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Media Release: November 15, 2011


FDA to receive $2.5 billion appropriation; $50 million above FY 11

WASHINGTON, D.C., November 15, 2011 – The Alliance for a Stronger FDA praised House and Senate conferees for providing FDA with an FY 12 appropriation of $2.5 billion, a $50 million increase over FY 11.

“We are grateful to the conferees for assuring that FDA has the funds to continue its mission,” said Nancy Bradish Myers, President of the Alliance for a Stronger FDA and President of Catalyst Healthcare Consulting. “FDA must continue to be a national priority so that we can advance medical progress, improve patients’ lives, and assure Americans have a safe food supply.”

The additional funds are directed to be spent on implementing the new food safety law and continuing FDA’s efforts to advance medical countermeasures against bioterror attacks. Apart from that, FDA’s centers and offices will have about the same spending levels as in FY 11.

“FDA’s overall mission and responsibilities continue to grow each year. In an era of remarkable advancements in genomics and the life sciences, FDA will continue to play a significant role in driving biomedical innovation for patients,” said Andrew Emmett, an Alliance Board member and Managing Director, Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO). “In addition to new mandates, the agency faces increased challenges from globalization of our food and drug supplies and the increasing scientific complexity of regulatory filings.”

“We count on FDA to continue to make sure our foods are safe, regardless of origin,” said Christopher Waldrop, an Alliance Board Member and Director of the Consumer Federation of America’s Food Policy Institute.  “As Americans enjoy more foods from overseas, the agency must invest several times more effort in import safety than it has in the recent past.”

“We are pleased with the Congress’ commitment to begin funding the new food safety law.” said Margaret Anderson, Vice President of the Alliance and Executive Director of FasterCures.  “We remain concerned that investment has not increased in the critical area of medical product development—the quality and safety of the drugs, vaccines and devices upon which patients rely.”

As part of its critical public health mission, FDA oversees nearly 25% of all consumer spending. The economic impact of the industries and products the agency oversees is enormous—and has the potential to lead growth in our economy and job development (see the Alliance’s white paper on the economic impact of FDA).

Reflecting on the breadth of FDA’s mandate, Diane Dorman, an Alliance Board Member and Senior Vice President for Public Affairs at NORD noted: “Multiple times every day, Americans use products for which FDA has oversight responsibilities. There is no back-up if the agency isn’t there.”

“FDA’s job is much like national defense — essential to our nation’s well-being — and providing protection that is too often taken for granted until a crisis occurs,” added Richard Buckley, an Alliance Board Member and Vice President, Federal Government Affairs, AstraZeneca. “A strong FDA is welcomed by the industries it oversees and spurs innovation that drives our economy.”

FDA is committed to a number of new initiatives that are critical to promoting the public health and are resource-intensive. It is implementing the Food Safety Modernization Act and legislation that created an abbreviated approval pathway for bio-similar drugs.  In June, the FDA released a special report, entitled Pathway to Global Product Safety and Quality, which documents the growth in imported products, including food, drugs, and medical devices. Early this fall, FDA released a report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients.

The Alliance for a Stronger FDA’s 180 members — comprised of consumer, patient, professional and research groups, companies, trade associations, and individuals — represent millions of Americans who support increased appropriated funding for FDA. The Alliance’s recent advocacy ads on behalf of FDA funding can be found on the Alliance web site.

More information about the Alliance can be found at

Attachment: Chart comparing FDA FY 12 appropriations to FY 10 and FY 11.