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Media Release: April 7, 2010

ALLIANCE FOR A STRONGER FDA APPLAUDS FDA’S NEW ACCOUNTABILITY INITIATIVE

FDA Track Seen as a Positive Step Towards More Accountability and Greater Transparency at FDA

SILVER SPRING, MD, April 7, 2010 — The Alliance for a Stronger FDA today applauded the FDA’s new accountability initiative, called FDA Track. The Alliance said it represents a “positive step toward improved management by objectives, more accountability and greater transparency.”

“It is an enormous undertaking to create a systemic approach to measuring progress within FDA,” said Wayne Pines, President of the Alliance and President of Regulatory Services and Healthcare at APCO Worldwide. “The Alliance views this as a positive step and supports FDA’s effort. We look forward to working with the agency to make this important initiative a success.”

As part of an HHS-wide and government-wide initiative to increase transparency and accountability, FDA has launched the FDA Track program that will eventually have as many as 1,000 metrics covering every office and program in the agency. Principal Deputy Commissioner Joshua Sharfstein, MD has experience running a similar system in the city health department in Baltimore.

“FDA leadership has made a commitment to be among the first government agencies to respond to President Obama’s call for more open and accountable government,” said Caroline Smith DeWaal, an Alliance board member and Food Safety Director at the Center for Science in the Public Interest. “The challenge is great, but the benefit to the FDA and the American people should be substantial.”

“This is a bold but needed undertaking as FDA works to regain public confidence and respect,” said Nancy Bradish Myers, Vice President of the Alliance and President of Catalyst Healthcare Consulting. “Over the next two to three years, as FDA Track evolves and adapts, we expect it will become an important tool for the Agency to demonstrate to Congress and the American people that FDA is a good investment, and that it is using appropriated dollars wisely. FDA needs to be transparent and accountable now because, as demands on the agency grow, so must its share of public funding.”

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