Ever since 1992, when US lawmakers passed the Prescription Drug User Fee Act (PDUFA) to accelerate review of new drugs by the US Food and Drug Administration, industry money has had an increasingly important role in fueling the regulatory agency. In the program’s first year, drug companies paid less than $9 million total to the FDA through the initiative. But in the past two decades the amount has ballooned; this year, the agency anticipates receiving at least $619 million in user fees, composing roughly 65% of its budget for overseeing human drugs.

Despite the torrent of funds, the FDA has still failed to meet its goal of completing the review of 90% of new drug applications within ten months. Industry isn’t exactly pleased with this report card, and they have spent the past year in negotiations with the agency to plan how the fees can be used to make drug review more efficient.

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