'I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don't put profits over patients,' says repmaloney
"This report documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm."
The panel also found that Biogen and the FDA closely collaborated on a document written for outside advisers during the approval process, with at least one paragraph of the company's submission authored by agency officials. "This report documents the atypical FDA review process and corporate greed that preceded FDA's controversial decision to grant accelerated approval to Aduhelm," outgoing House Energy and Commerce Committee Chair Frank Pallone said in a;“NEW: Chairman @FrankPallone and House Oversight Chair @RepMaloney release report on the controversial review, approval, and pricing of Biogen;’s Alzheimer;’s drug Aduhelm.
"I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don't put profits over patients," she added.
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