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The reauthorization of the Prescription Drug User Fee Act (PDUFA) comes but once every five years. Set to expire September
30—and with congressional Democrats riding high and consumer confidence in drug safety at record lows—the deal by which pharma
pays FDA to review its products is in for a long hot summer of debate. • The line of merry pols and other souls, including
industry lobbyists, patient advocates, and FDA bigwigs past and present, who are hanging their wish lists on this post-Vioxx
PDUFA is already mighty long. By the time the bill finally rolls out for a vote, it's bound to be as big as a Rockefeller
Center Christmas tree. • On April 18, the Senate Committee on Health, Education, Labor, and Pensions (HELP) made some headway
by passing "Kenzi"—a bill from Ted Kennedy and Mike Enzi that sharpens the agency's teeth when it comes to monitoring drug
safety, while shaking down pharma for 45 percent higher user fees. • Kenzi is widely viewed as the best-bet compromise between,
on the one hand, PDUFA IV, the FDA–pharma proposal that merely tweaks the status quo, and, on the other, sweeping agency makeovers,
including a competing Senate bill from Chris Dodd and Charles Grassley that calls for a brand-new safety center. Oh, and there's
a growing chorus singing a "Kill PDUFA" carol. • We thought we'd play Santa's helper and provide a guide to the most eye-catching
balls—er, bills.
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