The decision, according to more than 400 executives, disregarded both scientific and legal precedence and, if it were to stand, would cast the pharmaceutical and biotech industries into turmoil.
Senior executives from more than 400 pharmaceutical, biotech, and investment firms harshly denounced a federal judge's decision to invalidate the Food and Drug Administration's (FDA) 23-year-old approval of the abortion drug mifepristone and demanded that the ruling be overturned on Monday.
The letter, which was signed by executives from some of the most well-known firms in the sector, including Albert Bourla, chief executive of Pfizer, and Alisha Alaimo, president of Biogen, warned that the decision "ignores decades of scientific evidence and legal precedent."
The letter claims that Judge Matthew J. Kacsmaryk's decision "has set a precedent for diminishing F.D.A.'s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry."
The Federal Drug Administration is being represented by the Department of Justice, which on Monday filed a motion asking the U.S. Court of Appeals for the Fifth Circuit to stay the Texas verdict until the outcome of the department's appeal of the matter. Only a week has passed since Judge Kacsmaryk's decision was postponed.
According to the executives' letter, their businesses depend on the FDA's independence to develop goods and submit them to a "reliable regulatory process for drug evaluation and approval."
"Any medicine is at risk for the same outcome as mifepristone," the letter said. "If courts can overturn drug approvals without regard for science or evidence or for the complexity required to fully vet the safety and efficacy of new drugs."
The letter emphasises how dangerous the decision could be to pharmaceutical corporations if it is upheld, according to William B. Schultz, a former F.D.A. deputy commissioner and current attorney in private practise. Companies test and study a medicine for years and hundreds of millions of dollars, according to Mr. Schultz.
I believe it could undermine pharmaceutical development in this nation, the man stated.
Legal experts stated in interviews that the decision looked to be the first occasion a court attempted to invalidate the F.D.A.'s approval of a medicine. Congress has granted the agency the power to judge whether pharmaceuticals are both safe and effective over many years.
According to Jennifer Oliva, a law professor at U.C. College of the Law, San Francisco, the Texas verdict has the potential to invalidate the approval of so many medications that the letter is likely only the start of a vigorous push by the pharmaceutical industry.
They will exert significant pressure on state legislatures, Congress, and the courts in the ongoing legal battles because it jeopardises their livelihood, according to Ms. Oliva.
A trade association for biotech businesses called BIO, whose interim president and chief executive is Rachel King, said her group has not signed the letter but is determining the best method to support the F.D.A.'s power with its board.
In a statement over the weekend, the group referred to the decision as "an assault on science."
It would increase uncertainty in drug research and approval, which will ultimately be detrimental to patients, according to Ms. King.
The first tablet in the two-drug abortion treatment regimen is mifepristone. The second medicine, misoprostol, which is licenced for various medical ailments but taken off-label for abortion, is also a target of the plaintiffs in the Texas action. A minor portion of the misoprostol distributed in the US is produced by Pfizer.
Pfizer did not support the use of any of its medications outside of their approved indications, according to a spokeswoman on Sunday, but the agency "serves a critical role in the U.S. public health system — bringing new medicines to patients and conducting ongoing safety reviews that support the continued use of them — that must be maintained."
