WASHINGTON, Oct. 11, 2012 /PRNewswire/ — The Food and Drug Administration Alumni Association (FDAAA) received The Frances O. Kelsey Award for Excellence and Courage in Protecting the Public Health at an October 2 FDA ceremony marking the 50^th anniversary of the passage of the 1962 Kefauver-Harris Amendments to the 1938 Federal Food, Drug, and Cosmetic Act.

The FDA created the award in 2010 in honor of Dr. Frances O. Kelsey, who was also its first recipient at age 96. Not long after she joined the agency in 1960, Dr. Kelsey became a national heroine because of her fateful decision to withhold approval for the thalidomide sleeping pill in the U.S., a drug soon linked to scores of birth defects throughout Europe. She went on to play a key role in shaping and enforcing the Kefauver-Harris Amendments, which gave the agency authority to require additional testing of new drugs to demonstrate their effectiveness. Dr. Kelsey retired from the FDA in 2005 at age 90.

“We decided, moving a little bit afield from the original vision for the Frances O. Kelsey Award, that we would award it to the FDA Alumni Association,” said FDA Commissioner Dr. Margaret Hamburg, at the October 2 commemoration held at FDA’s headquarters in White Oak, MD. Dr. Hamburg presented the Award to FDAAA as an acknowledgement of the “many contributions that have been made by people who have worked hard during their tenure at the FDA, continue to support the FDA in critical ways now, but today are a part of the FDA Alumni Association.”

“FDA employees today are making a huge difference, but as we reflect in a historical context on all that’s been accomplished, we also want to recognize FDA employees past,” she stated.

“… I think it is very, very fitting to acknowledge FDA employees current and past in this way,” she said.

In accepting the award on behalf of the FDAAA, Board Chairman Joseph Levitt said, “There are no words to express the honor and pride we all feel. Dr. Kelsey is an iconic figure in FDA history, personifying the very highest ideals of public health protection and public service. There are hundreds, if not thousands, of FDA’ers who have followed in Dr. Kelsey’s footsteps to protect the public health through a career dedicated to public service.”

Mr. Levitt added: “This award also exemplifies the special kinship that so clearly exists between the agency and its many alumni. We all devoted so much of our lives to our FDA careers due to our belief in the importance of the agency’s mission and the unique esprit de corps that has always existed among FDA employees. That kinship does not end with retirement.”

FDAAA President Alan Andersen added, “Our activities range from global ones like FDAAA International Network’s work with foreign regulators and establishment of a scholarship fund to help graduate more quality assurance/regulatory affairs professionals, to the more local efforts of alumni offering career lessons learned to new agency employees in the Commissioner’s Fellowship program. We are constantly seeking new impactful ways our FDA alumni members can continue to advance the agency’s public health mission while supporting our former colleagues still working at the agency. We hope FDA feels like we are just a phone call away.”

The commemorative event featured remarks on the significance of the Kefauver Harris Amendments from FDA Associate Commissioner for External Affairs, Virginia Cox; FDA Commissioner, Dr. Margaret Hamburg; FDA Deputy Commissioner for Medical Products and Tobacco, Dr. Stephen Spielberg; Executive Director, Thalidomide Victims Association of Canada, Mercedes Benegbi; FDA Deputy Commissioner for Global Regulatory Operations and Policy, Deborah Autor; FDAAA Chairman of the Board, Joseph Levitt; and Deputy Director, FDA Center for Drug Evaluation and Research, Dr. Douglas Throckmorton. A link to a full webcast of the commemorative event is available at www.fdaaa.org under Latest Events.

FDAAA Chairman of the Board, Joseph Levitt, and FDAAA President Alan Andersen, received the award on behalf of their colleagues.

Founded in 2001, the FDAAA is a non-profit, non-lobbying organization dedicated to serving those who have supported the consumer protection mission of the FDA as well as helping their alumni stay in touch with the issues facing the Agency.

For further information, please contact: Edward A. Steele, Chairman, FDAAA Communications Committee [esteele@easconsultinggroup.com], 703-684-4408.

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SOURCE Food and Drug Administration Alumni Association