BIO Urges Congress to Further Increase FDA Budget.

Commends President for Proposed Funding Increases to FDA, Pandemic Preparedness and Biodefense Countermeasures 

WASHINGTON -- The Biotechnology Industry Organization (BIO) praised the proposed budget for FY2008 announced earlier this week by President Bush as a good starting point and urged Congress to further increase funding for the Food and Drug Administration (FDA).

"It is critical to ensure that the FDA has the resources necessary to fulfill its mission of guaranteeing the safety, efficacy and security of the products it regulates. Congress must increase funding to keep pace with the enhanced mandate of the FDA, which has expanded to include pandemic disease preparedness as well as food safety and other counter-terrorism activities," stated BIO President and CEO Jim Greenwood.

The President's proposed budget for the FDA includes increases of $11.2 million to modernize drug safety programs, $10.6 million for food safety programs, and $7.2 million for medical device safety and review programs.

"Adequate support for FDA is particularly important as the agency prepares to address the coming wave of exciting new biomedical advances. Without appropriate resources at the FDA, new therapies for major diseases could be significantly slowed. Companies could face increased difficulty in obtaining funding for innovative research and development without a clear review and approval timeline. Consumer confidence in food and drug safety will erode," Greenwood continued. "While we fully support the agreement we have reached with FDA regarding reauthorizing drug user fees, it is clear that the balance between user fees and appropriations has gone beyond what was ever initially contemplated. Now is the time for a substantial increase in FDA appropriations."

Greenwood commended the President for the proposed $1.2 billion for HHS-wide funding as the final installment of the $7.1 billion for pandemic preparedness that he announced in November 2005.

"We applaud this important public-private partnership that is critical to advance the nation's pandemic preparedness. We hope that HHS will engage the full spectrum of the biotechnology industry, including cell-culture and next-generation vaccines, currently available and next generation antivirals, and rapid diagnostics," Greenwood stated. "We also applaud the funding for advanced research and development of biodefense medical countermeasures, including the proposed $211 million for the Assistant Secretary for Preparedness and Response to target advanced research and development of promising medical countermeasures and to manage the Project BioShield program."

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world's largest biotechnology conference and exhibition. www.bio.org

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