The “Second Front” in the Widening Off-Label War

In our inaugural post last week, we discussed how concerned federal prosecutors must be about the prospect that the U.S. Second Circuit Court of Appeals may soon rule that the FDA’s ban against off-label promotion violates protected free speech.  In U.S. v Caronia, the Government argued on appeal that the FDA wasn’t criminalizing off-label speech, per se, but rather, was just using off-label speech as “evidence of intent” to introduce a misbranded drug into commerce.  When the Government’s lawyer was unable to cite a single instance in which anything other than off-label speech was used as evidence of misbranding, the fallacy of the Government’s argument and the truth about its uncompromising campaign against off-label speech were exposed.

And, in October the Government got more bad news. Par Pharmaceuticals, a mostly generic drug company, filed a suit seeking a delaratory judgment and an injunction against the FDA, claiming (as Allergan once did) that the FDA’s off-label rules violate the First Amendment.  What makes the Par case different from both Allergan and Caronia, is that Par isn’t interested in promoting off-label; instead, it wants to promote Megace-ES, a drug first approved in 1993, for its FDA-approved use in treating weight loss/wasting in AIDS patients.  So, why did Par sue?  According to the Complaint, Par is under investigation in New Jersey for promoting Megace-ES on-label, but to an audience that the Company seems to know may prescribe the drug for the well-known and generally accepted off-label medical use of treating weight loss/wasting in non-AIDS patients (e.g., cancer patients and the elderly).  In essence, Par is arguing that the FDA’s “intended use” regulation is so draconian, it can’t even engage in approved on-label speech out of fear that doctors hearing the speech might use the drug off-label.  The Government’s response to Par’s complaint is due on December 23^rd.

Ironically, Par’s suit may help the Government’s cause somewhat.  Most likely, the Government will seize upon the facts in Par as proof that the FDA isn’t criminalizing speech, be it on-label or off-label, but as mere evidence of Par’s intent to introduce a misbranded drug into commerce (i.e., as evidence of intent to sell the drug for an off-label use)  — an argument the Government raised in Allergan and Caronia.  Hopefully, however, the Court will realize that the evidence the Government wants to use to prove Par’s off-label intent is based both on Par’s on-label promotional speech and on where the speech takes place (for example, in a nursing home where most of the patients fighting weight wasting don’t have AIDS).  Indeed, absent Par’s on-label speech (regardless of venue), an intent to promote Megace-ES for any use is impossible to prove.

For those of us who have been troubled by the use of Government muscle to extract multi-million and multi-billion dollar settlements from companies for providing information (that has rarely been fraudulent or inaccurate) to an audience of physicians that has the co-equal free speech right to get the
information, the hope here is that the courts in Caronia, Par or both will step in and strike the right balance.  While no one should expect (or want) a ruling that bars the FDA from regulating off-label promotion altogether, the status quo of banning all manufacturer off-label speech – no matter how truthful, accurate, well-balanced or useful to the practice of medicine – needs fixing.