More than 400 pharmaceutical and biotech executives on Monday called for a reversal of a US judge’s decision to halt the sale of an abortion pill, fearing it could pave the way for the discount due to other medications.
“A federal judge with no scientific training has fundamentally undermined the authority granted by Congress to the American Medicines Agency (FDA)”, denounces a letter signed in particular by the boss of Pfizer, Albert Bourla, and representatives of other large laboratories like Biogen, AbbVie or Novartis.
His decision “ignores decades of scientific evidence and case law”, say the signatories.
Above all, by questioning the legitimacy of the FDA to authorize drugs, it “creates uncertainty for the entire biopharmaceutical sector”.
“If courts can overturn drug approvals without regard to science or evidence, or the complexity required to fully verify the safety and efficacy of new drugs, any drug risks meeting the same fate” as the pill abortifacient, is it underlined in the letter. This could lead to drug approval in some states and not others, and stifle innovation, its authors fear.
Known for his ultra-conservative views, Magistrate Matthew Kacsmaryk on Friday withdrew marketing authorization for mifepristone, an abortion pill approved for more than 20 years, resuming studies on the risks attributed to the drug and accusing the FDA of not failed to comply with its procedures in order to meet a political objective.
But “it has been proven by decades of data that (mifepristone) is safer than (paracetamol), almost all antibiotics and insulin,” the letter notes.
“While the drug development, approval and monitoring process is not perfect, the Agency’s framework has enabled decades of unparalleled medical innovation and statutory mechanisms to remove drugs from the market if, between others, they do not maintain the expected safety and efficacy profile”, it is also noted.
The letter was notably initiated by Amanda Banks, co-founder of Blackfynn, Jeremy Levin, boss of Ovid Therapeutics, Paul Hastings, boss of NKarta Therapeutics, Shehnaaz Suliman, boss of ReCode Therapeutics and John Maraganore, founder of Alnylam Pharmaceuticals, specified to the ‘AFP a spokeswoman for ReCode Therapeutics.
This spokeswoman and Amanda Banks told AFP that more than 400 officials had signed the missive.