"The FDA Alumni Association is the official global network of former and current FDA employees, connecting and supporting alumni, the Agency, and the public health community"
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For almost a decade FDAAA has sponsored an FDA history educational session for the FDA Fellows, a group of young professionals working at the agency, many of whom will become permanent employees. This year the panel was, from left, FDAAA members Wayne Pines, Nancy Myers, Andrea Chamblee, Brian Harvey and Coleen Klasmeier. Some of the Fellows actually joined FDAAA after the half day session, which also included a lecture from FDA historian Suzanne Junod and a presentation on FDA's budget by Steven Grossman of the Alliance for a Stronger FDA.
On January 19, 2018, a glimmer of spring was in the air as a crowd of over 40 FDA Alumni Association members gathered in the sunny Terrace Dining Room at Mrs. K's Tollhouse restaurant in Silver Spring for an informative lunch with Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research (CBER). While enjoying a delicious buffet (that finished with amazing cookies), current and former employees from across the Agency enjoyed the informal setting in which Dr. Marks discussed a wide array of topics, from recent FDA approvals of CAR-T cell therapies, innovative new developments in the stem cell arena, and a preview of CBER priorities for 2018. We are grateful that Dr. Marks could take the time to spend with our members. Please stay tuned for future FDAAA events!
FDAAA held its second annual West Coast Networking Event in early January during the 36th Annual J.P. Morgan Healthcare Conference in San Francisco. More than 30 FDA alumni and guests - triple the attendees from the previous year - gathered at the popular Hotel Zetta to reconnect with old colleagues and make new contacts. We look forward to having an equally successful event next year!
This year, in Washington, DC, we honored FDA Associate Commissioners for Regulatory Affairs (all those ACRAs over the years) and FDA Deputy Commissioners for Global Regulatory Operations and Policy.
FDA Needs Help with Recalls!
The FDA is looking for FDA retirees with field experience in recalls to help out with the device program recall work. They have been unable to keep up with the large quantity of device recall work needed to assure timeframes are met for device recalls. Experience in the FDA recall system, RES, would be helpful.
Qualified retirees will be paid under the Fusion Point Contract. For more information regarding the job duties, pay, and hours available contact:
FDA, Blake Bevill, Director of Compliance, Office of Medical Device and Radiological Health Office, Division 2 Central, Cell # 949-241-2322 or email email@example.com
FDA's Office of Training, Education & Development (OTED), Office of Regulatory Affairs, is announcing the new, redesigned FDA Alumni Advisor Program (FDAAAP). The new program will start in the 1st Quarter FY2018 (between October and December 2017).
The new program is highly anticipated and has been fully approved by senior leadership. It is based on the very successful, award-winning pilot program that ended last year and that was developed with the FDA Alumni Association.
Learning from the pilot, FDA has incorporated improvements into the new program. For example, the pilot matched Learners and Advisors with like leadership competencies. For the new program, FDA worked with OPM to strengthen and validate the matching process, and includes assessment of the suggestions from the final evaluations.
FDA has also strengthened the Learner selection process to ensure that the right people are selected. An Advisor Selection Panel will be made up of OTED program administrator personnel and at least three ORA senior leaders. This panel will review and rate application materials against a set of standardized criteria. They will then convene to make the final selections based on the ratings and the program needs. Additionally, as a long term goal for future cohorts, ORA Senior leaders will be directly involved in the selection process for alumni advisors.
FDA has added five Webinar Learning Panel Discussions with topics ranging from "Political Savvy" to "Developing Others". These developmental panel discussions will be headed by FDA retirees/alumni, giving the current managerial workforce additional organizational awareness and increased learning in MLDP competencies. FDA continues to finalize improvements to the framework for the program, including a clear selection and evaluation process.
The FDA Alumni Association is very proud of this collaboration with FDA and considers this program to be a perfect example of how FDA alumni and active FDAers can work together to further the mission of the agency. Mentors have also experienced great personal satisfaction from sharing their experience and knowledge.
