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Follow-on Biologics and the Dance of Legislation

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.

Mr. Waxman is proposing generics-friendly legislation (HR 1427). As the committee chair, he is well-positioned. Plus, he has 12 co-sponsors, including the chairman (Pallone) and ranking minority member (Deal) of the health subcommittee. Usually, this is enough to win outright or with only modest compromises.

But Waxman is in a stand-off with committee member and fellow Democrat, Representative Anna Eshoo. Her bill (HR 1548) is considered friendly to the biotechnology industry. She is joined by the ranking minority member of the full committee (Barton). Together they have amassed an extraordinary 108 bi-partisan cosponsors. This is one-fourth of the House’s total membership!

Representative Eshoo has the momentum, having added 50 co-sponsors since April 15, compared to 2 for Representative Waxman. Further, Waxman is under pressure to include follow-on biologics in the health reform bill mark-up, duplicating the legislative situation in the Senate.

Chairman Waxman is reportedly resisting any effort to move legislation on follow-on biologics. He lacks the votes to prevail and must stall for enough time and leverage to work his political magic.

On the Senate side, Chairman Kennedy is sticking with a two-year old bipartisan compromise, which is much closer to the Eshoo position than to Waxman. He has put the FOB bill into the health reform legislation being considered by the Senate HELP Committee this month.

Enter the generic drug industry, Senator Schumer, and the AARP…and the Senate plot thickens.

The generic drug industry chose not to make a deal in 2008—in the reasonable belief they would do better with a Democratic Congress and President. They are hoping to retrieve the situation with Senator Schumer, who has introduced the Waxman bill in the Senate (S 726). His bill (and seven bi-partisan co-sponsors) assures that the Kennedy bill will not move forward without visible dissent. Meantime, the AARP reportedly told Senator Kennedy’s staff that they will not support the HELP committee’s health reform bill unless the FOB portion is modified to be more like the Waxman-Schumer bill.

The most contentious issue in both Houses is the length of time during which innovator companies can prevent a FOB from being approved based on the innovator’s research. This so-called “data exclusivity” should not be confused with the far-more-desirable “market exclusivity,” which is not part of any bill.

In round numbers, Waxman is proposing 5 years of data exclusivity, Eshoo 14 years and Kennedy 12 years. There is no objectively correct number—just differing beliefs in how much time is needed to make sure that the growth of an FOB market doesn’t reduce incentives for innovation. An average of the three numbers suggests a compromise of about 10 years.

Enter the Federal Trade Commission and the White House…and the whole plot thickens further.

The FTC analysis—featured at a House hearing and widely covered in the media—contends that no data exclusivity is needed to preserve incentives for innovation. Now there are four numbers and the average is 7.5 years. Last week, the White House jumped in to officially advocate for 7 years.

The endgame on data exclusivity is becoming clear. It will be between those who will accept seven years and those who will insist on at least 10 years. Even knowing this, it is hard to tell whether and when the logjams will be broken in the House and Senate.

The unfolding politics of FOBs are going to make for a fun summer and may creep into football season! Someone is likely to score a touchdown (or learn to dance the tango)!


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