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ReGen Biologics has rejected the FDA’s offer of a hearing, before the agency formalises its plans to annul its 510(k) clearance of the company’s Menaflex meniscal implant.

Dr Gerald E Bisbee, Chair and CEO of Regen, thinks that any meeting would be a big waste of time and he might have a point judging by his company’s dealings with the FDA over the past six years. Bisbee says “enough is enough”, because safety and efficacy issues regarding the device were reportedly settled years ago at an FDA Advisory Panel meeting.  Bisbee said members of that panel were in favour of Menaflex, and any issues that need attention are the FDA’s own “arbitrary and unfair processes”.

Menaflex is a reabsorbable mesh that is used in meniscus surgeries to reinforce damaged or weakened meniscal soft tissues, providing a scaffold for replacement by the patient’s own soft tissue. The device was cleared in Europe in 2000 and 2006 for use in medical meniscus injuries and lateral meniscus injuries, respectively. After a three-year review under the 510(k) process (which included input from  the Advisory Panel of independent experts), December 2008 saw the FDA rule that the device is safe and effective, and cleared it for use. But after a change of management at the FDA two years later, the agency re-reviewed its own approval of the product. Dr Jeffrey Shuren, Director for the CDRH, rationalised the re-review by citing a September 2009 FDA report, of which he was co-author, called “Review of the ReGen Menaflex: Departures from Process, Procedures and Practices Leave the Basis for a Review Decision in Question”.

The report said that the original FDA review of the device was subject to a number of internal FDA departures from processes, procedures and practice that were compounded by external pressures. Bisbee believes that a careful reading of the report shows that within the reviewing there was “…widespread internal disagreement and confusion about the legal standard for 510(k) review”, and that the OCC (the FDA’s legal division), “advised that a review of a 510(k) involves a comparison of a device to a predicate rather than to a standard-of-care that there was no legal foundation for requiring a company to demonstrate clinical benefit in a 510(k)”. Bisbee says this interpretation supports ReGen’s argument that the CDRH was holding the device to the wrong review standard.

Almost exactly a year ago, ReGen wrote to the FDA Commissioner Hamburg about the report. The letter provided 0a detailed analysis of the report, suggesting that it contained “…inaccuracies, misrepresentations, speculation and bias, and omits material information… The extent and depth of these irregularities raise the question of whether the preliminary report was intended to discuss the results of the agency’s internal investigation or instead provide support for a foregone conclusion, ie, a re-examination of the Menaflex device 510(k) clearance”.  According to ReGen, Commissioner Hamburg is yet to respond to the letter.

The FDA’s re-review of Menaflex took almost a year and included a second Advisory Panel meeting, concluding with the decision that the device had a different intended use. According to this decision, Menaflex, despite being similar to other approved meshes, would not be regulated as a surgical mesh pursuant to 510(k), but would be treated as a novel Class III device. Shuren stated his intention to revoke the FDA’s original 510(k) clearance, a move that Bisbee finds “unbelievable”.

As it has declined the FDA’s offer of a hearing, ReGen has put the agency on notice that it will seek an “unbiased” review of Menaflex’ approval status under US law. ReGen says it knows the FDA has no legal authority to revoke Menaflex’ clearance, and believes the agency botched its review of the product at every stage. In a nut shell, will the FDA’s opinion that devices can be re-reviewed and revoked at any time, even long after they have been approved, chill US investors’ eagerness to invest in the development and distribution of new devices?

Thanks to Sophie Bracken for this article, Sophie is editor of Orthopaedic Business News Espicom’s monthly digest of news from the industry.

Thanks for reading, Paul.

Espicom Business Intelligence

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