New Congress, New Challenges in the Year Ahead

Reauthorization of PDUFA will focus attention on drug safety, product pricing, and a host of regulatory issues.
Jan 02, 2007
Volume 31, Issue 1

Jill Wechsler
Democrats are back on top in Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to needed treatments are high on the priority list. Manufacturers will be in the hot seat answering questions about patent practices, high-risk products, and why drugs cost less in other countries than in the United States. The real challenge, however, will be to gain approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on Sept. 30, 2007. Such legislation also would renew user fees for medical devices and continue the pediatric drug exclusivity program.

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.

In Washington This Month
The more narrowly divided Senate will adopt a more collaborative approach, making it easier for industry to gain a hearing on PDUFA and other important issues. Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Sen. Ted Kennedy (D-MA) has cosponsored drug-safety legislation with ranking minority member Mike Enzi (R-WY), and the two plan to work together on PDUFA reauthorization and related measures.

FDA officials and industry representatives have been discussing user-fee issues and options for several months to present an agreed-on user-fee plan to Congress to shape the debate. The PDUFA proposal includes requested fees, timelines for application processing, and the range of FDA activities that fees will support. The new five-year agreement is expected to boost user fees considerably to generate about $400 million in payments, with the cost of filing a new drug application (NDA) jumping over the $1-million mark. Added fees have been proposed to support more timely review of manufacturer advertising and marketing materials, as well as a significant expansion in FDA postmarketing safety oversight. But efforts by Congress to tap fees to fund additional FDA activities tangential to application review will set off a sharp debate over just how much of government activities should be supported by industry fees.

Adding on

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.

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