FDA warns Flublok maker of overreaching claims
The US Food and Drug Administration (FDA) in a recent letter to the maker of Flublok, the insect-cell-based influenza vaccine, warned the company of overstating the vaccine's effectiveness and omitting mention of potential risks in promotional materials.
In the letter, dated Mar 12 but just recently made public, the FDA said that Protein Sciences Corporation's video, "Watch Us on Lifetime—the Balancing Act," is in violation of the Federal Food, Drug, and Cosmetic Act and the FDA's implementing regulations.
The FDA took issue with the claim of President and CEO Manon Cox, PhD, MBA, in the video that Flublok "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."
The FDA told Protein Sciences, "This claim misleadingly implies that the higher antigen content of Flublok translates into greater protection. Currently, there is only one licensed high-dose influenza vaccine . . . . FDA is unaware of any adequate and well-controlled clinical trials that substantiate this claim for your product."
The agency also decried the lack of discussion of risks in the video.
"Specifically, the video presents multiple efficacy claims for Flublok, such as 'helps you fight the flu,' but fails to present any important safety information from the PI [prescribing information]."
The FDA gave Protein Sciences 10 business days to respond to the letter.
http://www.cidrap.umn.edu/news-perspective/2015/04/flu-scan-apr-17-2015
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