Here's a post from In the Pipeline lamenting the President's new budget submission. It seems the White House is now backing language that would limit exclusivity on biologics (biosimilars) to seven years instead of the previously agreed upon twelve. Of course, if you look through posts on this blog and other sites - one can't really be sure what the data exclusivity agreement was the first time around. At least three groups of Congressmen (and women) have sent letters to the FDA describing market or data (which is it?) exclusivity periods ranging from 4 to 12 years. So the budget submission should be no big shocker in my view.
Like most things in the realm of politics, they change. It just opens a new season of bartering. Now, the industry can still lobby for the longer exclusivity periods but might also open up other territory like pricing or R&D credits/grants or patent protection revisions as chips to bargain with in exchange for concessions on exclusivity terms. Or they can just engage in vigorous lobbying for the exclusivity terms they want and spend their money with the factions supporting their point of view -- i.e. engage in the usual Washington politics?
Posted by Bruce Lehr Feb 17th 2011.