PDUFA countdown

When FDA officials and representatives of the pharmaceutical and biotech industries meet in January to begin serious negotiations on reauthorizing the Prescription Drug User Fee Act, they will have relatively modest goals compared to the giant agenda hammered out in 1997, when FDA reform also was on the table.

FDA's primary focus will be stabilizing the rickety financial superstructure that the last PDUFA deal created, primarily by extracting commitments from industry for larger payments and obtaining greater flexibility in how the funds are spent.

Pharmaceutical companies want as little change in the status quo as possible.

And the biotech industry hasn't yet developed detailed goals, although its overriding concern will be reversing a recent trend toward increased approval times.

At the same time, each side of the triangle has incentives to mend PDUFA and to resist efforts from consumer and patient advocacy groups to abolish or fundamentally restructure the user fee relationship.

The current user fee configuration is based on two sets of negotiations: the original PDUFA I, which was in effect from 1992 to 1997, and PDUFA II, which started in 1998 and expires Sept. 30, 2002. In both instances, FDA and industry negotiated agreements and presented them to Congress, which enacted them into law.

Under PDUFA I, industry provided the agency with funds to hire 660 additional reviewers in exchange for commitments to meet performance goals,

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