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Fight Over User Fees Underscores Bigger Questions About FDA's Mission and Relationship With the Companies It Regulates, Burrill & Company Report Finds

May 19, 2011

SAN FRANCISCO, CA--(May 19, 2011) - Industry frustration is growing over a failure to adequately fund the U.S. Food and Drug Administration and ensure its commitment to review drugs in a timely manner as Congress crafts legislation to allow the agency to continue collecting fees from drugmakers to review their products.

Biotech 2011-Life Science: Looking Back to See Ahead, Burrill & Company's 25th annual report on the biotech industry, examines the evolution of the Prescription Drug User Fee Act (PDUFA) and what's at stake for the industry, the FDA, and patients in the emerging fight over the fifth incarnation of the legislation. The current version of the law is set to expire in September 2012.

"There's no doubt that the FDA is underfunded and in need of greater resources, but user fees alone were never meant to meet the growing demands on the agency," says G. Steven Burrill, CEO of the San Francisco-based merchant bank Burrill & Company. "They were designed to address a need for resources to ensure a timely review of new drugs, but growing fees in recent years have not translated into the types of improvements seen in the early years of PDUFA."

Biotech 2011 examines how PDUFA in its early incarnation included provisions that allowed for speedier reviews of drugs to help patients with life threatening diseases obtain faster access to needed medicines. It also looks at how the legislation more recently has been used to address broader concerns of lawmakers about issues such as drug safety.

"Clearly the industry has a growing concern over a lack of predictability in terms of what it will take to get a drug approved at the FDA and are questioning whether they are getting their money's worth from user fees," says Mr. Burrill. "The risk is that the uncertainty will lead companies to think of the agency as a barrier to the market and instead will look overseas to bring new and innovative products to market."

This is one of the many issues explored in Biotech 2011-Life Sciences: Looking Back to See Ahead. Other sections of the book consider healthcare reform, the transformation to personalized medicine, regulation and policy reshaping the industry, development in industrial and agricultural biotechnology, the changing financing environment, and the growing importance of emerging economies within the industry. For detailed information and to purchase Biotech 2011 - Life Sciences: Looking Back to See Ahead, available in print and digitally, visit http://www.burrillandco.com/resources.html.

About Burrill & Company
Founded in 1994, Burrill & Company is a diversified global financial services firm focused on the life sciences industry. With more than $1 billion in assets under management, the firm's businesses include venture capital, private equity, merchant banking, and media. By leveraging the scientific and business networks of its investment team, Burrill & Company has established unrivaled access and visibility in the life sciences industry. This unique combination of resources and capabilities enables the company to provide life sciences companies with capital, management expertise, insight, market intelligence, and analysis through its investments, conferences, and publications. Headquartered in San Francisco, the company oversees a global network of offices throughout the United States, Latin America, Europe and Asia.

Upcoming Burrill & Company Events
The 2nd Annual Burrill Pan-Asia Life Sciences Meeting
June 26, 2011. Washington, D.C.
http://www.burrillandco.com/pan_asia_2011/

The Burrill Personalized Medicine Meeting
October 3-4, 2011. Burlingame, CA
http://www.burrillandco.com/personalized_medicine_2011/

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