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Court decision changes off-label use discussion
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A recent ruling in the U.S. Court of Appeals for the Second Circuit may have monumental implications for both medical education and the promotion of drugs and medical devices to medical providers. Alfred Caronia, a representative of Orphan Medical (now Jazz Pharmaceuticals), was accused of violating U.S. Food and Drug Administration regulations regarding the off-label promotion of Xyrem (sodium oxybate) when he spoke before a group of doctors about Xyrem’s use in a setting that is not included in the drug’s official FDA labeling. The court ruled that Caronia was not guilty of violating any law because his right to free speech precluded the FDA restriction against off-label discussion.
Under FDA guidelines, company representatives – and anyone speaking at an industry-sponsored medical event – may not speak about or promote uses of any medical product or device outside the strict guidelines of its official FDA indication.
The FDA means business here. In 2010, Allergan paid a $600 million fine for promoting Botox (onabotulinum toxin A) for treatment of migraines, just months before the same agency approved the same drug for the very same indication. No matter that the FDA knew Botox was safe for migraine treatment at the time of the Allergan fine, having been in possession of reams of safety data at that point. No matter that it was already a common, if off-label, use for this same indication. No matter that educating physicians in the safe use of Botox for migraines was in everyone’s best interest, especially the patient’s.
This and other severe fines levied against pharmaceutical manufacturers have sent the drug and device industry reeling with fear of Draconian repercussions for simply educating physicians about the real-world (and yes, off-label) use of their products.
Still, doctors are permitted by their state licenses to use medications in a manner consistent with good medical care, and the best use of many drugs is outside of the approved indication. Most of us would agree that the most valuable medical meetings we attend are small programs put together by a group of physicians, often with industry sponsorship to keep costs down. At these meetings, colleagues collaborate on how we take care of challenging patients. Off-label discussion is common, but commercial bias is generally absent. Until this recent ruling, such meetings would be considered “promotional” (unless they were CME accredited, which adds considerably to the complexity and cost of organizing such a meeting), and this would severely restrict the discussion that could take place.
The new court ruling suggests that the discussion of off-label uses of products is a matter of free speech that can’t be squelched by the FDA. If other courts use this ruling as a precedent, it will bring value (and legality) back to the kind of small, collaborative meetings we all love to attend. It would reduce the cost of medical education by allowing these open discussions without expensive, time-consuming and cumbersome CME accreditation. Quite frankly, it would make most medical meetings much more interesting and relevant to attend.
Further court rulings and case examples will certainly elaborate where the currently gray line exists between FDA regulations and the First Amendment. I’m eager to see the pendulum of regulation swing further toward freedom for doctors and our industry colleagues to collaborate openly about how we practice medicine in the real world.