Recent Developments in Off-Label Promotion

By Chris Robertson

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. Continue reading

Jon Mark Hirshon on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5
Listen here! Our guest this week is Jon Mark Hirshon, M.D., M.P.H., Ph.D., an Associate Professor in the Department of Emergency Medicine and in the Department of Epidemiology and Public Health at the University of Maryland School of Medicine. Jon Mark is also on the board of the American College of Emergency Physicians, and is an internationally recognized expert on acute care. His teams have trained approximately 900 physicians from countries in the Middle East in topics ranging from clinical care of trauma patients to disaster preparedness to research methods.Our lightning round featured discussions of an issue brief, “How Has the Affordable Care Act Affected Health Insurers’ Financial Performance?,” as well as a news story on some insurers’ dissatisfaction with the ACA. While health costs may increase GDP, they are hurting some insurers’ bottom lines. On the health IT front, we focused on ransomware and non-covered entities’ data. And continuing our wellness coverage, we mentioned employers’ new enthusiasm for mobile monitoring of employees’ mental health–what Rachel Emma Silverman’s twitter feed has jokingly called “#textualhealing.”

During his interview, Jon Mark focused on policy issues in acute care. He discussed a lawsuit filed by the American College of Emergency Physicians against the federal government reflecting ACEP’s concerns about reimbursement. Jon Mark also described the many challenges now facing emergency departments, ranging from narrow networks that fail to fairly compensate care, to user-unfriendly IT systems. Jon Mark also offered practical solutions for increasing access to acute care–an urgent policy concern given America’s dismal overall grades for access to emergency care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw