The Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone was invalidated in a ruling by Judge Matthew J. Kacsmaryk on Monday. As a result of which senior executives of pharmaceutical and biotech companies have expressed their strong disagreement. They issued a letter condemning the ruling and calling for it to be overturned, leading the pharmaceutical industry into a legal battle over the drug.
Over 400 leaders of major investment firms and drug and biotech companies, none of which produce mifepristone, signed a statement expressing concern that the recent FDA ruling invalidating the drug’s approval could have far-reaching implications beyond just abortion.
Scientific evidences disregarded
They argue that if courts can overturn drug approvals without scientific evidence or due process, the entire regulatory system for medicines in the United States could be threatened. The statement was made on Monday, the same day that the Justice Department requested that the U.S. Court of Appeals for the Fifth Circuit delay Judge Kacsmaryk’s ruling until the department’s appeal could be heard.
The Justice Department has filed a motion to delay the recent ruling invalidating the FDA’s approval of mifepristone, stating that it would go against the FDA’s scientific judgment and have severe consequences for women who rely on the drug for medical or practical reasons.
The motion also noted that mifepristone is used in treating miscarriages and has lawful uses in every state, and that the court’s order would harm healthcare systems and the interests of medical providers and businesses. The plaintiffs, a coalition of anti-abortion groups and doctors, have until midnight Tuesday to respond.
The pharmaceutical and biotech executives who signed the letter were similarly concerned about the potential destabilizing effects of the Texas ruling on the regulatory system for all medicines in the US.
FDA’s authority undermined
According to Dr. Jeremy Levin, CEO of Ovid Therapeutics and former chairman of BIO, he and several other industry leaders have been concerned about the Texas lawsuit regrding the abortion pill since it was first filed in November. Levin said Judge Kacsmaryk’s ruling completely undermines the FDA’s authority and allows political determinations to be made about medicines, which could be harmful to vaccines, Alzheimer’s drugs, and others.
Dr. Shehnaaz Suliman, CEO of ReCode Therapeutics, and Dr. Amanda Banks, former CEO of Blackfynn Therapeutics, started drafting the letter a few weeks ago, after a March 15 hearing in Judge Kacsmaryk’s courtroom in Amarillo, Texas. Dr. Suliman stated that the main concern of the letter is the court’s overreach and its possible application to other diseases or products regulated by the FDA.
Call to action
Dr. Suliman was also involved in organising a “call to action” among members of the industry in response to the Supreme Legal experts noted that the Texas ruling could have significant implications as it could be the first time that a court has attempted to overturn the approval of a drug against the F.D.A.’s objections.
The F.D.A. has had the power to determine the safety and effectiveness of drugs for many years. According to Jennifer Oliva, a law professor at the University of California, San Francisco, who supported the F.D.A. in a brief filed with Judge Kacsmaryk’s court, the pharmaceutical industry is likely to take further action to oppose the ruling since it could have far-reaching consequences. This could involve lobbying state legislatures and Congress and getting involved in court battles, as it could threaten their businesses.
