Tuesday, July 14, 2009

Senate panel gives 12-year exclusivity to biotech drugs

The Senate Committee on Health, Education, Labor and Pensions approved a 12-year data exclusivity clause for Bitoech companies before they have to share their drug-making data with generic drug manufacturers. You can read the article here.

There was a strong push by the Obama administration for a seven-year exclusivity limit.

According to the article:

"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.

But supporters of a shorter time limit say long-term data exclusivity gives profitable biotech companies an unfair monopoly on the costly drugs. They say their ability to make biosimilars - the lower-cost generic versions of the biotech drugs - will lead to lower health-care costs."

But the 12 year exclusivity period is by no means a done deal...the measure still needs approval buy the full House and Senate.

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