After setting an ambitious goal of reforming healthcare in 2009 in his Tuesday night address, President Barack Obama will release a budget later today that will make it easier for follow-on biologics to be approved by the government. Currently the U.S. Food and Drug Administration (FDA) has no process for approving follow-on biologics, or FOBs, and there are no set rules on patient protection. Industry leaders believe that patient safety and data protection for innovators should be strongly considered in order for innovators to continue to fund research and development of novel new therapies and technologies.  However, sources say that the Obama administration will follow the same rules set for conventional drugs under the 1984 Hatch-Waxman Act, which has patents expire after three to five years.  Considering the cost and time it takes to bring a new therapy to the market, 15 years and hundreds of millions of dollars, it is critical to continued biotechnology investment and innovation for policy to reflect this high-risk development environment.

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