Healthy Skepticism Library item: 17687

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Commercial Free Speech Or Off-Label Marketing?
Pharmalot 2010 Apr 27
http://www.pharmalot.com/2010/04/commercial-free-speech-or-off-label-marketing/

Full text:

Back in 2002, Orphan Medical obtained FDA approval to market its Xyrem drug to treat cataplexy, which is a sudden loss of muscle tone associated with narcolepsy, although docs soon began prescribing the med to treat other conditions. And Alfred Caronia, a former Orphan sales exec, was convicted three years later of encouraging docs to engage in off-label usage.

However, the Washington Legal Foundation, which has long been active in championing off-label promotion as a form of commercial free speech, has filed a brief urging the US Court of Appeals
for the Second Circuit to overturn Caronia’s conviction on the grounds that the “First Amendment broadly protects the right of individuals to speak truthfully about off-label uses of FDA-approved products, even in a commercial context.” The non-profit notes there was no allegation Caronia said anything false, but is “prosecuting him solely because it did not approve of his truthful statements.”

According to the indictment, the active ingredient in Xyrem was GHB, a powerful and fast-acting central nervous system depressant that was subject to abuse and classified by authorities as a ‘date rape’ drug and, therefore, distribution was tightly restricted as a Schedule III controlled substance. Caronia was accused of ‘conspiring’ with a psychiatrist to promote off-label uses, according to the documents. The WLF argues, though, that the “uses in question are now ‘on-label’ because they have all now been approved by FDA, in one instances within a matter of days after Caronia’s promotional activities took place.”

This argument is essentially the same one that Allergan, which sells Botox, claims in a recent lawsuit filed against the FDA, alleging the agency ban on off-label marketing violates its First Amendment rights to free speech (see Allergan statement). And the WLF is one of several groups that filed friend of the court briefs supporting Allergan’s request for a preliminary injunction to block the FDA from providing off-label info to healthcare providers.

This is certainly a thorny issue. On one hand, the FDA has authority and duty to protect public safety. On other hand, companies want the right to freely discuss the virtues of their product. A key question, of course, is whether the current system strikes the right balance. Meanwhile, Caronia was convicted for chatting up uses that the FDA later approved. What do you think?