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Understand their approval was controversial, It was not 100% "by the book". Amarin's SPA was rescinded AGAIST medical justification (safety) and DID NOT follow regulatory procedure.
For ReGen Biologics, a tiny Hackensack company caught up in a rare episode of regulatory second-guessing, the strategy of salvaging its fledgling business centers on a subsidiary in Switzerland.
Gerald Bisbee, ReGen’s chief executive, said he is hoping to raise enough money from investors to launch a marketing campaign and begin training physicians in an effort to bolster sales of the company’s Menaflex knee joint repair device in Europe.
The company has few other options — at least, for now.
Earlier this month, the Food and Drug Administration notified ReGen that regulators intended to revoke a two-year-old approval of the company’s implantable mesh patch, which is used to repair injured meniscus cartilage in the knee. The action was unusual enough, but the FDA made an even more unusual admission to explain the decision: After a year-long review, the agency said it had approved Menaflex in error.
The story of ReGen’s pursuit of marketing approval for Menaflex provided a glimpse into the workings of the FDA’s Center for Devices and Radiological Health under former Commissioner Andrew von Eschenbach. It also brought more scrutiny to the agency’s 510k process, which allows companies to undergo shorter, less rigorous reviews if they can show their products are similar to devices already on the market.
When ReGen asked the center to approve Menaflex in 2005, it argued that its surgical mesh device was similar to existing products used to repair tears on the rotator cuff and fistulas. For years, the center’s reviewers argued that Menaflex was different enough to require one of their more rigorous evaluations.
The arguments — intensified by political pressure from a contingent of New Jersey elected officials — were still occurring in 2008 when the center’s director overruled the reviewers and gave Menaflex marketing clearance.
Whistle-blowers brought the handling of Menaflex to the attention of Congress after the 510k process started coming under scrutiny for becoming a shortcut for companies seeking approval for high-risk devices.
In an Oct. 14 letter to Bisbee, the center said it would not revoke Menaflex until officials have a chance to meet with ReGen’s executives to discuss their options for re-submitting the product for marketing clearance.
Mark DuVal, a lawyer from Minneapolis who has guided devices through the FDA’s review processes, said it could take ReGen up to 10 years to obtain marketing clearance if Menaflex is required to go through the most rigorous pre-market approval process.
"The rest of the industry should be concerned,’’ DuVal said.
Meanwhile, ReGen is trying to preserve — and grow — what remains of its business.
"The U.S. business is pretty much not anything at all,’’ Bisbee said. "We can’t raise money when investors are concerned that (regulators) are going to do things to cost us money and hassle us.’’
Europe is a different story. The device, which was approved by Europeon regulators nine years ago, has not come under the same scrutiny.
ReGen sold about 800 of its mesh scaffolding devices in Europe during 2009, a roughly five percent increase over the previous year.
"The market outside the U.S. is a fairly healthy market, but we haven’t put much money in the Swiss subsidiary," Bisbee said. "Most people feel if there was more money for marketing and training and so on, then it would grow much faster than it has.’’
