The FDA expected it, and now it's official: The Justice Department won't be backing away from off-label marketing. That's in spite of the instantly notorious appeals court decision in Caronia v. U.S. The Second Circuit may have called sales rep Alfred Caronia's off-label marketing a matter of free speech. But that leaves plenty of ground open for the feds to prosecute off-label shenanigans.
As the Philadelphia Inquirer reports, U.S. Attorney Zane Memeger says his team will continue to zero in on evidence of "misbranding," the official charge when drugmakers are caught pumping their products for uses not approved by the FDA.
After all, the Caronia decision offered free-speech protection to true statements about a drug's performance. Lies are another story, the Inquirer points out. "There is no right of a company or an individual to make false and misleading statements about the use of a drug," Memeger told the newspaper. "I don't see a difference in prosecuting our cases as vigorously as we have."
The Justice Department has decided not to appeal the Caronia case, which for now only applies in the Second Circuit's states: New York, Connecticut and Vermont. Another free-speech case is under review right now, in another circuit. And eventually, the matter may end up at the Supreme Court. But at the moment, it's more or less business as usual.
- read the Inquirer story