Woodcock: FDA may have misstepped before Alzheimer’s drug approval
WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling of its polarizing approval of a new Alzheimer’s drug.
She was emphatic in her defense of the therapy and the agency’s approval decision in an interview at STAT’s Breakthrough Science Summit, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved.”
“Was the process done exactly the best that it could be?” she said. “Possibly not.”
WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling of its polarizing approval of a new Alzheimer’s drug.
She was emphatic in her defense of the therapy and the agency’s approval decision in an interview at STAT’s Breakthrough Science Summit, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved.”
“Was the process done exactly the best that it could be?” she said. “Possibly not.”