White House Slams Generic Exclusivity Provisions In User Fee Bill
Trump administration says generic exclusivity provisions – which have been softened from the original bill – are unpredictable and could decrease competition; and while the White House is displeased with exclusivity, and wants higher user fees, it is not explicitly threatening a veto.
You may also be interested in...
Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.
Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.
President wants substantially more user fee revenue than negotiated in user fee agreements, and some in industry already are warning that requiring increases now could endanger program reauthorizations.