Hill Leadership: Support Science-Based Assessments by FDA

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Aug 03, 2011, 10:41 ET

Animal Ag Coalition Members Denounce Political Interference in FDA Process

WASHINGTON, Aug. 3, 2011 /PRNewswire-USNewswire/ -- In a letter to Congressional Leadership, the Biotechnology Industry Organization (BIO) joined 37 agriculture organizations in urging Congress to support the U.S. Food and Drug Administration's (FDA) mandate to base its assessments on science.

During House consideration of H.R. 2112, the Fiscal Year 2012 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, an amendment was approved by voice vote that would, if allowed to become law, prohibit FDA from spending money in fiscal year 2012 on the pending approval of a genetically engineered salmon product that has been pending at FDA for a number of years.

"Disrupting FDA's science-based assessment process based on non-scientific political concerns would set a dangerous precedent in our country," said Jim Greenwood, BIO president and CEO. "It is critical that the scientific experts who work within FDA be allowed to conduct comprehensive scientific approvals without political influence."

The letter, signed by 38 members of the Animal Agriculture Coalition, was sent August 2 to House Speaker John Boehner, House Democratic Leader Nancy Pelosi, Senate Majority Leader Harry Reid and Senate Minority Leader Mitch McConnell.

"We do not write to support or oppose this specific application, but rather to register our concern with the House's action, which if allowed to become law, would disrupt the FDA's Congressional mandate to base its assessments of human and animal drugs, devices, vaccines, and process applications on the best-available science underlying an application," the letter states. "Such a disruption would diminish the credibility of the FDA approval process at home and overseas. The global reputation of FDA's science-based review procedure is based on the Agency's objectivity."

*A copy of the letter is posted online at http://www.bio.org/advocacy/letters/animal-biotechnology-letter-support-science-based-review-process-fda.

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

Upcoming BIO Events

BIO India International Partnering Conference

September 21-22, 2011

Hyderabad, India

BIO China International Conference

October 12-13, 2011

Shanghai, China

10th Annual BIO Investor Forum

October 25-26, 2011

San Francisco, Calif.

BIO-Europe 2011

October 31-November 2, 2011