The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) issued an untitled letter to Cephalon, Inc. on June 21 after reviewing the company's HCP website for the injectible drug Trisenox, indicated for the treatment of acute promyelocytic leukemia (APL). The letter, issued to Franklin Vairinhos, PhD, director of regulatory affairs at Cephalon, indicated that the website “broadens the indication for Trisenox, minimizes and omits risks associated with the use of Trisenox, presents misleading and unsubstantiated claims, and overstates the efficacy of the drug,” misbranding the drug in violation of the Federal Food, Drug and Cosmetic Act.
DDMAC highlighted misleading content found on the Trisenox website as information that broadened the drug's indication (“Trisenox: Standard of Care in Relapsed and Refractory APL”), minimized the risk of taking the drug (“Trisenox works with minimal chemotherapy-related side effects”), and overstated the drug's efficacy (“Trisenox delivered both high rates of remission and survival in this type of leukemia, giving hope to APL patients who have relapsed or who did not respond to their initial therapy”), to give a few examples. DDMAC requested that Cephalon immediately cease the dissemination of violative promotional materials for Trisenox and submit a response to the untitled letter by July 5 of this year.
In an email to MM&M, Candace Steele, a spokesperson for Cephalon, said: “Cephalon strives to be compliant with all federal, state and local regulations and we take our responsibility of sharing fair, accurate and balanced information very seriously… With respect to the letter, the Company has already initiated communication with FDA to ensure full understanding of its content and is taking steps to prepare our response to FDA that will be delivered on or before July 5, 2011.”
“In the meantime, the Trisenox website has been registered inactive, with a re-direct to our corporate site,” Steele wrote. “Beyond this measure, Cephalon has also initiated a comprehensive review of all Trisenox promotional material to ensure consistency and conformity to the content of the letter. Additionally, all Cephalon Trisenox sales representatives have been notified and instructed to cease using or sharing certain Trisenox promotional materials at this time, pending further review.”