Tuesday, June 24, 2008

Wacky World of Generics: Pajama Party Edition

Have you ever had one of those dreams where you show up to the office in your pajamas? Well, it can be argued that the generics industry has been doing just that lately and it’s been working well for them.

The reason for the casual dress is FDA’s current policy on 180-day exclusivity for first-to-file generics. The agency awards the much sought-after exclusivity people to the first-to-file generic applicant, even if the ANDA isn’t terribly professional looking. The application doesn’t have to be all showered and combed to be eligible for those six very profitable months when the sponsor is the only generic on the market.

Due in part to this policy, many applications have been coming into FDA’s Office of Generic Drugs quite early, and it’s starting to look like the kind of place where people walk around in purple slippers. (We are pleased with this analogy because generic firms did in fact used to have sleepovers at FDA, camping outside the office in order to be first-to-file. The agency solved the problem by saying that everyone who submitted an application on the same day had to share. How to solve the problem of messy applications seems a bit more complicated.)

A report by the HHS Inspector General details the problems that FDA has been having trying to keep pace with the flood of submissions. As a result of the deluge, the agency has failed to meet the review deadline for nearly half of the applications it received, and has approved only 4 percent the applications on the initial cycle.

FDA, though, does not seem enthusiastic about the advice that the IG report offers as a fix, which would involve reprioritizing the order of reviews to focus on applications that were closest to approval. Instead, the agency is beefing up its review staff, and new legislative provisions that trigger the forfeiture of generic exclusivity may encourage better, slower application development (subscribers to “The Pink Sheet” can read the details).

But in the meantime, the document room in the Office of Generic Drugs isn’t going to be winning any fashion awards.

--M. Nielsen Hobbs

(Pajama image courtesy of Flickr user Iroma Baby via a creative commons license.)

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