When FDA stakeholders discuss health reform, they usually focus on finance rather than regulation. They have strong interests in Medicaid rebates, formularies, adequate reimbursement to support innovation, and who is for/against the President’s plan. None of these finance issues affects FDA, although they will certainly have an impact on FDA-regulated industries.

Less often discussed in this larger debate is that some health reform bills include provisions that would alter or expand FDA’s responsibilities. The best known and most far-reaching provision would create a regulatory pathway for follow-on biologics (FOB). The fate of FOB, as well as other FDA provisions in the House Energy and Commerce and Senate HELP bills, will be determined by how health reform unfolds this fall. (more…)

One of the reigning champions of political chess, Representative Henry Waxman, has found himself in an endgame on follow-on biologics (FOB). His three decades of success have been built on extraordinary mastery of Congressional procedure, artful compromise and strategic alliances. His defeat seems unavoidable, but no one should assume that he can’t yet win or draw this game. (more…)

Political scientists love to watch the dance of legislation. FDA watchers are eager to see how thorny agency issues will be decided by Congress. Both will be fascinated by the latest moves and turns in Congressional consideration of legislation on follow-on biologics (FOB).

I can’t recollect an instance in which a House chairman faced such massive bipartisan opposition. But never count House Energy and Commerce (E&C) Committee Chairman Henry Waxman out. He has made a career of not having enough votes… and winning, anyway. (more…)

Since the debate began several years ago, the policy and politics of follow-on biologics (FOB) have been driven by assumptions and projections of the anticipated market. In my opinion, there has been a lot of fuzzy thinking about what type of companies will be players and how they will position themselves. The Federal Trade Commission report, released last week, is just the latest illustration. (more…)