Reaching agreement on these must-pass measures in a short time frame will require industry to negotiate with some highly critical Congressional leaders. Reps. John Dingell of Michigan and Henry Waxman of California, both key players in shaping the original user fee program 15 years ago, will be orchestrating the debate. Dingell now chairs the House Energy and Commerce Committee, which oversees the US Food and Drug Administration and multiple healthcare issues. Waxman is the senior Democrat on that panel and also will be investigating industry practices and FDA programs as chairman of the House Government Reform Committee.
With Democrats and Republicans unlikely to agree on many legislative proposals this year, both sides will regard any PDUFA bill as a ready vehicle for confronting a broad range of healthcare issues. Measures to enhance drug safety, to speed generic drugs to market, and to expand drug importing are all likely to be hung on the PDUFA Christmas tree. There may even be a move to give FDA authority to regulate tobacco, an issue that has gained broad support on Capitol Hill.
"All these issues will be in play," acknowledges Jim Greenwood, president of the Biotechnology Industry Organization (BIO) and formerly a leading Republican on the House Energy and Commerce Committee. Industry's task is to identify a working majority in the House and Senate that can "deal with these issues responsibly," Greenwood says. With PDUFA, "we can't play veto games."
Focus on safety
A top priority for Congress is to enact drug-safety legislation. Kennedy and Enzi have developed a bipartisan measure that retains FDA's current oversight structure instead of establishing an independent drug-safety office. The legislation backs most other popular proposals: stronger controls on the use of high-risk therapies, a more powerful drug-safety oversight board to resolve disputes, curbs on drug advertising, broader posting of clinical trial results, and penalties for failure to complete postapproval studies. Enzi and Kennedy held a hearing on the proposal in November 2006 to jump-start deliberations on this high-profile issue.