FDA Gives Congress Reprieve On Deadline For Passing User Fee Bill
Commissioner Gottlieb says agency won't issue layoff notices 'unless and until Sept. 30 passes without reauthorization.'
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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.
User Fee Bill Or Drug Pricing Bill? House Members Makes Both Cases
House passes bill reauthorizing FDA user fee programs via voice vote and makes many other policy changes, but in the process touts the bill's potential to push drug prices lower.
Gottlieb Distances Himself From Trump's User-Fee Heavy Budget
New FDA commissioner passes on defending president's budget proposal during House appropriations subcommittee hearing. With Congress disinclined to reopen user fee negotiations, Gottlieb instead focuses on his priorities for agency.