Regen Biologics blasted the Food and Drug Administration Monday for its decision to revoke its 2-year-old approval of the company’s leading product, a patch to repair the knee’s meniscus tissue.
Sold under the name Menaflex, the patch initially came under scrutiny last year when it became an example of the problems plaguing a review process the FDA relies on to approve countless medical products, ranging from lab kits to heart bypass circuits.
The FDA’s Center for Devices and Radiological Health announced the unprecedented decision last week, saying the agency made an error when it originally cleared the product in 2008.
A group of FDA regulators initially raised questions about Menaflex last year, saying the product’s approval was not based on science but on political pressure exerted by a group of New Jersey lawmakers.
On Monday, Regen’s chief executive blamed the FDA’s decision on politics.
“The agency’s clearance of Menaflex has become a political football and the FDA is not playing by the rules,” CEO Gerald Bisbee said in a statement.
“Regen has invested 58 months and more than $30 million to meet (the center’s) requirements,” Bisbee stated, “only to have the agency reverse decisions made by previous officials by stating that they were in error with no substantial evidence that is true.”
The Hackensack-based company said it is evaluating its options.
But it is already investigating ways of financing its Europeon subsidiary, ReGen Biologics AG, so it can continue to market Menaflex outside the United States.
Menaflex has been sold in parts of Europe for the past nine years.