ReGen: Resurrection or Final Nail
The FDA wants a "do-over" for ReGen's Collagen Scaffold clearance. Will this be the beginning of the company's resurrection or will it be the final nail in the coffin.
The agency has called a meeting of its orthopedic device panel on March 23 to "discuss and make recommendations on issues relevant" to the agency's reevaluation of its previous clearance of ReGen's product.
The entire medical device industry should be watching this like hawks. ReGen won FDA clearance for its device last year after this same panel said the device was safe.
To the credit of new leaders of the FDA, the agency issued a stinging self critique last year of its handling of the Collagen Scaffold. That criticism pointed to its own bureaucratic and internal political faults and nothing about the product's safety or any specific allegations of unlawful or improper behavior by the company. The criticism also spawned a review of its entire 510(k) process.
“Do-Over Authority”
Gary Bisbee, Ph.D., ReGen's CEO told OTW that there is no provision in the law for a "recession" of a previous clearance decision. The FDA can issue a recall of a product or reclassify the device, but they can't just rescind a clearance. We contacted the FDA to ask about this and to find out exactly what the purpose of the meeting will be. Are panel members being asked make a recommendation on classification? Will they be asked to vote on specific questions? Will the panel be reviewing the same scientific data they considered last year?
The FDA did not respond to our questions.
Due Process and Equal Protection
The issues of due process and equal protection of the laws for this particular device company are in question here. If the agency can arbitrarily call a do-over for ReGen, then it can do it for any cleared device. Where is AdvaMed or the Medical Device Manufacturers Association in this matter?
ReGen has been in limbo ever since the agency announced at the end of last year that it would review its own behavior in granting clearance. Since that announcement, ReGen has laid off its entire staff and gone dormant. It still sells the product in Europe, where it is approved for marketing.
Fellow device makers should be demanding answers from the FDA about its actions in effectively shutting down a company without presenting any evidence of wrongdoing or questions about the safety of the device.
Dangerous Precedents?
If this is arbitrary on the part of the FDA, dangerous precedents are being set.
The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet on March 23, 2010, from 8 a.m. to 5 p.m. at the Hilton Washington, DC North/Gaithersburg. The contact person for the meeting is Tracy Phillips. The phone number is 301-796-6150 and email is Tracy.Phillips@fda.hhs.gov