How to Create a Pharma Website That Will Get You a Warning Letter

How to Create a Pharma Website That Will Get You a Warning Letter

November 7th, 2011 // 1:37 pm @

Given the increased scrutiny the FDA is applying toward websites devoted to individual prescription drugs, it may behoove the people who design these sites to include some basic info. Such as? Well, there are always tidbits about safety and efficacy. A helpful rule of thumb, for instance, is to ensure safety info is not minimized or absent. And using hyperbole to describe the drug is not a good idea.

Unfortunately for Otsuka Pharmaceutical, no one was paying attention. In an untitled letter sent by the FDA last month, the drugmaker was chastised for overlooking these fundamental principles of creating a drug website in the modern era. And, of course, the agency says the site for Bulsufex, an injectable cancer treatment, is misleading.

For instance, the site omits important material risk information concerning usage in children. None of the adverse event data reported for pediatric patients showed up and some of these side effects were associated with some rather large numbers – vomiting (100 percent), nausea (83 percent) and stomatitis (79 percent). But, you know, why scare anyone?

Moreover, Otsuka forgot to note that patients should be given anti-nausea meds prior to treatment with Bulsufex as well as remain on a fixed schedule for the duration of treatment. “This treatment recommendation is particularly relevant in light of the fact that nausea and vomiting occurred in 98 percent and 95 percent of patients, respectively, in the pivotal clinical trial,” the FDA writes.

The agency also chastises the drugmaker for throwing around such adjectives as predictable, controllable and consistent to describe how easy and effective it can be to use its med. An example – a predictable pharmacokinetic profile. But the FDA maintains the language is misleading because the claims cannot be substantiated. Pretty adjectives, but no evidence to back them up. Oh yes, Otsuka is also scolded for suggesting that administration of Busulfex is “straightforward,” as claimed (here is the FDA letter).

The upshot? The web site is down (look here). Meanwhile, Otsuka may want to read the dummies guide.

Source: Pharmalot


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