Published Online: Sunday, April 1, 2007

Efforts by generic drug industry leaders to pressure the FDA into establishing a clear-cut abbreviated approval process for generic versions of biologic drugs drew mixed support on Capitol Hill as the Senate Health Committee launched a new round of hearings on the issue. In a statement kicking off the hearings, Committee Chairman Edward Kennedy (D, Mass) said that Congress has "a responsibility to expand the horizons of medical science." Legislatively, "our goal...should be to enable companies to invest in new medical breakthroughs, while doing all we can to cut costs for patients and protect safety."

Unlike advocates of pending biodrug approval legislation, however, Sen Kennedy appears to be leaning toward a more conservative path that critics say would sacrifice approval speed for "excess" safety. Specifically, he favors the approach for generic biodrug approvals used in Europe—a system that permits cheaper generic versions of insulin and other biologics to reach the market, but only after their sponsors conduct lengthy and expensive clinical trials.

Critics of that approach, including sponsors of the pending Senate legislation and generic drug industry leaders in the United States, fear that requiring such clinical testing would have a chilling effect on the development of generic biodrugs without providing any corresponding increase in safety.

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