Over 400 pharmaceutical employees and executives signed an open letter in a show of solidarity with the FDA, but some say that big pharma’s actions helped lead to this moment in the first place.
More than 400 pharmaceutical executives and corporations have signed an open letter1 condemning Texas-based District Judge Matthew Kacsmaryk’s ruling to overturn the FDA’s 23-year-old approval of abortion pill mifepristone. In response to the unprecedented ruling from Kacsmaryk, pharmaceuetical executives from companies including Pfizer, Biogen, Merck, ReCode Therapeutics, Blackfynn, and Ovid Therapeutics signed a letter in support of the FDA’s regulatory process. As of publication of this article, executives from Moderna, Eli Lilly, and Johnson & Johnson had not signed the letter.
Overall, the letter calls into question the validity and legality of Kacsmaryk’s decision, in which he sided with anti-abortion groups over controversial claims regarding mifepristone’s safety.
“The decision ignores decades of scientific evidence and legal precedent. 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 letter said in part.
The letter goes on to say that those signing it “cannot stay quiet” and that a ruling such as Kacsmaryk’s would undermine a process that is “evidence-based” and “legislatively sanctioned.”
A lawyer for the plaintiffs—a collection of anti-abortion advocates—said in a statement2 that “Chemical abortion drugs don’t provide a therapeutic benefit—they can cause serious and life-threatening complications to the mother, in addition to ending a baby’s life,” though there is overwhelming evidence that mifepristone is safe to use and effective in its purpose of medically ending a pregnancy. The lawyer went on to add that the FDA “must be held accountable for its reckless actions.”
The open letter was met with some scrutiny of its own. In a piece for The American Prospect3, David Dayen wrote, “The industry’s lament about judicial activism feels a bit like Dr Frankenstein expressing outrage over the destruction carried out by his monster. The pharmaceutical industry as a whole, and many of the individual officials who signed the letter, financially supported the Senate Republicans who confirmed Kacsmaryk to the federal bench.”
The numbers back up Dayen’s claims, too. According to data published in late 2021 by Pharma Cash to Congress via Kaiser Health News4, “Pharmaceutical companies and their lobbying groups gave roughly $1.6 million to lawmakers,” in the early half of 2021, “with Republicans accepting $785,000 and Democrats $776,200.” So while a show of solidarity with the FDA is nice, Dayen argues, many of the companies that signed the open letter created the circumstances that allowed an event like Kacsmaryk’s ruling to transpire in the first place.
News recently broke that Mifepristone will remain available—albeit with heavier restrictions than before. It will be interesting to watch how big pharma companies respond to this news and move forward with their support of the FDA.