nowBuzz up!FDA withdraws controversial approval of knee implant
Friday, October 15, 2010
BY KATHLEEN LYNN
The Record
STAFF WRITER
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HACKENSACK — The Food and Drug Administration is withdrawing its approval of a knee implant created by ReGen Biologics Inc. of Hackensack, a year after saying the approval had been influenced by four members of New Jersey's congressional delegation.
The Menaflex device, which was approved in December 2008, "should not have been cleared for marketing in the United States," the FDA said in a statement Thursday. The device was designed to help repair knee cartilage called the meniscus.
ReGen's CEO, Gerald E. Bisbee Jr., said in a statement that the financially troubled, 20-year-old company "is currently weighing its options."
"The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients, and there has never been a safety issue associated with the device," Bisbee's statement said.
The FDA said Thursday that patients who have had the device implanted probably would not need to have it removed because it is absorbed and replaced with new tissue. The FDA advised patients to consult their doctors.
In a review last spring, an FDA panel called the product "reasonably safe" but said there was not enough evidence to say it's effective.
In its statement Thursday, the FDA said Menaflex should not have been given a "fast-track" approval based on the performance of similar devices, because there are too many differences between the products.
Menaflex was designed to provide a scaffold to encourage the growth of new tissue after the meniscus is torn, a common injury.
Menaflex, which sold for about $1,600 per unit, is one of two ReGen products. The other is a suturing device used with Menaflex.
In the past, ReGen accused the FDA of treating it unfairly and said that it turned to the congressional delegation only after becoming frustrated with the FDA review process. ReGen gave a total of $28,000 to U.S. Sens. Bob Menendez and Frank Lautenberg and Reps.
Steve Rothman and Frank Pallone in 2007 and 2008.
The FDA said in September 2009 that its decision to approve the Menaflex was influenced by pressure from the four officials. It also said that a former head of the agency, Andrew von Eschenbach, became involved in details usually left to the scientific staff, allegedly in response to the congressional pressure. Von Eschenbach denied acting improperly.
It was the first time that the agency had publicly questioned its own approval process or admitted to political influence.
At the time, all four Democratic lawmakers denied pressuring the agency, saying that they had only requested fair treatment for ReGen.
Rothman issued a statement Thursday criticizing the FDA, which he said "has mismanaged this issue and this product from the very beginning."
"It's unfortunate that a product that could have helped thousands of Americans each year is no longer available on the market," Rothman said. "This product could have saved people pain, recovery time and health care costs."
ReGen's stock, which trades over the counter, closed Thursday unchanged, at 17 cents.
E-mail: lynn@northjersey.com
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Yeah - I got illegals all over the nabe I want booted out. How much is it going to cost me to get my Dem congressscum to get off their asses to take action on it?
