NY.- Senior executives from more than 400 pharmaceutical and biotech companies and investors on Monday issued an emphatic condemnation of a federal judge’s decision that invalidated the Food and Drug Administration’s (FDA) approval from 23 years ago. years, of the abortion pill Mifepristone, and called for that decision to be reversed.
“The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders of some of the industry’s most prominent companies, including Albert Bourla, Pfizer’s chief executive, and Alisha Alaimo, president of Pfizer. Biogen.
The decision, issued by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, “has set a precedent for diminishing the FDA’s authority over drug approvals, and in doing so creates uncertainty throughout the industry. biopharmaceutical,” argues the letter.
On Monday afternoon, the Justice Department, which represents the FDA, filed a motion asking the United States Court of Appeals for the Fifth Circuit to uphold the Texas ruling until the Department’s appeal of the case can be heard. listened.
Judge Kacsmaryk has upheld his ruling for seven days only.
The executives’ letter notes that their companies rely on the autonomy of the FDA to place products on the market according to “a credible regulatory process for drug evaluation and approval.”
“If courts can strike down drug approvals without regard to science or evidence or the complexity that full approval and efficacy of new drugs require, any drug is at risk of having the same outcome as has been the case with Mifepristone.”
The letter underscores how threatening the ruling would be, if upheld, to pharmaceutical companies, said William B. Schultz, a former FDA deputy commissioner who now practices private law.
Schultz said that companies spend years and hundreds of millions of dollars to test and study a drug.
“I think that could destabilize pharmaceutical research in this country,” he added.
