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Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

Staffing Cuts At FDA Could Threaten Ability To Collect Biosimilar User Fees

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

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Key Takeaways
  • The biosimilar user fee program may be at most risk of missing its non-user fee spending trigger this fiscal year due to layoffs and other personnel departures.
  • If the trigger is not met, the FDA would have to return money that theoretically already has been spent, which could be a violation of federal law.
  • The BsUFA program flirted with missing its spending trigger three of the last six fiscal years.

Recent US Food and Drug Administration layoffs may have put the biosimilar user fee program at high risk of violating spending rules, which could force staff to return funds to...

An FDA official, who soon will depart as part of the reduction-in-force, told the Pink Sheet that the agency may not be able to spend the necessary amount of non-user...

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