An open letter signed by more than 50 industry executives blasts a “fundamentally, fatally flawed” report that urges greater restrictions on the abortion pill.
A group of 53 biotech executives and life sciences investors is asking the FDA to refrain from taking actions that would impede patients’ access to the abortion drug mifepristone, urging the agency to follow its tradition of “rigorous scientific evaluations” in making policy calls.
The request, made in an open letter on Monday, follows an April report from the anti-abortion advocacy group Ethics and Public Policy Center, which alleges that more than 10% of women who have taken mifepristone suffered from serious adverse events, such as hemorrhages and sepsis. In response to the report, Health Secretary Robert F. Kennedy Jr. in May ordered the FDA to review its regulations around mifepristone.
The biotech experts on Monday criticized this report, calling it “fundamentally, fatally flawed.” They pointed to several “methodological flaws that make any conclusion unreliable,” including the conflation of emergency room visits with the occurrence of serious adverse events. Such a move, they argued, not only contradicts the FDA’s own guidance but can exaggerate the frequency of complications associated with mifepristone.
Signatories to the open letter include Arcutis CEO Frank Watanabe and Nkarta CEO Paul Hastings, alongside Peter Kolchinsky, managing partner at RA Capital Management and Nina Kjellson, venture capital investor.
The report also lacks transparency, according to the letter. “It was self-published and not peer-reviewed. It was not reviewed in the standard scientific vetting process. To date, the data set has not been made available to researchers in the field.”
In contrast, the evidence supporting not just the efficacy but also the safety of mifepristone is “overwhelming,” the experts said.
The FDA should not base regulatory and policy decisions on such a flawed report, according to the open letter, which argued that “doing so would pave the way for any political or interest group to undermine well-grounded FDA decisions with baseless claims.”
Abortion—and mifepristone by extension—has long been a political flashpoint in the U.S. In November 2022, the Alliance for Hippocratic Medicine sued the FDA, seeking to push the agency into withdrawing approval for the drug. In the legal complaint, the conservative group alleged that in approving mifepristone, the regulator made a politically-motivated decision, rather than a scientifically-driven one.
A few months later, in April 2023, Texas Judge Matthew Kacsmaryk blocked sales of mifepristone through a preliminary injunction—a move that sparked a legal back-and-forth that made it all the way to the Supreme Court. The high court in June 2024 ultimately ruled in favor of the FDA, preserving widespread access to the drug.