Background: The FDA Alumni Advisor Program (FDAAAP) is an in-depth mentoring program created by ORA in partnership with the FDA Alumni Association. The program pairs retired FDA Alumni (Advisors) with current ORA managers and supervisors (Learners) and focuses on leadership competencies for career development. The voluntary pilot program was approved for six months and began in June 2015. Due to the overwhelmingly positive response from both Advisors and Learners, the program was granted a three month extension and concluded in March 2016. The pilot included 24 ORA managers and supervisors, and 12 rehired annuitants, and due to the success, many of these mentoring relationships were allowed to continue past the formal close of the pilot.
The mentoring relationships were facilitated using the Open Learning Network (ORA's web based learning environment), Microsoft Lync, and the telephone.
Program Overview: 80% of the Learners and 100% of the Advisors responded to numerous beginning, mid-point, and program-end evaluations. The evaluation questions were rated on a 6 - point scale ranging from Strongly Disagree to Strongly Agree. The evaluations covered the following seven topics:
- Skill Level
- Effectiveness of Mentoring Relationships
- Transfer of Institutional Knowledge
- Organizational Satisfaction
- Value of the FDA Alumni Advisor Program
- Developmental Activities
- Recommendations for Program Improvement
Overall, the program pilot was a success and provided growth opportunities for current ORA Managers and Supervisors. The program consisted of regular check-in meetings between Advisors and Learners with all mentoring relationships lasting the entirety of the program (some even wanted to extend beyond). The program matched Learners based on leadership competencies they wanted to learn from Advisors. This unique mentoring opportunity offered individual and differentiated mentoring, which, from Learners' feedback, is one of the success factors. In order to strengthen the results as stated in this final report, OTED has sought feedback from the Advisors and assistance from the Office of Personnel Management to identify opportunities for program improvement, specifically identifying a more robust and valid selection and evaluation process.
Current employees of the FDA may join the FDAAA as associate members, and FDAAA has an active recruitment effort underway to encourage current employees to join. On June 26, at the White Oak campus, current FDAers and FDAAA associate members Laurie Lenkel and Andrea Chamblee reached out to potential associate members with a Meet and Greet which included an introduction to FDAAA and the associate membership. About a dozen attendees came for coffee and bagels.
Two new FDAAA associate members commended the Spring Fling, and told other attendees that they enjoyed the chance to hear and meet the new FDA Commissioner, Scott Gottlieb. As the group convened, they began to brainstorm about roles and advantages for associate members who work in White Oak. Whether they plan to stay at FDA just a few years or until they are eligible for retirement, they agreed that there was a need for resources they could tap for navigating their careers in FDA, to position themselves to be more valuable after they leave FDA.
Laurie and Andrea told them about the FDAAA event, "What I wish I knew," where well-respected FDA retirees presented their advice to new- and mid-career FDA employees, and about the pilot mentoring program with FDA/ORA and FDAAA. They hoped the programs would be repeated, and asked about less formal meetings and mentorships with associate members and all FDAAA members to help them manage their careers.
For membership information, click on the Membership page. Dues for associate members are $20 for 1 year; $35 for 2 years, or $50 for 3 years. A lifetime membership is available for a one-time fee of $300.
On June 9, FDAAA hosted its 8th annual Commissioner's Spring Fling to celebrate the new FDA Commissioner Dr. Scott Gottlieb and former Acting Commissioner Dr. Steve Ostroff. The turn out was terrific from both the alumni and not-yet alumni sides. We enjoyed more than 65 attendees.
The camaraderie around this event is palpable and the Red Hot and Blue BBQ (and vegetarian wraps) were delicious.
Dr. Gottlieb informally addressed the group, highlighting his priorities for the agency and his experiences previously at FDA and on the alumni fronts. He discussed his focus on addressing the opioid crisis and spurring competition in the pharmaceutical marketplace. He also noted that, in the decade he had been away from the FDA, the agency had received major new legislative mandates in both the food (FSMA) and drug (Cures Act) arenas. He noted he was enthusiastic about taking on these challenges and advancing FDA as a strong, science-based agency.
