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FDA device chief: More review funding needed

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration needs more funding to help discourage staff turnover and help speed reviews, the agency's device chief said on Thursday.

FDA reviewers are stretched thin with a heavy workload and increasingly complex technologies to evaluate, Dr. Jeffrey Shuren told lawmakers at a hearing on device regulation's impact on jobs and patients.

"We need to find means to handle an ever increasing workload and reduce staff and manager turnover," Shuren told lawmakers on a House Energy and Commerce subcommittee.

Budget cuts proposed by House of Representatives Republicans would cause "increased delays" and "deny patients truly safe and effective innovative technologies," he said.

Shuren told reporters the FDA needed more funding from taxpayers or higher fees paid by companies seeking approval for their products. Device makers, which include Medtronic Inc, Johnson & Johnson and Boston Scientific, and the FDA are negotiating new fees that would take effect in late 2012.

House Republicans are pushing for cuts to taxpayer funding of the FDA and other agencies in a drive to reduce government spending, setting up a showdown with Democrats who are resisting major reductions.

Republican Representative John Shimkus told Shuren that increases in FDA funding from Congress were unlikely.

"You can ask all you want. There's no more money," Shimkus said. To create new jobs, "we have to ease the regulatory burden," he said.

Other lawmakers also urged Shuren to streamline the review process to help encourage investment and create jobs. Many mentioned their districts were home to device companies.

Industry witnesses said the FDA was discouraging venture capital investment in new technologies and threatening U.S. jobs with unpredictable and unreasonable demands on companies.

"Over the past few years it has been increasingly more difficult, more time consuming, more costly and less predictable to navigate the FDA approval process," said Josh Makower, an inventor who founded six medical device companies.

"As a result, investment is drying up, companies are moving overseas or closing their doors," he said.

The FDA's Shuren agreed the FDA needed to provide clarity in some areas. But he also said a "significant number" of applications to the agency are "incomplete or fail to address basic elements such as the device's proposed indications for use." That adds time to the review process, he said.

Other witnesses urged the FDA to properly balance a desire for new products with tough oversight of safety risks.

"Although we want to stimulate innovation and job creation, we cannot afford to allow deregulation to place the American public at risk," said Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic and a critic of the FDA's safety oversight.

(Editing by Steve Orlofsky)

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