US FDA Exploring Furlough Possibility If User Fee Bill Not Enacted In Time
Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.
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After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.