Twelve former Food and Drug Administration commissioners on Dec. 3 said they oppose the agency’s new position on vaccines, as outlined in a recent memorandum.
“The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity,” Dr. Robert Califf, the last FDA commissioner during the Biden administration, and 11 other ex-commissioners wrote in a opinion piece published by The New England Journal of Medicine.
“If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes; it would also suppress innovation and competition. The net effect would be to disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”…