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PDUFA Extension Adds More than Funding

The expiring Prescription Drug User Fee Act (PDUFA) has been reauthorized and expanded. For the first time, the bill provides a mechanism for risk management planning. The new PDUFA also requires FDA to turn to independent consultants to help resolve disputes over Phase III trial design. At a time when managerial issues at the FDA seem to have raised the level of uncertainty, the new PDUFA rules could prove a welcome measure of predictability.

Following eight-and-a-half months of negotiations between Congress and the trade associations PhRMA and BIO, the expiring Prescription Drug User Fee Act (PDUFA), under which companies pay FDA to help support and speed up new drug approvals, has been reauthorized and expanded. For the first time, the bill provides a mechanism for risk management planning. The new PDUFA also requires FDA to turn to independent consultants to help resolve disputes over Phase III trial design.

The legislation was attached to the bioterrorism bill signed by President Bush, which calls for $1 billion in additional funding...

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