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FDA To Reassess Approval Of Regen Device >RGBO

By Alicia Mundy and Jared A. Favole

WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration is reconsidering the approval of ReGen Biologics Inc.'s (RGBO) knee device after an investigation showed that unprecedented industry and Congressional involvement influenced the agency's decision and even reached the commissioner's office.

The FDA released a report Thursday saying top FDA officials repeatedly deviated from agency procedures in overriding FDA scientists who rejected the device's approval twice amid concerns about its safety and effectiveness. The director of the FDA's device division who granted approval for the device, Daniel Schultz, has since left the agency.

Joshua Sharfstein, the deputy director of the FDA, said the report shows there were "definite threats" to the integrity of the FDA's medical device review process. The report could have far-reaching effects for not only ReGen, but the entire $200 billion device industry. Sharfstein said the review focused on "underlying weaknesses" in the FDA's rapid-approval process for certain medical devices, also known as the 510-K program.

The FDA yesterday announced that it was reviewing that program and reached out to an influential scientific group, the Institute of Medicine, to also investigate it.

Menaflex was cleared through the rapid-approval process. One of the main questions the FDA wants to answer in the next few months is whether industry and Congressional influence led the agency to improperly allow the device to go through that process.

Sharfstein said, however, the report isn't a reason for patients who have had the device, Menaflex, implanted in their knee to panic because the report focused on the FDA decision, not the science behind that decision.

He said the FDA will now review the entire decision over the next few months and that may result in the product being withdrawn from the market.

ReGen Chief Executive Gerald E. Bisbee said in a statement the report didn't evaluate the scientific evidence of the device, and noted the product is still available. The company has said that it is safe and helps knee-surgery patients recover more quickly.

The questions about the approval of ReGen's knee device were first reported by The Wall Street Journal in March.

The report shows Congressional and industry influence reached as high as the commissioner's office, where, in a rare move for the head of an agency, former FDA Commissioner Andrew von Eschenbach pressured other FDA officials to act quickly on the device. Von Eschenbach didn't make himself available to comment for the FDA report and wasn't immediately available to comment.

A high-ranking FDA official described pressure from Capitol Hill as "the most extreme he had seen, and the agency's acquiescence to the Company's demands for access to the Commissioner and other officials in the Commissioner's office as unprecedented," according to the report.

Congressional pressure was so intense that it "initiated a chaotic new phase" during the agency's review of the device, the report says.

Four Democrats from the New Jersey delegation contacted the FDA to encourage it to speed of its review of the ReGen device. ReGen is based in New Jersey. They are Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. Pallone is chair of the House Energy and Commerce Committee's health subcommittee.

The politicians have said through spokespeople that their involvement was merely to help a constituent get fair treatment at the FDA.

The FDA report says over the device's 17-year approval history "multiple departures from processes, procedures, and practices occurred."

Peter Lurie of the consumer group Public Citizen, which opposed Menaflex's approval last year, said the report "confirms our suspicion that the approval process here was completely corrupted, and we believe a review of the science will result in its being withdrawn."


-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; [e-mail]

http://online.wsj.com/article/BT-CO-20090924-714314.html