The Second Circuit Stands Up For Free Speech
/In a victory that has been decades in coming, the Second Circuit has reversed a conviction of a pharmaceutical salesman for promoting so-called "off-label" uses of an FDA approved drug. The opinion is available at this link via the Washington Legal Foundation, which has done important work in this area.
I have been incredulous for many years that the FDA thinks it has the right to restrict the truthful statements of pharmaceutical companies about their products after the drugs have been specifically approved as to safety and effectiveness. Under extremely dubious statutory authority (read the Second Circuit opinion to find out how dubious) the FDA goes after drug marketers not just civilly, but criminally, for daring to inform doctors about uses of the drugs, often derived from published medical literature.
Here's a link to an article I wrote in 1999, "Top Ten Federal Government Efforts To Suppress Free Speech," identifying the FDA's off-label marketing restrictions as the number one such effort, and charitably describing the FDA as "the most Stalinist of Federal agencies." Same has been true ever since.
The off-label marketing restrictions are probably the most lucrative government shake-down of the private sector out there. Years ago the prosecutors figured out that, despite the obvious First Amendment problems and pitifully weak legal theories involved with the off-label marketing campaign, the pharmaceutical companies could not risk a conviction, and would cave every time for big bucks. Here's a Bloomberg News article from 2009 listing one gigantic settlement after another: $430 million from Pfizer in 2004, $1.19 billion from Pfizer in 2009, other settlements from Eli Lilly and Bristol-Myers Squibb totaling multiple billions.
This time they got a poor individual in their cross-hairs; but an individual can sometimes be in a position to suffer the conviction and take the appeal.
Hard to tell from the Second Circuit's opinion if they have actually put an end to the entire program. They go off on narrower grounds than they might have. Shouldn't there be some penalty on the prosecutors for bringing these types of cases? Perhaps at least a remedial course on the First Amendment?