On Friday, I had the opportunity to provide some thoughts to Matthew Perrone of the Associated Press in relation to an article he was writing about the recent "early communication" from the FDA regardin GlaxoSmithKline's Over-the-Counter weight loss product alli.
By way of background, in August, the FDA issued an "Early Communication About an Ongoing Safety Review" for alli due to 32 reports of adverse events associated with the liver over a ten year period – or an average of 3 cases per year. (It should be noted that orlistat, markted OTC as alli, is also marketed under prescription status by Roche.) This included a posting about the "early communication" and a press release as well.
Early communication raise a sort of alert about a product based on some reports. Looking past the substance of the "early communication" – the fact that there have been at least four such communications this year leads to questions of another nature. What the heck is an "early communication"?
According to Perrone's Associated Press article, the practice began in 2007 and has been aimed at a number of products and the FDA began doing them in response to criticism regarding their slow response to the issues surrounding Vytorin. And because they are relatively new, companies are caught off guard when one is issued, particularly because, as Matthew Perrone points out, the FDA has stated that they do not give companies advance notice of the issuance of an "early communication". What then should companies do to prepare? Here are a couple of thoughts:
- Know Your Warts - Every medicine has its warts. It is important to know them and follow them. That means knowing what your adverse event profile is and watching it closely. When you see a trend, even one that is miniscule – if it represents a potentially serious problem, add a chapter to your communications scenario playbook about the potential emergence of the issue. If you don't have a scenario playbook, make one. Step away from the Kool Aid.
- Monitor in Real Time – This going to vary by regulatory culture, but just as Google can track flu trends and anticipate an outbreak, you can follow and assess what people are saying about your product in the ether. Afraid you might find an adverse event? Fine. Continue with the blinders. But then don't be surprised when you are surprised by what people have been saying. Don't wait for an early communication to impact sales. Sales impact means the horse has left the barn. Get your information early – as it happens.
- Key Words – As you identify your warts, identify the key search terms that people would use to explore the issue on the Internet and be ready to purchase those terms so that you can ensure that the information you have ready (in your scenario playbook) comes up in paid search links back to information on the topic that you can provide. Every minute of every day that goes by that you haven't done that once a crisis unloads, you lose valuable ground on the Internet.
It is safe to say that with the public health-minded roots of the FDA's new leadership, the prospect of an increased number of "early communications" is likely to continue. That is despite the fact that they are not an evidence-based intervention and the agency has not assessed whether they are discouraging use of a product by people who may have need for it, but as a result of the issuance of the communication, now steer away from it. For example, are there some obese people now afraid to use an approved product who would otherwise have benfitted from its use, because of uninvestigated cases of an adverse event over a period of a decade in only 32 people? (By the way, according to the Perrone article, the FDA failed to mention that only 2 of the 32 reports involved the GSK product alli.) What is the risk-benefit ratio here? We don't know – and most certainly, the FDA doesn't know.