FDA's user fee program awaits renewal for next 5 years

Reauthorizing the FDA's user fee program, which allows the agency to decide how much to charge pharmaceutical and medical device-maker companies for their product submissions,  was added to a spending bill Sept. 22 to prevent a government shutdown, according to The Hill.

The federal government must decide whether to reauthorize the FDA's user fee program every five years. Last year, the FDA collected $1 billion from reviewing new drug and device applications. Its current authorization is set to expire unless it gets renewed by the end of September.  

Critics of the program and the five-year swivel have said it's a "devil's bargain."

"It turns this every-five-year cycle into the FDA essentially asking industry, 'What can we do to secure this money?'" Joseph Ross, MD, New Haven, Conn.-based Yale School of Medicine professor who studied FDA policies, recently The New York Times.

Robert Califf, MD, the FDA Commissioner, told employees in a July letter that "user fees are critical to the work of the FDA, ensuring that we have the resources needed to protect public health and accelerate innovation."

Congress has until Oct. 1 to pass the fiscal bill to avoid a government shutdown, according to The Hill.

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