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.
For now, note that this win for federal prosecutors follows a February 2016 loss of another off-label criminal case. “The central allegation in the criminal case was that Root had coached sales staff to sell the Vari-Lase Short Kit to treat veins deep in the leg, even though the FDA had only approved the treatment for veins near the skin’s surface.” Ultimately, the defendant appears to have prevailed on the theory that their promotions were in fact on-label, mooting any First Amendment question (see also the trial judge’s unpublished decision avoiding the issue). As Root argued in an op-ed, “our device was FDA-cleared for treating all varicose veins.” The Wall Street journal cheered.
In other off-label developments, this week, Deborah Mazer and Gregory Curfman offer a thoughtful blogpost over at Health Affairs, expressing a concern that the emerging First Amendment doctrine “threatens to undercut the mandate of and trust in the FDA.” They argue that, “Given the competing interests of patient health, access to information, drug safety, and the financial interest of the pharmaceutical industry, the FDA should have complete authority to provide guidance for off-label promotion in order to ensure the safety and efficacy of drugs.”
Also this month, a new Health Policy Brief reviews the issues and notes that Congress is taking an interest, including provisions in the 21st Century Cures act, which passed the House in July, and the Prescription Drug Users Fee Act, now being negotiated. This legislation would impose deadlines on the FDA’s efforts to finalize proposed rulemaking from September 2015, which the FDA says, “will provide clarity for drug and device manufacturers generally regarding FDA’s interpretation and application of its existing intended use regulations.” Still, its hard to find anything novel here, as the FDA simply reiterates that “the Agency does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.” As I have argued, this distinction between knowledge and intent is longstanding and exists in many other areas of the law as well.