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Media Release: August 19, 2010

DHHS SECRETARY SEBELIUS DECLARES INVESTMENT IN FDA REGULATORY SCIENCE TO BE A CRITICAL COMPONENT OF NATIONAL SECURITY

New HHS Report Highlights FDA’s Role in Countermeasures to Be Used During a Bioterror Attack

WASHINGTON, D.C., August 19, 2010 — The Alliance for a Stronger FDA today praised HHS Secretary Kathleen Sebelius for her forthright advocacy for regulatory science at FDA. At a press conference this morning, the Secretary highlighted regulatory science as part of a long-anticipated report reviewing the development and approval of Medical Countermeasures (MCM) that would protect Americans from a bioterrorism incident or a naturally occurring emerging infectious disease.

“We appreciate the Secretary’s recognition of the importance of FDA’s regulatory science initiative and her highlighting of FDA’s vital role in national security,” said Wayne Pines, President of the Alliance. “Strengthening regulatory science at FDA is a priority for Commissioner Hamburg and should be a national priority. This program needs to be well-funded so that the FDA can continue to develop and expand its scientific capacity.”

The HHS press release states: “The review identified a need to upgrade science and regulatory capacity at the FDA. As a result, HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market.”

“All Americans agree that our national priority is to prevent and respond to bioterrorism and naturally occurring infectious diseases,” said Nancy Myers, Vice President of the Alliance. “FDA’s role is to support the development of MCM products and approve those that meet the standards FDA has set.”

The Alliance for a Stronger FDA is a coalition of more than 180 consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA.  The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities.

The new HHS press release and report are at:

If you wish to receive more information about the FY 2011 and FY 2012 appropriations cycles and why FDA needs increased funding, please send an e-mail to info@StrengthenFDA.org.

More information about the Alliance can be found at www.StrengthenFDA.org.