The ruling came on Friday from U.S. District Judge Matthew Kacsmaryk. Mifepristone has been cleared for use for almost 23 years and has been proven safe and effective. It’s the primary medicine used to induce a medical abortion in the U.S.
Hours after Kacsmaryk’s ruling, a second ruling in Washington from U.S. District Judge Thomas Rice ordered the FDA to preserve the medicine’s status in 17 states and Washington, D.C.—creating uncertainty across the country.
By Monday, the White House and Department of Health and Human Services (HHS) had vowed to fight Kacsmaryk’s ruling, while House Democrats introduced legislation to protect the FDA’s authority as the agency in charge of approving drugs. The Department of Justice filed an appeal in the Texas case, while HHS Secretary Xavier Becerra called the ruling “regressive” and said it “opens the door for courts to overturn FDA’s evidence-based decisions for purely political or ideological reasons.”
The biotech industry letter was signed by leaders from Bayer, Ovid Therapeutics, Daré Bioscience, Atlas Ventures, CRISPR Therapeutics, 89bio, Tyra Biosciences, Absci, Vedanta Biosciences and many more. Nkarta CEO Paul Hastings—serves as chair of the Biotechnology Innovation Organization—signed his name, as did ReCode Therapeutics CEO Shehnaaz Suliman, M.D., who spearheaded a similar letter when Roe v. Wade was overturned last year. Another prominent name was Robert Langer, the MIT professor whose work has spawned a handful of biotechs—including Moderna.
And on Monday morning, Pfizer CEO Albert Bourla added his name and Big Pharma weight to the list.
“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” the biotech leaders wrote.
If judges can unilaterally rule to overturn drug approvals without any regard for science or evidence, the biotech leaders say that “any medicine is at risk.”
“While the drug development, approval and monitoring process is not perfect, the agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile,” the letter says.
The leaders called for the decision to be reversed and for FDA’s authority to be restored. “In the face of laws and rulings that aim to undermine the evidence-based and legislatively sanctioned authority of federally mandated institutions such as FDA to protect public interests and by putting an entire industry focused on medical innovation at risk, we cannot stay quiet,” the letter concludes.