July has been a busy month for those following the controversy around off-label promotion of drugs and devices. As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses. If the company reveals that it intends unapproved uses, sales of the drug or device are illegal. Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.
This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere. This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.
On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.” The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use. The jury instructions and verdict form are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds. I’ll return with some analysis later. Read More
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