House lawmakers set an ambitious deadline Thursday for reauthorizing a program that helps fund the Food and Drug Administration's drug review process, hoping that an early start and a history of bipartisan compromise will speed legislation through a divided Congress. House Energy and Commerce Subcommittee on Health Chairman Joseph Pitts, R-Pa., said at the first hearing on reauthorization that he wanted a measure signed into law by June 30, 2012 - three months before the current authorization expires.

The law, created in 1992 (PL 102-571), authorizes the FDA to collect user fees from the industry to help pay for drug reviews. Currently, the agency is negotiating a reauthorization deal with drug and biotechnology companies, which would then be approved by administration groups including the Office of Management and Budget. After that, Congress would begin considering a bill.

Lawmakers took a broad view at the hearing on what would be the fifth reauthorization. They focused on industry concerns that an uncertain regulatory environment at the FDA is leading to a drop in pharmaceutical investments, as well as prompting companies to move to different companies. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, defended the agency's system, noting that the drug approval process in the United States is faster than in Eurpor. She said the agency has been working with the industry to address regulatory problems that impede innovation and development of new medicines. But she acknowledged a "severe productivity problem worldwide," with increasing investments in research and development leading to fewer new drugs getting produced. "It is no exaggeration to say that the industry is in crisis," said Woodcock.

Jonathan Leff, managing director at the investment firm Warburg Pincus, said the changing regulatory environment at the FDA has led to declining investments in the U.S. pharmaceutical industry, hampering innovation. "The cost, time, and risk in developing new drugs and biologics have increased to unsustainable levels," said Leff. "As a result, vital risk capital is being diverted to other industries and other countries." Woodcock countered that the problem lies with scientific challenges in new drug development, not the FDA's regulatory process. "It's hard to lay this at FDA's feet," she said.

Several lawmakers, including Michael C. Burgees, R-Texas, called for changing the law's provision regarding conflicts of interest for people serving on agency advisory committees. Currently, 13 percent of the experts who sit on FDA's advisory panels are allowed to get waivers that let them review a case even if a committee member has conducted research with grants from a drug company whose product is under review, among other potential conflicts. Burgess said that the Institute of Medicine has recommended that 40 percent of panel members be allowed to get a waiver. But Burgess did not specify what waiver percentage he would push for in the next reauthorization. Burgess said the current conflict of interest rules prevent the FDA from using experts who may be the most qualified to serve on a committee.

Marc Boutin, executive vice president and CEO of the National Health Council, said about 25 percent of the FDA's advisory committees are currently vacant. "We have to balance the need for transparency and managing of conflicts of interest with the need to ensure that we get treatments to people who need them," said Boutin. Woodcock acknowledged that the agency has had trouble recruiting qualified people to serve on the advisory panels and has had to postpone committees in some cases.

Witnesses also discussed the agency's lack of ability to thoroughly oversee and inspect imported pharmaceutical products and raw materials. John D. Dingell, D-Mich., said the 2008 drug scare involving the contaminated blood-thinning drug heparin from China showed the agency does not have sufficient resources or the authority to ensure the safety of imported products. "Imports of dangerous components and materials, as in the case of heparin, continue to threaten our people," said Dingell.

Woodcock said that a bill (HR 1483) introduced by Dingell would give the agency the authority it needs to address incidents similar to the heparin problem. The agency is redirecting domestic inspection resources to do more overseas inspections, Woodcock added, noting that agency inspectors visit foreign manufacturers an average of once every nine years.