In a very interesting development, FDA’s Office of Prescription Drug Promotion issued a Warning Letter to a drug company, where the CEO was cited for oral statements made during two appearances on the CNBC cable television financial show, “Fast Money.” The show is intended for the investment community. This article will note FDA’s position and highlight our observations and recommendations.
- The CEO’s statements indicated that the prescription drug product could be used for indications for which the drug was not approved (i.e., off-label uses).
- By suggesting the product was safe and effective for unapproved uses, the labeling lacked adequate directions for use.
- The CEO’s statements failed to provide any risks associated with the product, despite the product containing a Boxed Warning regarding potential liver toxicity and an associated Risk Evaluation and Mitigation Strategy (REMS) program.
- As a result of the CEO’s claims (and omissions), FDA said the product was misbranded.
- The Warning Letter instructed the company to stop promoting the product for off-label uses and to identify other promotional materials that contained similar unlawful messages.
- The company must provide FDA with a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages … to correct any misimpressions” about the product’s approved uses.
AGG Observations and Recommendations
- As we have continuously advised clients, FDA can (and will) take enforcement action against product messages directed to the investment community that it considers to be unlawful. That is, investor-targeted communications, if in conflict with statutory and regulatory requirements, are not immune from FDA enforcement. This letter is unique in that the sole forum was a cable television financial show. We note that, typically, when FDA has taken action against investor-related messaging, there have been other unlawful communications in non-investor-related forums.
- FDA issued the enforcement letter based solely on the CEO’s oral statements. There is no reference in the letter that written materials were used, so there was no “labeling.” However, the agency can take enforcement action against off-label promotion where oral statements change the product’s intended use.
- The type of communication sent by FDA was a Warning Letter due to the safety issues raised, e.g., the product’s Boxed Warning and REMS program. FDA is not required to issue first a Notice of Violation or to use other informal communications to bring concerns to the regulated community before issuing a Warning Letter.
- There is no indication in the Warning Letter that the CEO was responding to requests for off-label information. Thus, it appears that the statements were conveyed proactively.
- The CEO made several efficacy claims, but offered no risk information. While it may seem difficult for a CEO, in a live interview, to provide fair balance, FDA is reminding industry that the same promotional rules apply, regardless of the venue. With the good must come the bad.
- The second television appearance occurred on October 31, 2013. FDA issued the Warning Letter on November 8. Fast money – – fast enforcement.
- Bottom line: In our experience, at times, FDA issues Warning Letters as a wake-up call to industry. This specific Warning Letter reminds companies that: (a) oral statements are subject to agency review; (b) investor-related materials with product messages are subject to FDA scrutiny; (c) proactive off-label promotion in any forum is problematic; (d) omission of all risk information, particularly for a Boxed Warning and REMS product is high risk; (e) FDA’s enforcement reach is long; and (f) the agency can move quickly when it wants.
We continue to recommend that companies train all personnel that make public appearances on behalf of the company, regardless of the venue, about the FDA rules on product promotion. Whether such training is done internally or externally is less important than it be done. In addition, company standard operating procedures should reflect that FDA’s enforcement authority extends to oral statements and investor-related messaging if there are product discussions.
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