Published Online: Thursday, February 1, 2007

The generic drug industry-supported legislation that directs the FDA to develop new ground rules for the approval of generic biotech products has climbed to the top of the congressional agenda this year in both the House and the Senate. Legislation was introduced in both chambers late last year by leading Democrats, including California Congressman Henry Waxman and New York Sens Charles Schumer and Hillary Clinton. Although that bill languished in committee under the Republican leadership, the plan is expected to come roaring back to life this year with Democrats now in control of both houses of Congress.

Because development of a truly equivalent generic biotech product is more difficult and complicated than the production of traditional generic drugs, enactment of the industry- backed legislation would not necessarily trigger an immediate upsurge in the availability of low-cost versions of biotechnology medicines. Instead, it would permit the FDA to determine whether generic manufacturers need to repeat expensive human clinical trials in order to document the equivalency of their products.

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