Attorney: Regenexx presents FDA with political quandary
WASHINGTON - Some medical device cases have a social and political reach that defy the grasp of the underlying technology, and a speaker at this year's annual meeting of the Food and Drug Law Institute (FDLI; Washington) hinted that the case of U.S. v. Regenerative Sciences may be tough for FDA to digest. The case revolves around a treatment that involves processing of a patient's own stem cells, which Regenerative Sciences has argued is a practice-of-medicine proposition whereas FDA sees it as a process requiring a regulatory filing. Margaret Riley, an attorney with the University of Virginia School of Law, said the situation is fraught with political overtones and may prompt the kind of discomfort seen at FDA when dietary supplements were a point of contention in 1999. Sen. Tom Harkin had derided FDA's reluctance to move on dietary supplements in a public forum at the time, describing the agency as the Fear and Denial Administration (FDLI annual conference).