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Focus on Regulation

CEO Media Statements Draw Additional Scrutiny

The Food and Drug Administration (FDA) has issued a second enforcement letter regarding a pharmaceutical company executive’s statements on television. On March 12, 2015, the Advertising and Promotional Labeling Branch (APLB) of the Center for Biologics Evaluation and Research (CBER) issued an Untitled Letter to Protein Sciences Corporation for a video interview posted to the company’s website. In an interview aired on a LifeTime morning show called “The Balancing Act”, the company’s Chief Executive Officer (CEO), Dr. Manon Cox, spoke about the company’s drug, Flublok (Influenza Vaccine).

Dr. Cox stated that Protein Sciences “is able to put three times more protein in there, so it is also a high dose vaccine. More protein means your body will form more antibodies that will help you fight the flu.” FDA found this claim misleading because it implied that the higher antigen content results in greater flu protection, and concluded it was unsubstantiated. According to the agency, it had previously advised the company that the claim was misleading. FDA also noted that the video presented multiple efficacy claims for the drug, such as “helps you fight the flu,” but omitted important safety information.

When FDA issued its first enforcement letter in November 2013 to a company for an executive’s statements to the media, we were cautiously optimistic that it would be a rare occurrence. Now, with a second letter, this seems more like a trend. As a result, we recommend that companies ensure that all media statements and talking points are reviewed by promotional review committees (PRCs) in advance.

Pursuant to the Untitled Letter, the Protein Sciences interview was removed from the company’s website, though it is still available on The Balancing Act’s website here.

The Protein Sciences Untitled Letter is available here.