FDA Distinguished Alumni Award

Description: This is an FDA-sponsored award for which FDAAA is asked to nominate candidates. Recipients receive a personal letter signed by the Commissioner, plus an engraved crystal bowl. Items are presented at FDA's annual Honor Awards Ceremony.


Kathryn Zoon, Ph.D., NIAID, NIH

Kathryn Zoon, Ph.D. has a long and distinguished career as a government researcher, manager, mentor and leader. Kathy worked at FDA's Center for Biological Evaluation and Research (CBER) from 1980 to 2002, first as a bench scientist. of human interferons, then as the Center Director (1992 - 2002). She is a well-recognized champion for scientific excellence and led the Center at a time of enormous growth and change. Kathy left FDA in 2002 to serve as principal Deputy Director at NIH's National Cancer Institute. In 2006, Kathy joined NIH's National Institute for Allergy and Infectious Diseases to continue her research on the structure and function of human interferons. She also serves on the World Health Organization (WHO) Expert Committee on Biological Standardization. Since leaving FDA, Kathy continues her leadership in public health and the development of new therapies to enhance public health. Kathy's work represents the best in bridging drug and vaccine development with regulatory review, evaluation and marketing approval.

All Recipients - see the full list of FDA Distinguished Alumni Award recipients

Eligibility: Former FDA employees who left the agency at least five (5) years ago and meet the following criteria:

  • have a continuing and major impact on FDA as a whole;
  • reflect FDA's values; and
  • exemplify an outstanding commitment to meeting the agency's mission of protecting the public health.

Selection: Nominations can be made by any Association member. Nominations must be directed to the Awards Committee ( The Awards Committee will screen all nominations and forward recommendations to the Board of Directors for final decision. The names of FDAAA nominees will then be forwarded to FDA's Awards Coordinator for presentation to the agency's Executive Council. The FDA Commissioner will make the final selection(s).

The Harvey W. Wiley Lecture

Description: A lectureship named in honor of Dr. Harvey W. Wiley, the renowned physician-chemist who, at the turn of the 20th century, championed a legislative crusade against food adulteration, earning him the title of "Father of the Pure Food and Drugs Act" when it was enacted into law in 1906. The Lecture will be presented at the FDAAA Annual Meeting each April.

2016 Harvey W. Wiley Lecturer

Mark B. McClellan, M.D., Ph.D.,
Duke Margolis Center for Health Policy, Durham, NC

All Harvey W. Wiley Lecturers - see list of all Harvey W. Wiley Lecturers

Eligibility: Lecturers shall be prominent figures from the fields of public health, health research, public health education, health care delivery, science journalism, food and drug law, and public policy-making, who can:

  • promote broader public enlightenment of, and support for, the mission of FDA;
  • provide intellectually stimulating, futurist perspectives on 21st century roles of the FDA in public health;
  • initiate a meaningful dialogue on innovative ways the FDAAA and its membership can impact the current and future mission of the FDA and its capacities to protect and promote the public health.

Selection: Suggestions for Lecturers can be made by any Association member and must be directed to the Activities Committee ( for initial consideration. Final invitations to Wiley Lecturers will be made by the Chairman of the Board.

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Previous Speeches

FDAAA Founder's Award Recipients

Description: The Founder's Award was approved by the Board in January, 2011. In this, the tenth year of the FDAAA, it was decided that honoring the founders of the organization in the inaugural year of the award was most appropriate! The Founder's Award was established to honor the members of the FDAAA who have served with distinction in a leadership capacity, i.e. Board members or Committee Chairs who:

  • Made significant and visible contributions to promoting the growth and/or visibility of the FDAAA;
  • Have served more than one term on the Board and in so doing have advanced the organization's goals and mission;
  • Exemplifies the true spirit and intention of the motto: "Serving those who have served".

2016 Founder's Award Recipient

Edward Steele

Edward A. Steele,
EAS Consulting Group, LLC

Recipients of the FDAAA Founder's Awards - See list of recipients

2015 Volunteer of the Year Recipient

Andy Bonanno

Andy Bonanno

Dan Michels

Dan Michels

Recipients of the FDAAA Volunteer of the Year Awards - See list of recipients

Eligibility: Members of good standing of the FDAAA who:

  • make extraordinary contributions to the growth, viability and image of the FDAAA or to an affiliated chapter over a sustained period of time; or
  • demonstrate highly accomplished leadership in the development and conduct of Association programs; or
  • represent the Association in one or more extramural activities in a manner that positively reflects the ideals of the organization and substantially benefits the FDA or public health in general.

