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WASHINGTON — A medical device company at the center of a highly controversial Food and Drug Administration approval is pushing back against the agency's plan to re-evaluate the implant.
Regen Biologic's knee repair implant spent more than three contentious years under review at the FDA before gaining approval in 2008. When newly appointed Obama administration officials re-examined the approval last year, they concluded that FDA's decision was influenced by intense lobbying by lawmakers from Regen's home state of New Jersey.
FDA is supposed to make decisions based on scientific analysis, but Regen's Menaflex device was cleared despite repeated objections by staff scientists. The two lead FDA officials who oversaw the decision have since left the agency.
Next week the FDA will convene a panel of experts to revisit the safety and effectiveness of the device, an extremely rare step for a device already approved.
Approximately 210 patients in the U.S. and 3,000 in Europe have had Menaflex implanted.
FDA on Friday posted its agenda and discussion questions for the meeting. Regen preemptively responded by questioning the legitimacy of the agency's plans.
"We believe this panel meeting to 're-review' the Menaflex clearance is unprecedented and the FDA has no legal basis," said the company in a statement.
The company also complained that the FDA did not give the company adequate time to review the briefing documents for the meeting.
An FDA spokeswoman said in a statement "the agency has followed standard procedure in scheduling and preparing for this panel meeting."
According to the documents posted to its Web site, FDA plans to ask the panel of orthopedic surgeons about "limitations," with Regen's original application, including missing data.
FDA is not required to follow the guidance of its panels, though it often does.
Hackensack, N.J.-based Regen approached the FDA in 2005 to request its device be approved under the so-called 510k system. Under the procedure, companies can win speedy approval for devices that are similar to products already on the market.
The FDA told the company that its implant did not meet the 510k criteria and would have to go through the traditional approval process — a more expensive, time-consuming process involving clinical testing.
After the FDA twice rejected the company's request for fast-track approval, Regen enlisted the support of New Jersey lawmakers, who called then-FDA Commissioner Andrew von Eschenbach on the company's behalf.
The agency then scheduled a special public meeting to discuss the company's device and ultimately approved it in December 2008.
