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FDAAA Luncheon on West Coast, A Huge Success

Left to right : Marcia Madrigal, Janet McDonald, Brian Harvey, Brian Healy, Mike Beatrice, James Bilstad, Emannuelle Voisin, Nancy Myers, Mamata Gokhale, John Shane and Jenen Jingwen Tan.

FDAAA hosted its first official West Coast luncheon at the Italian eatery 54 Mint in San Francisco. Organized by Mike Beatrice and Nancy Myers during the JP Morgan Healthcare Conference, the get together proved to be enjoyable and a wonderful way to meet new, yet connected friends. Our participants ranged from fully retired folks, to busy consultants to interesting guests. All who participated agreed that this was a great launch and that there is a real interest in organizing more West Coast events.

Thanks to VALIDANT for helping to underwrite our activity!

FDA and FDAAA Refresh MOU after 13 years

By: Nancy Bradish Myers & Ed Steele

FDA Commissioner Rob Califf and Nancy Bradish Myers, FDAAA Board Chair, show off the pen and signed MOU following the signing ceremony.

Participants in the MOU signing from left to right: Laurie Lenkel , Suzanne Jenod, Heidi Marchand, Rob Califf, Nancy Bradish Myers, Ed Steele, Mel Plaisier, and Pat Kuntze.

Pens in hand, cameras clicking, redrafted MOU before them in the Commissioner's Conference Room in White Oak's Building One, FDA Commissioner Robert Califf and Nancy Bradish Myers, FDA Alumni Association (FDAAA) Board Chair, renewed the two organizations' commitment to working collaboratively in order to benefit FDA alumni and current FDA staff.

The MOU refresh, an idea proposed by FDA earlier this Fall, renewed the commitment of both organizations' leadership to appreciate the synergies and unique relationship we enjoy, and signaled a "go-ahead" for FDAAA leaders and volunteers to envision programing that goes beyond what we are doing now. It was a nod toward breaking out of the grooved routines and familiarity we have had with the FDA and advancing further.

It was a very different level of pomp and circumstance than when the first MOU was announced by Commissioner Mark McClellan before a 600-person crowd at the 2003 FDLI Annual Meeting. Friday's signing was an intimate, thoughtful ceremony with supporters around a large conference table. It was lined with people familiar with the good work of FDAAA, like Mel Plaisier, Associate Commissioner for Regulatory Affairs, who praised our mentor program and international work; Suzanne Junod, representing the History Office; and Heidi Marchand and Pat Kuntze in FDA's Health and Constituent Affairs Office. Ed Steele, FDAAA President, also was present.

The refresh could not have come at a better time for the Alumni Association. As the Board of Directors is undergoing a strategic planning process and aligning on an updated vision for the organization, this MOU signing provided the opportunity to think even bigger.

"The cooperative relationship we have with the leadership of the FDA has been nothing short of outstanding. The signing of this refreshed MOU signals a commitment to build on our past successes so that the FDAAA can increase our support of FDA's consumer protection mission" "said, EAS President Ed Steele

In the conversation, Dr. Califf praised the unique relationship between the organizations. He pointed out that the alumni association is the institutional memory of the FDA. He used the example of the "fake news" phenomena and towns in Eastern Europe thriving on work using algorithms to develop fake news to feed to the American public. He pointed out how dangerous this is and highlighted the importance of institutional memory and that organizations with people steeped in the history of an institution like the Alumni Association will be invaluable in the future. Dr. Califf, himself a strong supporter of alumni groups stemming from his positive experience with Duke, has said, "I am delighted that we have so many active and engaged alumni and advocate that the relationship between FDA and FDAAA continue to strengthen."

During the ceremony, Myers took time reminded those around the table that the visionaries who hatched the idea of FDAAA in 2000 were Bob Eccleston, at the time with CDRH, and Kelly Sauer, a CDRH alumna. They recruited an enthusiastic John Villforth, former US Assistant Surgeon General and Director of CDRH, to "roll out" the organization in March of 2002. Obviously, there were many other FDAers who helped launch it, like: Burton Love, Liz Krell, Jim Bensen, Ron Chesemore and many others. The group accomplished a very important milestone: on March 3, 2003, Dr. Mark McClellan and John Villforth signed an MOU at FDLI's annual meeting. For more information, please read the following history.

The next step will be a "refresh meeting" between FDA and FDAA in January or February, in order to explore expansion of our current programs and brainstorming for new initiatives.

One key point came up again and again, and was echoed in a comment by Dr. Kathy Zoon, former CBER Director, at a recent Board meeting; everyone agrees that "Once an FDAer, Always an FDAer." It gets in your soul.

To read the new MOU click here. To see a list of other MOUs FDA has signed in the past, click here.

FDAAA's Hail to the Chief Counsels and Their Deputies a Resounding Success

On the rainy evening of December 6, 2016, more than 130 FDAAA members and their guests gathered at the shiny, new offices of Arnold & Porter to pay tribute to of FDA Chief Counsels and their deputies who had served over the past 45 years.

Mark Raza, Current Deputy Chief Counsel; Ed Steele, FDAAA Presdient; Jeff Springer, Deputy Chief Counsel 2005 - 2007; Jeff Senger, Deputy Chief Counsel - 2011; Jerry Masoudi, Deputy Chief Counsel - 2010 - 2011, Chief Counsel - 2007 - 2009; Liz Dickinson, Current Chief Counsel; Richard Cooper, Chief Counsel - 1977 - 1979; Peter Barton Hutt, Chief Counsel 1971- 1975; Nancy Myers, Chairwoman of the Board, FDAAA; and Sheldon Bradshaw, Chief Counsel 2005 - 2007.

The event was attended by a diverse audience of FDA staff and FDA alumni of all different backgrounds and professions. Many of the attendees had served under one or more of the honorees at some point during their FDA career.

Each Chief Counsel or Deputy Chief Counsel was asked to introduce his successor. It was clear from the warm and wise-cracking tone of the introductions that there is a true camaraderie and respect that is passed from one generation to the next at the FDA Chief Counselā??s office. The weight of the importance of the role in shaping food and drug law was not lost on any of those who had served or who currently serve.

Guests mixed and mingled while overlooking the DC skyline.

Dan Krakov, Stuart Pape, and Joe Levitt

Jessica O'Connell, Nicole Smith, and Haley Kropa

Jerry Masoudi and Peter Barton Hutt

Kirsten Paulson and Mitchell Stein

The event was generously hosted by Arnold & Porter LLP, and sponsored by: Biotech Policy Group, Catalyst Healthcare Consulting, Covington & Burling LLP, EAS Consulting Group, Greenleaf Health, Hogan Lovells US LLP, Hyman Phelps & McNamara, PC, Keller & Heckman LLP, Polsinelli PC, and Sidley Austin LLP.

Links to Recent FDAAA Events and Announcements

Recent FDAAA Events

Announcements