Drug and device makers can chalk up another off-label victory. As the FDA Law Blog reports, a jury delivered a "not guilty" verdict in a case alleging that a device maker and its top executive conspired to violate the Food, Drug and Cosmetic Act by promoting its product for unapproved uses.
Once again, the First Amendment appears to have played a role in that decision. Before the jury left to deliberate, Judge Royce Lamberth instructed the group about the limits on FDA's power to restrict truthful, nonmisleading statements.
Federal prosecutors had indicted Vascular Solutions Inc. ($VASC) and CEO Howard Root violated the rules by promoting the Vari-Lase device for a type of varicose veins that it wasn't approved to treat.
In jury instructions filed with the U.S. District Court for the Western District of Texas, Lamberth stated that it's not a crime "for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device."
He went on to say, as quoted by the blog, "If you find that VSI's promotional speech to doctors was solely truthful and not misleading, then you must find the Defendants not guilty of the misbranding offense."
The not guilty verdict is the latest in a series of court developments that appear to be shifting the FDA's abilities to crack down on marketing for unapproved uses of drugs. The big kickoff was a Supreme Court decision in the United States v. Caronia case, which stated that the FDC Act couldn't be interpreted to prohibit truthful, off-label promotion.
"This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act," the blog notes.
The agency has promised new guidance on off-label marketing, but so far, it hasn't been forthcoming.
- see the blog post