FDA warned Abbott about a patient testimonial DVD for its HIV drug Kaletra, starring Earvin “Magic” Johnson.
The DVD, I Know What’s Important, minimizes the risks, overstates efficacy and includes unsubstantiated claims, DDMAC said in a warning letter dated July 14.
At the beginning of the DVD, Johnson answers questions in an interview-style format, although “the only risk information included during the interview are a brief acknowledgement by Johnson that he experiences ‘fatigue sometimes,’” with other risk information superimposed in text, according to the letter.
DDMAC contends that the interview portion omits “any discussion of serious risks,” and relegates that information to the end of the program, “where it is unlikely to draw the viewer’s attention, and is displayed as a running telescript.”
Additionally, DDMAC took issue with several statements made by Johnson during the interview that overstated the efficacy of Kaletra: “While these statements may be an accurate reflection of Magic Johnson’s own experience…this promotional testimonial suggests that Kaletra has been shown to allow all or most antiretroviral treatment-experienced individuals…to live a ‘normal life’…for five or more years.” Evidence is lacking for that claim, the letter said. The DVD also featured outdated product labeling.
DDMAC’s warning letter to Abbott follows an untitled letter on the subject of Kaletra promotion in 2004 – that letter questioned a print ad and poster that overstated effectiveness and omitted risk information.
In September 2008, Shire was warned over a patient testimonial video featuring celebrity Ty Pennington, after he discussed his experience with Adderall XR – and inadvertently expanded the drug’s indication.
In other FDA correspondence news, ViroPharma, a Pennsylvania-based biotech, received an untitled letter in June regarding branded panels and sales aids for Cinryze, a product indicated for a rare type of swelling called hereditary angioedema. Those materials were deemed “false or misleading because they present efficacy claims for Cinryze but fail to reveal, and they minimize, material facts; they make unsubstantiated comparative claims; and they overstate the efficacy of Cinryze,” according to a letter signed by Robert Sausville, director, division of case management at the Office of Compliance and Biologics Quality. That division is part of the Center for Biologics Evaluation and Research.