Selection: Nominations can originate from any Association member and must be directed to the Awards Committee ( for consideration. Final selections(s) will be made by the Board of Directors based on the Committee's recommendation(s). This award can be presented to one or more persons each year at the discretion of the Board of Directors. The award(s) will be presented at the Association's annual meeting in April.

FDAAA Service Recognition Award

Description: Recipients receive a finely-crafted wooden desktop case emblazoned with the FDAAA logo.

2016 Service Recognition Award

Fredda C Shere-Valenti

Fredda C. Shere-Valenti

Donald J Sauer

Donald J. Sauer

Recipients of the FDAAA Service Recognition Award - See the full list of recipients

Eligibility: Persons who serve in leadership positions of the Association (e.g., Officer, member of the Board of Directors, Committee Chair) and whose service has a demonstrably positive effect on the growth, operational success and/or public image of the organization.

Selection: Nominations will be accepted from any FDAAA member and must be directed to the Awards Committee ( for consideration. The Awards Committee will make recommendations on all Service Recognition Award nominations to the Executive Committee and, if necessary, to the Board of Directors which will render a final decision. Service Recognition Awards may be presented at any time during the calendar year at the discretion of the Board of Directors, including the Association?s annual meeting in April.

FDAAA Certificate of Appreciation

Description: A standardized, specially designed certificate bearing the FDAAA logo, recipient's name, date, signatures of the Chairman of the Board of Directors and the FDAAA President, and a citation describing the recipient's contribution(s).

2016 Certificate of Appreciation Recipient

Karen L Carson

Karen L. Carson

Recipients of the FDAAA Certificate of Appreciation - See list of recipients

Eligibility: Any individual who is an FDAAA member or non-member, or entity, who/that:

  • makes a remarkable contribution, either on a one-time or continuing basis, to the operation or financial standing of the Association (e.g., pro bono services, large donation);
  • provides highly-dependable, productive volunteer service to the FDAAA;
  • serves in an appointed or elected position of responsibility in the FDAAA;
  • is a guest speaker or participant at an FDAAA-sponsored event;
  • performs a charitable act that exemplifies the goal and values of the FDAAA;
  • offers a unique idea or recommendation that is adopted and enhances the efficiency, effectiveness and/or integrity of the FDAAA;

Selection Requirements: Nominations can originate from any member of the Association and must be directed to Executive Committee via the FDAAA Secretary ( for consideration. Final selection will be made by the Executive Committee. Certificate presentations can occur anytime at the discretion of the Board of Directors.

Participants (retirees from FDA) in Pilot Mentoring Program for ORA/FDA


Louise W. Amolie
Gary J. Dykstra
Arlyn Baumgarten
Malcolm Frazier
Thomas Gardine
Richard Garwood
Carolyn White
Paul Raines
Emma Singleton
James Strachan
Tyler Thornburg
John Thorsky

Innovator's Award*

FDA Alumni Advisor Design Group. This was a group award for the following FDA employees who successfully developed a process to re-hire FDA retirees to mentor current employees in leadership skills and career development, having an immediate and positive impact on FDA.


  1. Patricia Alcock - Director, Division of Human Resource Development, ORA
  2. Loney Nunemaker - Deputy Director, Division of Human Resource Development, ORA
  3. Brooke Mullican - Manager, Division of Human Resource Development, ORA
  4. Denise Collins - Program Lead/Training Officer, Division of Human Resource Development, ORA
  5. Rosemary Warneke - Consultant, Office of Resource Management, ORA

These employees worked collaboratively to design a process to re-hire twelve former senior FDA employees who had retired with many years of management and leadership experience, and to return them on a part time basis as rehired annuitants. Their areas of strength were identified and they were matched with all level managers from the Office of Regulatory Affairs (ORA) who had identified the same leadership competencies as developmental needs. The resulting advisor/learner relationships were nurtured in a pilot program called the FDA Alumni Advisor Program that began in June 2015 and concluded in March 2016.

*This is a new award created by FDAAA to recognize innovation with current FDA employees.