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President’s Proposed 2017 Budget Poses Threat to Medical Innovation

February 9, 2016

Washington, D.C. (February 9, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Obama’s FY 2017 budget proposal:

“Elements of the President’s budget proposal for 2017 directly threaten his Administration’s goal of curing cancer through advances in precision medicine. The budget’s proposed changes to biologic data exclusivity, cuts to Medicare Part D and B, emphasis on switching patients to the lowest cost treatment as opposed to the drug that their doctors think are best for them, will significantly and negatively affect the development of innovative medicines, particularly biological products needed to provide the foundation for the Administration's "moonshot" initiative.

“These proposals and others in this budget will severely restrict the ability of innovative biomedical companies to recoup their enormous investments in innovation, ultimately limiting patient access to therapies for diseases such as cancer, Alzheimer's, diabetes and many others.

“We oppose cuts or changes to Medicare Parts B and D, which are both working well to ensure patient access to life-changing and life-saving therapies. We should not disrupt these successful programs by making arbitrary changes that will put at risk patient access to necessary medicines.

“The Administration’s proposal to reduce the period of regulatory data protection for innovative biologics manufacturers will jeopardize the careful, overwhelmingly bipartisan balance established in the law to reduce costs, expand access, and encourage continued innovation – innovation that creates good, high-paying biotech jobs and leads to breakthrough therapies and cures. This repeated attempt in every proposed Administration budget paints a target on the very innovation that holds the greatest promise for the future.

“In addition, BIO is deeply troubled by the proposed funding cuts for the Project BioShield Special Reserve Fund and the Biomedical Advanced Research and Development Authority's (BARDA's) pandemic influenza program, which would undermine the public-private partnership by discouraging manufacturers from investing in research and development of critical medical countermeasures.

“While the above proposals directly jeopardize future medical innovation, there are elements within the President’s budget we find critically important. These include continued funding for support of the President’s signature Precision Medicine and BRAIN Initiatives, as well as increased funding for innovative R&D, specifically basic research and advanced manufacturing technology. Investing in the next generation of modern medicines will help to accelerate the discovery, development and delivery of breakthrough cures and treatments that can save and improve lives.

“BIO continues to emphasize the importance of agricultural research funding to further develop improved seeds that help farmers manage the challenges of climate change and increase the sustainability of our food production systems. These include crops, plants and trees that can tolerate environmental stresses and resist disease. In addition, we have seen innovations in animal biotechnology that enhance animal health, contribute to a more sustainable food supply, and provide life-saving human health therapies.

“BIO also supports the budget provisions related to investing in homegrown clean energy. BIO supports the Administration’s request to extend authorization of previous appropriations for the USDA’s biorefinery loan guarantees, which are vital to helping renewable chemical and advanced biofuel producers secure capital for large-scale, job creating projects in rural areas. BIO additionally supports the budget requests to continue the successful Navy/USDA/DOE collaboration that is supporting production and procurement of advanced biofuels for the U.S. military. To continue building the advanced biofuel industry around homegrown technology, the United States must provide stable, long-term investment incentives – such as the second-generation biofuel production tax credit – to U.S. companies. BIO is pleased the Administration extends the tax credit for second generation biofuel production through 2022; however, BIO is concerned about any proposal to phase out the credit. “We will continue to work with President Obama, members of his Administration and the Congress in pursuit of public policies that encourage investment in biotech innovation.”

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