The FDA’s Division of Drug Marketing, Advertising and Communications got off to a busy start in January.
The agency released a new batch of enforcement letters, bringing its tally for the month to nine. All were “untitled letters,” somewhat less serious than “warning letters.”
The most recent posted, issued on the 27th, said patient videos and a website for Lilly and United Therapeutics’ Adcirca were false and misleading – the site because it omitted risks associated with the pulmonary arterial hypertension drug and the patient videos because they overstated efficacy. Another letter, not yet released, went out to Takeda on the 28th for Rozerem promotions, and a letter was issued on Aricept marketing yesterday.
Other letters went to: Sanofi-Aventis, for a BenzaClin patient brochure; Meda Pharmaceuticals, for a waiting room sign touting Astelin Nasal Spray; and Novalar Pharmaceuticals, for an OraVerse patient brochure. Earlier in the month, the agency issued letters to: Baumann Cosmetic and Research Institute, for promotion of Medicis and Ipsen’s as-yet unapproved Dysport wrinkle filler; Bracco Diagnostics, for a website promoting its Isovue; GE Healthcare, for a website promoting its Visipaque Injection; and Lilly, for consumer print and journal ads promoting Cymbalta for fibromyalgia.
In 2009, DDMAC issued 41 enforcement letters, including 28 untitled letters and 13 warning letters. That’s a big jump over 2008’s 21 letters, including 10 untitled letters and 11 warning letters.