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Senate panel gives 12-year exclusivity to biotech drugs

Christine McConville Boston Herald 07/14/2009 20:45
Senate panel gives 12-year exclusivity to biotech drugs - USA - biotechnology - law - Business - health care


Biotechnology companies are cheering a U.S. Senate committee decision that would give them 12 years before they have to share their drug data with competitors.



“Last night’s vote is a victory for the patients of today and tomorrow,” Biotechnology Industry Organization President and CEO Jim Greenwood said this morning.

Late Monday, the Senate Committee on Health, Education, Labor and Pensions approved a 12-year data exclusivity clause. That means biotechnology companies don’t have to share their drug-making data with generic drug manufacturers until the high-cost products have been on the market for 12 years.

The measure passed 16 to 7, despite a strong push by the Obama administration for a seven-year exclusivity limit.

Sen. Edward M. Kennedy, a Massachusetts Democrat and the chairman of the HELP committee, voted by proxy to support the 12-year limit.

Biotech companies had pushed for a longer period of data exclusivity because, they say, it can take 15 years and as much as $1 billion to bring a new medicine to patients. They say data exclusivity to recoup money they’ve invested to make the product.


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