Pharmaceutical advertisers are always searching for new ways to meet their “fair balance” requirement while simultaneously not “scaring” potential patients and their caregivers. Over the years, there have been a variety of methods adopted. Some focused on using the one-click rule, and others simply had non-compliant communications. There is now a new trend in advertising your product via the Internet.
The Latest Risk Promotion Trend
The most recent trend in meeting fair balance has been to contextualize risks as possible benefits. The most common re-contextualized risks are anti-diabetic drugs that include off-label weight loss claims, blood pressure reduction or sedativesthat allow for “arousability.”
Presenting a Drug Advertisement Claim as a Risk
There are issues with communicating risk information as a benefit. Specifically, the claims may be deemed off-label communications that do not meet the “truthful but not misleading” standard as expressed by the Supreme Court and additionally agreed to by the Second Circuit.
Camouflaged Risk Claims may be deemed to be Misleading
The FDA has seized on this opportunity to comment that such claims may omit material facts and risk information.
Impact of Presenting Risks as a Claim
Despite a company’s best efforts, it is possible to make an error and let inappropriate communications slip through the cracks. Subscribe to our blog to keep abreast of these latest trends in promotional compliance.
Concerted efforts by the company to obscure the risks associated with their drugs might expose the company to misbranding claims and multi-billion dollar fines. It is important that a company take appropriate precautions before making “claims” that don’t have appropriate proof.
FDA Warning Letter: New, Unanswered Questions?
The FDA warning letter sets the stage for the next round of questions that may be posed by the life sciences industry. The Courts have required that the FDA cannot prohibit speech that is truthful and not misleading. However, the FDA requires fair balance – which would require companies to make claims that have only the appropriate amount of evidence. Surprisingly, the same is not required of the adverse events, which simply have to be reported. It seems inherently unfair to require a lower standard of proof for one element of promotional speech than it does for another element. Accordingly, will the next step of first amendment advocacy by life science companies require that adverse events only be reportable to the extent they are proved to be “appropriately” linked? Or would such adverse event disclosure be deemed a type of “forced speech” that may not pass first amendment muster?
To learn more about complaint promotions, come to my talk at DIA’s Medical Affairs and Scientific Communications 2016 Annual Forum and subscribe to the Law firm’s blog here.
Disclaimer: The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.