GPhA’s Next CEO Will Face Political, Regulatory Headwinds
Ralph Neas will leave the generics association in the fall after a successor is found, as user fee and exclusivity reforms await.
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David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person to run the association since February 2020.
Chip Davis still believes in innovation, but now must balance that with affordability in new role leading the generic association.
The reauthorization of the Generic Drug User Fee Act isn’t going to be as straightforward as the PDUFA process has been for the past two decades. Instead, expect a replay of the first medical device fee renegotiation – with plenty of threats from industry to walk away from the program altogether, likely intended to end up with the best possible deal.