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Health Reform and FOB’s: From Debate to Done in Thirty Days

On Tuesday morning, October 13, the Senate Finance Committee is scheduled to vote on its version of health reform legislation. This is ground zero in a contest of political will and national priorities that began over 65 years ago. This is big…a tidal wave of change coming to the US health care system.

The Finance Committee bill, once passed, will be melded with the version passed in the Senate Health, Education, Labor and Pension (HELP) Committee. Although it’s a small detail in the massive health reform bill, the future of follow-on biologics (FOB’s) depends on what comes next.

Since early July, FDA Matters has expressed its political admiration for Representative Anna Eshoo’s bi-partisan success in garnering more than 140 cosponsors for her bill. I have never seen a committee chairman face the overwhelming odds this presented to Representative Henry Waxman.

Yet, I reminded my readers that Chairman Waxman has a long-history of “not having the votes” and winning anyway. I repeated this observation in August and again in September. This was confirmed, indirectly, by Waxman in a speech he gave about two weeks ago when he told his audience that he hadn’t given up on his version of FOB legislation. He asked them to keep working to get his bill passed.

There are at least four opportunities for the very similar House and Senate FOB provisions to be altered to favor Chairman Waxman’s position:

  • when the two Senate committees merge their health reform bills,
  • when the three House committees merge their bills,
  • when the bill goes to the Senate floor and can be amended, and
  • during the House-Senate conference to reconcile differences between versions passed by each body.

Three of these opportunities will take place behind closed doors where anything can happen. You don’t need to “have the votes” to prevail….only to be in the room when the decisions are made. Chairman Waxman will be in Speaker Nancy Pelosi’s office when the deal is cut on the House side. His ally, Senator Charles Schumer, will be in Majority Leader Reid’s office when the Senate bill is agreed upon. Both Waxman and Schumer will be on the House-Senate conference committee.

I no longer think it will happen this way. This multi-step process is a recipe for legislation to be bogged down until next year when health reform and FOB’s will die an agonizing election-year death.

To avoid those delays, the Senate bill will be the Finance Committee bill with:

  • some provisions from the HELP committee version,
  • some provisions necessary for Reid to get to 60 votes in the Senate to avoid a filibuster, and
  • a few provisions that are high priorities for the House (other than a public plan).

The President will then endorse the Senate bill. Assuming Reid has negotiated carefully and counted correctly, the agreed-upon bill will be moved quickly to the Senate floor. The 60 Senators will have agreed not to offer amendments on the Senate floor (allowing one amendment will allow hundreds).

As soon as the Senate-passed bill reaches the House, the Speaker will schedule an “up or down” vote. The President will help her keep the Democratic majority together. There will be no House-Senate conference.

The pending “behind closed doors” Senate negotiations may be the only time further changes will be made. Afterward, Members of Congress will be able to blame Reid and Pelosi that they weren’t allowed to offer amendments favored by whatever constituents and health care stakeholders they were trying to help.

The bio-pharma and generic industries probably have no more than two to three weeks to persuade the Senate negotiators to take their side on data exclusivity and other FOB issues. There may be no second chance.

We are going to go from “debate to done” in thirty days.


My prior columns on follow-on biologics are at:

Fall Scorecard for Follow-on Biologics,
September 11, 2009

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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