ReGen to FDA: 'Thanks, But No Thanks' Company Says Federal Agency Would Be Only Beneficiary of Part 16 Hearing; Six Years of Legal Errors and Agency 'Agenda' Enough for Medical Device Maker
WASHINGTON, March 22, 2011 /PRNewswire/ -- ReGen Biologics, Inc. (ReGen), manufacturer of the popular and successful Menaflex Collagen Meniscus implant, today declined the U.S. Food and Drug Administration's (FDA) offer of a hearing under 21 CFR Part 16 before the agency formalizes its decision to rescind clearance of the device.
According to ReGen Chair and CEO Gerald E. Bisbee, Jr., Ph.D., the company's experience with the FDA over the past six years makes it clear that any such hearing would be futile. "The safety and effectiveness issues surrounding the clearance of our device were settled years ago at a November 14, 2008 Advisory Panel meeting. The independent experts on that Panel were completely in Menaflex's favor," he said. "The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren't on the table in a Part 16 review. Enough is enough."
ReGen's Menaflex device is a resorbable surgical mesh used in meniscus surgeries to reinforce damaged or weakened meniscal soft tissues, which provides a scaffold for replacement by a patient's own soft tissue. It was approved in Europe in 2000 under the most stringent review classification for use in medial meniscus injuries, and in 2006 for lateral meniscus injuries. To date, the device has been used successfully in over 3000 European surgeries, with no safety issues. In fact, a recent independent publication from a prestigious European academic center shows that 10 years after surgery, Menaflex patients show superiority to patients receiving the standard of care, partial meniscectomy.
In December 2008, following 3 years of review under the 510(k) process including input from an Advisory Panel of independent experts, the FDA ruled that the product is as safe and effective as other surgical meshes and cleared it for use by surgeons in the U.S. Two years later, following a change in top management at FDA, the agency took the unprecedented action of re-reviewing its own approval. Dr. Jeffery Shuren, who is the Director of the Center for Devices and Radiological Health (CDRH), justified the re-review by citing a September 2009 FDA Report of which he was co-author, entitled "Review of the ReGen Menaflex: Departures from Process, Procedures, and Practices Leave the Basis for a Review Decision in Question."
That report concludes that the original review of the device suffered from multiple internal FDA departures from processes, procedures, and practices, departures that were compounded by external pressures. A careful reading of the report, however, reveals that within the reviewing division there was "... widespread internal disagreement and confusion about the legal standard for 510(k) review." It also states that "OCC [FDA's legal division] advised that review of a 510(k) involves a comparison of a device to a predicate rather than to a standard of care and that there was no legal foundation for requiring a company to demonstrate clinical benefit in a 510(k). This interpretation supported ReGen's long-standing argument that the Center was holding the CS device to the wrong review standard."
In March 2010, ReGen sent a letter to FDA Commissioner Hamburg regarding this report. That 66-page letter provided a detailed analysis stating that the report "...contains 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, i.e., a re-examination of the Menaflex device 510(k) clearance." Commissioner Hamburg has yet to even respond to a request in this letter to correct or retract the errors in the report as required by law.
The "re-review" took almost one full year, included a second, unprecedented, Advisory Panel Meeting, and culminated in the decision that the device had a different intended use. According to this decision, ReGen's surgical mesh, despite its similarity to approved meshes, would not be regulated as a surgical mesh pursuant to 510(k)but instead would be treated as a novel Class III device. Dr. Shuren has stated his intention to "rescind" the FDA's original 510(k) clearance – an unprecedented step that has unsettled the FDA regulatory community. Dr. Bisbee states: "It's unbelievable that after more than five years of 510(k) review of this product -- and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh -- Dr. Shuren now says that they were wrong. This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval."
In opting out of the FDA's Part 16 hearing, ReGen put the agency on notice that it will seek an unbiased review of Menaflex's approval status under U.S. law. "We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage," said Dr. Bisbee. "After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA's administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients."
The FDA's decision that device clearances can be re-reviewed and rescinded long after they have been approved will chill U.S. investors' enthusiasm for investing in the development and distribution of new devices, although a wide range of medical product innovations are desperately needed here and abroad.
About ReGen Biologics, Inc.
ReGen Biologics is an orthopedic products company that develops, manufactures and markets innovative tissue growth and repair products for U.S. and global markets. ReGen's Menaflex™ collagen meniscus implant employs proprietary biological collagen scaffold technology to facilitate tissue growth, thereby reinforcing and repairing the damaged meniscus of the knee. The Menaflex device has been cleared for sale in Europe and other countries, and is marketed through ReGen's European subsidiary, ReGen Biologics AG. The FDA cleared the Menaflex device for marketing in the United States in December 2008; its announcement of intent to rescind that decision is the subject of this press release. Visit www.regenbio.com and www.menaflex.com for more information.
SOURCE ReGen Biologics, Inc.