Reorganization of FDA's device center results in more manpower for monitoring claims
Device advice was in abundance at today's Food and Drug Law Institute panel discussion on the industry's compliance with promotion and advertising regs, featuring prominent industry lawyers from Medtronic ($MDT), Covidien ($COV), Abbott ($ABT) and law firms.
Expect more scrutiny due to last year's reorganization of the FDA's devices arm, the Center for Devices and Radiological Health (CDRH). Due to the increased manpower devoted to monitoring advertising, the FDA has already issued a warning letter telling Cook Vascular that the company must cease marketing changes to its Bi-directional Dilator Sheath Sets because they require a new 510(k), one of the attorneys on the expert panel said.
The case highlights a key difference between drugs and devices. The latter product category is allowed to make and market small tweaks to its products, but sometimes the modification crosses a line. Companies must ask themselves, "How far beyond the indication language are you going?" said Medtronic Principal Legal Counsel David Bloch. He added that the FDA is focusing on claims about clinical outcomes made by devices that are used for diagnosis.
Traditionally, warning letters have originated from the FDA's field offices or companies telling on each other, but now CDRH monitors websites regularly, and even tries to conceal its identity on the Internet, so as not to tip companies off or cause a panic, said attorney Casper Uldriks, president of consulting firm Encore Insight.
Many of the new CDRH employees are from the FDA's drug centers and will take about three years to learn the concepts of medical device promotion, Uldriks said. He urged companies to diplomatically ask for a review if they feel like "something doesn't make sense," saying that might be the result of inexperienced monitors at CDRH.
Attorney Marian Lee, partner at King & Spalding LLP, explained that under the congressional statute, the Federal Trade Commission is technically responsible for monitoring the advertising and promotion of most medical devices (but not drugs), making CDRH guidance on the topic unlikely. And the panelists urged the industry to beware of not just the FDA, but FTC regulations as well, such as the agency's guidelines on personal endorsements.
A common quandary in med device compliance relates to what sales reps should say when asked about off-label use of a product. Sometimes questions about off-label use occur even when the patient is lying on the operating table, a situation that the lawyers said should be avoided. The panelists said the sales rep should refer the question to the company's medical experts in that situation.
One example of off-label use discussed was the use of biliary stents (meant for the bile duct) in cardiovascular indications. Physicians are allowed to use products for off-label purposes, but companies may not promote such use, and ignorance can be punished as well.
Lee added somewhat ominously that the medical device industry is becoming a target of focus of the Department of Justice, citing conferences that she has attended. -- Varun Saxena (email | Twitter)