FDA Blasts Teva for Overblown Marketing Materials

FDA Blasts Teva for Overblown Marketing Materials

April 23rd, 2013 // 1:02 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

Most pharmaceutical companies are aware of all of the requirements for putting together marketing materials for their drugs. This includes submitting forms that spell out all of the marketing messages that are to be given.

Teva Pharmaceuticals was hit hard by FDA this month for putting together a doctor’s handout for its Clozapine schizophrenia drug that minimized risks and made several claims without evidence.

FDA sent the firm an April 8 untitled letter. FDA blased Teva because the handout gave the implication that Clozapine has shown major efficacy in treating for out of five of the major symptoms – positive, excitement, cognitive and depression or anxiety and also various symptoms of excitement.

When Teva did this, it was relying on only one study. This was a retrospective clinical trial that took data from analysis that had been published previously. The Office of Prescription Drug Promotion at FDA noted that one study like this is not enough to establish strong evidence or clinical experience to make these types of marketing claims.

Risk data also was very limited, according to the letter. Teva did not mention that Clozapine is not desirable for patients that have hypersensitivity to Clozapine or any of its related components. The handout also did not provide information about risks, such as hyperglycemia/fever and QT interval prolongation.

Also, the article used pictures and graphics to make several efficacy claims, and big, bold fonts with lots of white space. But the risk information was put in small font in a block of text on the back. If there is such a stark contrast between marketing and risk information, FDA is going to get involved.

Overall, FDA took Teva to task for downplaying serious risk information and suggesting that Clozapine is safer than has been shown in clinical trials.

Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:

Updated Daily – Read our latest FDA, cGMP Compliance News

Subscribe Now

Featured Partner