MedImmune has reportedly pulled the plug on a pamphlet promoting its FluMist nasal spray after the US Food and Drug Administration said it was misleading and failed to provide adequate information on how to use the product, as well as the risks associated with its use.
A spokeswoman for the company told Reuters that the firm had stopped using the flyer in question and was “actively working” with the FDA over the letter.
The warning letter, which was dated 21 June but posted on the agency’s website yesterday, said that the flyer simply stated: “There are risks associated with all vaccines, including FluMist. Like any vaccine, FluMist does not protect 100% of individuals vaccinated.” The agency said more specific information was needed to qualify the effectiveness claim. In addition, it said that the omission of risk information and failure to provide adequate directions for use misbranded the product. “You should revise this flyer to include appropriate risk information,” the agency said.
In addition, the FDA said that the flyer incorrectly states the FluMist indication for “…healthy adults, 19-49 years of age” when the actual prescribing information for the product states: “FluMist is indicated for… healthy adults, 18-49 years of age.”
MedImmune had ten working days from the date of the letter to stop dissemination of the material in question and submit a written response to the FDA stating its plan for discontinuing the use of the flyer. The FDA said that because it considered the violations serious, the firm would also have to submit a plan of action to “disseminate truthful, non-misleading, and complete information to the audience(s) that received the violative promotional material.”