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White House Slams Generic Exclusivity Provisions In User Fee Bill

 
• By Michael Cipriano

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.

Capitol House

White House displease with the basic structure of the user fee legislation is nothing new (the administration wants industry to basically fund all review activities and congressional leaders says it's too late to renegotiate) but the White House's statement of policy on the "pre-conferenced" bill could complicate passage of the legislation, which already appeared to have some emerging hurdles in the Senate.

In a July 13 statement House's passage of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the White...

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