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Back Page: Christmas in July

'Tis the season to renew PDUFA, and the tree-hanging party is in full swing

May 1, 2007
By: Walter Armstrong
Pharmaceutical Executive

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.