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President Obama's Fiscal Year 2010 (FY 2010) budget includes support for a regulatory pathway for follow-on biologics.
The new administration is not wasting any time in tackling tough pharmaceutical industry issues. Funding for comparative effectiveness research and health information technology ($1.1 billion and $19 billion, respectively) were included in the economic stimulus package signed late last month (see back stories here and here). And now, President Obama’s Fiscal Year 2010 (FY 2010) budget includes support for a regulatory pathway for follow-on biologics.
Although the final full budget will not be presented to Congress for a few more weeks, Obama’s preliminary budget summary tables predict that FDA approval of generic biologic drugs could lead to a decrease in the national deficit of $10 million by 2014. As for data exclusivity, it’s unclear the exact time the administration will push for. The 1984 Hatch-Waxman Act provides for up to five years of data exclusivity for innovator firms of small molecules, but industry groups such as the Biotechnology Industry Organization prefer 14 years for large molecules, or biologics, and the Generic Pharmaceutical Association prefers something closer to the Hatch-Waxman rules for follow-on biologics.
The overall proposed budget includes $76.8 billion in funding for the Department of Health and Human Services with provisions to support efforts by the US Food and Drug Administration to ensure drug safety and effectiveness. It also includes $6 billion (in addition to the $10 billion included in the economic stimulus package) for the National Institutes of Health to support cancer research. The budget summary proposes to increase resources for HIV/AIDS prevention and treatment as well.