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Trump's proposed budget doubles FDA regulatory fees

Published on 16/03/17 at 09:39am

Trump’s presidency could cost the industry more than twice as much in regulatory review fees next year, as his administration doubles the proposed budget for FDA collections in 2018 to over $2 billion.

The budget, released this week, justifies the steep hike as necessary in a climate where funding and budgets are tight. The FDA itself is known to be struggling with understaffing, with the organisation reportedly scrambling to fill around 700 vacant roles at the end of last year. In this environment, the budget argues that those companies seeking the FDA’s approval for their products “can and should pay for their share”.

The proposed budget also echoes Trump’s consistent statements that it will help accelerate approval of new drugs, but did not specify how this would be achieved. Criticisms have been commonly levied against the FDA’s failure to maintain swift approval timelines, and the organisation has felt pressure to meet difficult deadlines alongside staffing woes.

In 2017, the FDA is expected to collect around $866 million for prescription drugs and $324 million from generics. It has been charging companies since 1992.

Matt Fellows

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