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FDA Bill Should Speed Up Approvals

FDA Bill Should Speed Up Approvals

Biotech: User Fees Will Fund Faster Reviews of New Medical Devices

BY MARION WEBB

Senior Staff Writer

Legislation recently approved by Congress should help both patients and biotech companies by speeding up the review and approval of new medical devices.

HR 5651, passed on Oct. 17, comes with a price attached for small and big manufacturers alike.

Manufacturers that generate $30 million or more in gross revenue would pay user fees set at $2,187 for each federal review of a 510-k medical device application, and $154,000 for a new premarketing application, according to Kathleen Kolar, a Food and Drug Administration spokeswoman.

The bill’s aim is to speed up the introduction to the marketplace of new medical devices that could improve patient’s quality of life and help diagnose diseases faster. The bill still must be signed into law by President George W. Bush, an FDA official said.

Both the 510-k and premarketing applications seek to ensure that a new device is safe and effective, but the review processes are vastly different.

A 510-k is filed in cases when a device can be compared to a similar already approved product. Premarketing applications, by contrast, require companies to do extensive scientific studies and typically take 180 days to be reviewed, or twice a long as a 510-k.

Lobbyists for the industry said the average total review time for premarket submissions is 411 days, and that the new legislation will cut that time by 100 days. Similarly, 510-k applications have been known to exceed the statutory review time of 90 days.

Kenneth Kleinhenz, director for regulatory affairs at San Diego-based MacroPore Biosurgery Inc., which develops and sells medical devices used during surgery, said the FDA took between 120 and 150 days to review its 510-k applications.

Joseph Panetta, CEO and president of Biocom, the San Diego-based trade group for life science companies, said “most companies would like to see a system of expedited approvals.”

Proponents of the bill say the new fees, combined with funds from increased appropriations, will provide the agency’s device program with $225 million in additional resources over the next five years.

The money will be used to hire additional reviewers and establish a new office to oversee certain technologies, the medical device industry association reported.

Kleinhenz, however, remains skeptical.

“It’s a double-edged sword,” he said. “User fees would allow the FDA to hire more reviewers, which could speed up the review process , but it’s not a guarantee.”

The process even for 510-k applications can be onerous, particularly when a company seeks product approval for multiple uses.

Kleinhenz said within the agency are various department for products used only in orthopedics, cardiology and neurology, which means talking to different reviewers.

Thus far, MacroPore has succeeded in getting 13 510k approvals for four product lines.

Under the new legislation, companies could also for the first time hire outside experts to inspect their plants for federal compliance.

The inspectors would have to be accredited by the government and report to the FDA.

Some people, however, see a potential conflict of interest in hiring private inspectors.

“If John Doe was hired by company XYZ to do an inspection at a company he has previously been a consultant for, it may have the appearance of a conflict of interest,” said Michael Swit, an attorney specializing in FDA regulatory law at the life sciences group at the law firm Heller Ehrman White & McAuliffe LLP in San Diego.

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