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2012: A Critical Year for Biotechnology

December 21, 2011
In 2012, we must continue to look for ways to reduce risk; enhance reward; reduce uncertainty; and reinforce the position of the industry as a major contributor resolving society’s most pressing needs. Policies to encourage investment in innovation and to speed discovery to scientific breakthroughs simply must be the priority in 2012.

The industry relies on a policy and regulatory environment that encourages innovation for much needed treatments and cures for some of the most devastating and life threatening diseases. BIO will continue to engage with leaders in Washington to ensure that policies support an economic environment that encourages innovation and enables our members to saves lives and transform our world.

BIO has developed a comprehensive national policy strategy – Unleashing the Promise of Biotechnology – designed to incentivize investors, strengthen small business, and promote innovation in the U.S.

The creation of a 21st century Food and Drug Administration (FDA) is critical right now. Congress must provide the FDA with the resources it needs to keep pace with rapidly evolving biomedical science and fulfill its vital health and safety mission. The FDA must recognizes its national role in advancing innovation by reviewing innovative products in a timely manner and promoting a consistent and science-based decision making process that is reflective of patient needs.

Strengthening the FDA's review process is also a focus of our ongoing discussions with policymakers about the next renewal of the Prescription Drug User Fee Act (PDUFA V) to get back-to-basics for patients based on principles that are science-based and transparent. The review process should be well-managed to appropriately balance benefits and risks, enhance public trust, and increase patient access to new medicines.

The Therapeutic Discovery Project (TDP) program, enacted in 2010, is an example of the type of policies necessary to spur continued medical innovation, while at the same time protecting and growing high-paying U.S. jobs. The TDP program provided $1 billion in research grants and credits for small biotech companies pursuing new therapies for diseases such as Alzheimer's, HIV/AIDs, Parkinson’s and MS. BIO is now calling on Congress and the Administration to work together to extend and expand the Therapeutic Discovery Project in early 2012 to support continued American innovation and further accelerate the development of life-saving cures.

Furthermore, current tax law does not do enough to foster investment in health care, green technology, or energy-focused biotechnology companies. Given the economic and societal benefits of ensuring a robust biotech industry, it is imperative that Congress and the Administration adopt policies that recognize the unique financial structure and capital needs of biotech companies.

Other BIO policy priorities include ensuring the National Institutes of Health has sufficient funding to sustain the public-private collaboration that is transforming biomedical discoveries into innovative treatments for patients.

In addition, along with our state affiliates, we will continue to work with states governments seeking to grow their biotech sectors as part of their economic development and job creation strategies.

[caption id="attachment_3732" align="aligncenter" width="400" caption="Learn more about BIO's 2012 priorities in a podcast with Brent Del Monte, BIO's Vice President of Federal Government Relations"][/caption]