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Fall Scorecard for Follow-on Biologics

The creation of a regulatory pathway for follow-on biologics (FOB) has become a favorite topic of FDA Matters. The substance of the legislation is important and the politics are fascinating. It should get even better this fall.

The House Energy and Commerce Committee and the Senate HELP Committee have both put FOB provisions into their health care reform bills. If the two FOB bills were to be considered in a House-Senate conference on health reform, it would not be hard for conferees to agree on a final version. Yet, for reasons given below, FOB legislation may not become law this year and the current House and Senate provisions may be changed before (or during) conference.

House status. House Energy and Commerce Committee Chairman Henry Waxman has proposed generics-friendly legislation (HR 1427). Fellow Democrat and committee member, Representative Anna Eshoo, has proposed a competing, bio-tech friendly bill (HR 1548). The two have been in a stand-off since introducing their bills in March of this year. With help from Representative Barton, the ranking minority member of the full committee, Eshoo’s bill has amassed 142 bi-partisan co-sponsors, about 1/3 of the membership of the full House and far more than the Waxman bill.

An Eshoo amendment was successful during the July health reform mark-up, so FOB is now part of the House health reform package. Her amendment was similar to her original bill, with some changes to make it closer to the Senate compromise bill.

Although the Eshoo amendment has the upper hand, Chairman Waxman still has options. It is possible that FOB’s will not emerge from the melding of the three different House committee versions of health reform. House leadership may help him keep FOB out of the final legislation when it is considered by the House. Perhaps there will be changes in the Senate bill, allowing more room for compromises in the House-Senate conference committee.

Senate status. On the Senate side, the HELP committee put a two-year old bipartisan FOB compromise into its health reform bill. As noted, it is much closer to the Eshoo position than to Waxman. However, the HELP-passed version of FOB may not be the final word in the Senate.

Senator Schumer has introduced the Waxman bill in the Senate (S 726). His bill (and its seven bi-partisan co-sponsors) assures that the HELP bill will not move forward without visible dissent on FOB. The HELP version is also subject to modification when the Senate Finance and Senate HELP committees merge their two versions of health reform.

The health reform factor. Without enactment of health reform, the Eshoo bill and the Senate compromise bill may be dead for this year and, maybe, for this Congress. Short of an equally-compelling, must-pass health vehicle, Chairman Waxman, as chairman, is unlikely to give Representative Eshoo a second chance to offer her FOB amendment. Without passage of health reform, any future House action on FOB is likely to require Waxman’s input.

The Senate situation is likely to be similar. If FOB is not in the final health reform bill, then it will be difficult to sustain the Senate FOB compromise version, especially without Senator Ted Kennedy to advocate for it.

The fate of FOB also becomes uncertain if the health reform bills are substantially narrowed in scope. For example, if the final legislation focuses on insurance reform, then FOB might not be in it.

FOB: the substance is important and the politics are fascinating. Stay tuned!


Prior columns on follow-on biologics:

Health Reform and Follow-on Biologics September 6th, 2009

The Best Little Chess Game in Town August 3rd, 2009

Follow-on Biologics and the Dance of Legislation July 5th, 2009

The Follow-on Biologics Market June 23rd, 2009

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