Vascular Solutions Not-Guilty Verdict Another Challenge To FDA Off-Label Oversight
This article was originally published in The Gray Sheet
The case against the venous device manufacturer turned on the rights of manufacturers to use truthful off-label speech to promote their products. It joins a growing body of cases in which courts have sanctioned broader off-label speech than has traditionally been allowed by FDA.
You may also be interested in...
Off-label marketing and kickbacks may no longer be the top targets of government healthcare fraud investigations as more companies are being hit with subpoenas for pricing information.
Two former executives from J&J's Acclarent division were found not guilty of felony charges but convicted on misdemeanor counts. Prior to being acquired by J&J, Acclarent allegedly marketed its Relieva Stratus sinus dilation device as a steroid-delivery system, even though the FDA had cleared the device only to deliver saline.
While FDA has stuck to a narrow interpretation of precedents like the Caronia ruling, arguing that the decision does not in any way change the landscape for off-label promotion, a series of subsequent court decisions used the Second Circuit’s precedent to solidify company’s free speech protections.