Wednesday, July 22, 2009

Survey Says More FOB Negotiation Needed

Brands aren't going to get exactly what they want on follow-on biologics, not if the predictive powers of In Vivo Blog readers have anything to say about it. An FOB pathway with the brand-favored 12 years of data exclusivity cleared the Senate Health Committee, and seems poised to be added to the House bill, if the Energy and Commerce Committee mark-up ever resumes (it actually might on Wednesday). Still, you – at least those of you who took our poll – thought that the exclusivity number would eventually come down. We'll spare you just how unscientific this survey was, but while 12 years got the most votes of any of the specific categories (30%), more people overall though that exclusivity would be less than 10 years (36%).

Clearly, then, there's a lot more negotiating that needs to be done.

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