Box 1. PDUFA update

First passed in 1992, PDUFA provides the FDA with almost half of its drug review budget—$86 million in 2005. The bill expires in October 2007, and in November 2006 the pharmaceutical and biotech industries concluded year-long negotiations with FDA over a new fee structure.

"We've agreed to significantly higher fees and we expect to get quicker turnaround in approval of applications," says BIO's Greenwood. The higher fees could also be used to fund postmarket surveillance and more robust review of direct-to-consumer advertising. A high-ranking biotech executive notes that the new fee structure would push the proportion of industry funding for FDA drug review to "north of 60%."

Sheila Burke, cochair of a Washington, DC–based IOM committee that issued a report in September 2006 highly critical of the FDA's drug approval and safety process, says that increasing the agency's dependency on user fees "may hurt its credibility." The IOM report recommends Congress replace user fees with additional appropriations, but that seems unlikely.

Congress must ratify the final fee structure, and could roll elements of proposed FDA safety overhauls into a PDUFA reauthorization package.

Amit Sachdev, executive vice president for health at BIO, is concerned such legislation would be "inconsistent" with the PDUFA negotiations. "We support the notion that there needs to be robust postmarket surveillance....We think that it's important to have a much better process for establishing appropriate phase 4 study commitments....We're cognizant that compliance is not always high," he adds. He says that rectifying the competing PDUFA and safety bill proposals "will be a real discussion."