Shire got slapped with a letter from FDA's Division of Drug Marketing, Advertising, and Communications last week for improper promotional material associated with the renal disease treatment Fosrenol.
In question is a notebook and medical exam light case distributed to physicians at a renal disease conference. FDA disapproved of the phrases "First line," "For reductions that last," and "Calcium-Free," all of which were included in the promo material. The agency stated in its letter: "Reminder pieces may not include, among other things, representations or suggestions concerning effectiveness or patient population."
FDA defines reminder labeling as any material that includes the name of the drug, but does not promote it through dosage recommendations, indications, or other uses. Promo pieces considered reminder labeling do not have to include risk information or drug indication in accordance with 21 CFR 201.100(f).
Shire's Director of Communications Matt Cabrey told Pharm Exec on Tuesday that they responded to FDA and are fully complying with the Feds. "This material was not intended initially to be an item that was detailed by representatives in the field at physicians offices," Cabrey said. "We absolutely agree with FDA's assessment, and we are committed to following FDA guidelines so that we are in compliance with regulatory requirements."
He characterized this situation as a review process oversight, and said that Shire now has a much clearer understanding of the red flags it must look for prior to producing promotional material.
"The rules are arcane, but FDA says a manufacturer can run 'reminder' ads with just name of product, as long as there's no suggestion of the benefit," said Mel Sokotch, former ad exec at Foote Cone & Belding and Grey Advertising. "Pfizer got into trouble with a reminder ad for Viagra that featured a middle-aged man [telling his wife] that the guy she married 'way back when' is back." Although the advertisement only mentioned Viagra, the commentary suggested that Viagra helped him get his libido back.
"The Shire case is far subtler," Sokotch said. "FDA obviously felt that the combination of logo and copy amounted to a communication of the med's benefit, and the benefit must always be balanced with the warnings."