The total base fees for prescription drugs to be collected for fiscal year 2018 under the legislation would be about $878.8 million, up 22% from the current fiscal year’s amount of $718.7 million, according to congressional aides.
The payments from industry have previously accounted for 70% of the FDA’s brand-name drug review budget, 36% of the medical device review budget, 75% of the budget for generic drug reviews and 29% of that for biosimilars, which mimic complex biological drugs.
Industry fees for medical products total about $1.3 billion in the current FDA budget of about $4.8 billion.
So far, the draft bill made public by the leadership of both parties has been relatively lacking in controversy, but that could change.
The dollar amounts in the bill were negotiated by the FDA with the industries involved.
However, the issue got more complicated last month when the Trump administration said it planned to nearly double, to more than $2 billion, the user fees collected from the medical industry.
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