FDA To Cephalon: How Not To Build A Website

FDA To Cephalon: How Not To Build A Website

June 28th, 2011 // 12:52 pm @ jmpickett

With concerns about social media front and center, drugmakers can clearly use some guidance when it comes to creating a product web site. Then again, a degree of common sense should already be in place, yes? Cephalon, however, committed a few avoidable blunders with a web site for Trisenox, which was approved to treat acute promyelocytic leukemia.

An FDA warning letter dated June 21 notes that in the healthcare professional website for Trisenox, Cephalon overstated the case for its drug in big, bold letters in a prominent location at the top of the web pages. The agency found the claims misleading, “because they suggest that Trisenox is approved to treat patients with any kind of relapsed or refractory APL when this is not the case.” There are, in fact, some important limitations.

And “failure to include the important limitations to the Trisenox indication misleadingly suggests that the drug is useful for a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience,” the FDA notes. The full indication statement is included in small type on the bottom of each web page, beneath the list of references. “However, this presentation does not mitigate the misleading implication created by the bolded headers.”

Beyond broadening indications, Cephalon also minimized risk with web pages that “prominently present efficacy claims and presentations in large, bold, and colorful font and graphics, on the top portion of each page. In contrast, information about the serious and potentially fatal risks associated with Trisenox, including Boxed Warnings, are relegated to the bottom of the pages, after the list of references, and written in small gray font and in single-spaced paragraph format.”

The problem is that the important risk info is not presented – and, therefore, is not emphasized – in the same way as the effectiveness claims. “The overall effect of this presentation greatly undermines the communication of important risk information, minimizes the risks associated with Trisenox, and misleadingly suggests that the drug is safer than has been demonstrated,” the FDA writes in its letter (you can read it here).

The letter goes on to complain that various claims are unsubstantiated or misleading, or that additional risk information is omitted. In other words, at issue is both style and substance. In many ways, the FDA missive could have been addressing a direct-to-consumer ad from years past in print or on television. But that was then and this is now.

Just the same, one would think Cephalon should know better than to play up the good things and play down – in tiny font – the not-so-good things, and to do so in an incomplete way. But some people need more guidance than others.