Senate Committee Approves Healthcare Bill with 12-Year Data Exclusivity for Innovator Biologics

July 16, 2009

The Senate?s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee?s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.

The Senate’s Health, Education, Labor, and Pensions Committee yesterday passed The Affordable Health Choices Act, the committee’s healthcare reform legislation that gives 12 years of data exclusivity to innovator biologics. The committee had adopted the 12-year data protection amendment to the healthcare legislation on Monday.

Last week, the Biotechnology Industry Organization (BIO) was rounding up support for a 12-year data exclusivity period for biologics. Recently, the AARP issued a statement indicating that the 12-year data exclusivity period was “unreasonable.” A letter was also sent by the Obama administration advocating for seven years of data exclusivity, which followed the FTC’s report indicating that there is no need for a 12- to 14-year data exclusivity period.

BIO President Jim Greenwood was pleased with the decision of the committee. “It was a stunning victory that few would have predicted was possible less than two weeks ago,” he wrote in a posting on BIO’s web site. “We are still a long way from finished. We might face battles on the Senate floor as well as in the House. But so far, so good.”

Previous coverage:BIO Seeking to Round Up Support for 12-Years Data Exclusivity

14 Years of Market Exclusivity Unnecessary, says FTC

Jim Greenwood’s post on BIO’s web site