The use of language is a subtle art. Ask any regulator. And the regulators at the FDA have determined that Novartis was a bit too subtle, perhaps, in trying to promote its Fluvirin vaccine for the flu. The agency recently issued a warning letter that chastised the drugmaker for distributing a sales aid and print advertisement that were deemed misleading.
Specifically, the promotional materials incorrectly characterized a published recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and implied the Novartis vaccine can be used in all age ranges covered by the ACIP recommendations, according to the FDA letter, which was issued on February 4.
For the current flu season, the ACIP recommended annual vaccination including infants who are six months and older. As the FDA noted, this expanded earlier recommendations for annual vaccination of all adults aged 19 to 49 years old and was supported by evidence that an annual flu shot is safe and effective for prevention in all age groups.
But the Novartis promotional material says: "The ACIP’s new universal flu vaccination recommendation includes all persons 4 years of age and older." Contrast that with the prescribing info approved by the FDA: "Fluvirin is...indicated for active immunization of persons four years...and older...(and) is not indicated for children less than four years (old) because there is evidence of diminished immune response in this age group."
In other words, the promotional material subtly suggested an expanded recommendation. "Promotional materials are misleading if they use a quote or paraphrase out of context to convey a false or misleading idea. Your materials misrepresent the ACIP recommendation and imply that Fluvirin meets the recommendation when, in fact, Fluvirin has not been demonstrated to be safe and effective for the entire population included in the recommendation (ie, six months and older)," the FDA wrote in the letter.
Perhaps this use of language was inadvertent. There is often a tendency, after all, to massage wording to spice it up or easier to digest. But this one example illustrates the wisdom in 'sticking to the knitting,' and not taking liberties with prescribing language that, no doubt, Novartis previously spent countless hours and dollars reviewing with the agency.