Waxman urges Obama to bust open biogeneric pathway

After a long campaign to get Congress to adopt an aggressive biogenerics bill, Congressman Henry Waxman is suggesting to President Obama that the FDA should be urged to get started on approving biosimilars even before a new law passes.

"I urge the administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics," said Waxman, chairman of the Energy and Commerce Committee, in a letter to the president. Waxman also reminded Obama of his pledge to bring down the cost of biologics, which has helped fuel healthcare costs.

Waxman has been pushing a bill that provides a five-year window of market exclusivity for biologics, something the biotech industry views with the kind of alarm a farmer feels when he sees a tornado heading for the barn. But there are a lot of numbers in play on the Hill. A competing bill offers 14 years of exclusivity and the president's budget proposal for 2010 pencils in a seven-year period.

- read the report from the AP

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