Clearly this is a tradition worth continuing!
On May 11 Dr. Gottlieb became the FDA Commissioner. Here is how the FDA web site (https://www.fda.gov/AboutFDA/CentersOffices/ucm557569.htm) announced his arrival:
"Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. Dr. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA's Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner."
"He also worked on implementation of the Medicare drug benefit as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services, where he supported policy work on quality improvement and the agency's coverage process, particularly as it related to new medical technologies."
"In 2013 Dr. Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on healthcare information technology."
"Dr. Gottlieb was previously a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine as a hospitalist physician."
"He completed a residency in internal medicine at the Mount Sinai Medical Center in New York, New York and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Middletown, Connecticut, where he studied Economics."
Dr. Margaret (Peggy) Hamburg is this year's recipient of the Harvey W. Wiley Lecture Award. Dr. Wiley, as we all know, was the first FDA Commissioner, after he navigated through Congress the enactment of the original Pure Food and Drugs Act which led to the creation of the FDA. Dr. Hamburg served as Commissioner under President Obama. She expanded FDA's global presence and established many of the programs recently added to the agency. In this photo Dr. Hamburg accepts the award from Ed Steele, who has served as president of FDAAA since 2013 and who is this year's recipient of the FDA Distinguished Alumni Award. Dr. Hamburg delivered the annual Wiley lecture on May 5 at the Food and Drug Law Institute's annual meeting in Washington, D.C. Dr. Hamburg also was recognized at the FDAAA annual meeting which was held the same day. For background on the awards please see the Awards page.
FDAAA each year sponsors an afternoon session for the FDA Fellows Class. The session consisted this year of a presentation by FDA Historian Suzanne Junod, followed by a session where FDA alumni discuss their experiences at FDA and the lessons they learned. The alumni who participate come from many different offices across the agency to give the Fellows a broad series of insights into the agency.
Seven alumni/FDAAA members participated in the session on January 23 at the White Oak building. See the photo for the alumni presenters.
Some of the themes underscored by the alumni were to advise the Fellows to take advantage of the unique opportunities presented by the FDA, and what specific steps the FDA Fellows can take to maximize their experience at FDA.
This is the eighth year that the FDAAA has sponsored this briefing. Many Fellows have turned into permanent FDA employees.
Recent FDAAA Events
- FDAAA Sponsors FDA Fellows Session (2/10/18)
- West Coast Networking Event (2/1/18)
- FDAAA's Winter Luncheon Featuring Peter Marks, M.D., Ph.D. (1/20/18)
- A Winter Celebration (12/14/17)
- Eastern Shore Informal Gathering (7/23/17)
- FDAAA Meets and Greets Current Employees (6/26/17)
- Another Successful Spring Fling (6/22/17)
- Dr. Scott Gottlieb is New FDA Commissioner (5/12/17)
- Dr. Hamburg Receives FDAAA's Wiley Award (5/11/17)
- FDAAA Briefs FDA Fellows Class on FDA History, Perspective (1/24/17)
- FDAAA Luncheon on West Coast, A Huge Success (1/18/17)
- FDA and FDAAA Refresh MOU after 13 years (12/13/16)
- FDAAA's Hail to the Chief Counsels and Their Deputies a Resounding Success (12/12/16)
- Hail to the Chief Counsels (12/09/16)
- FDAAA Midwest Inaugural Luncheon Held in Chicago (12/09/16)
- In Memorium: Ekopimo Ibia, M.D., M.P.H., MRCPCH, FWACP (Peds), FRCP (06/27/16)
- Spring Fling! (05/23/16)
- FDAAA Honors Three Leaders (05/23/16)
- FDAAA Members Are Updated on Combination Products (04/12/16)
- FDA Alumni Advisor Program a Big Success (03/25/16)
- FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices (02/20/16)
- FDAAA Conducts Seminar for FDA Fellows (01/09/16)
- Reception for Chiefs of Staff (12/10/15)
- Luncheon November 6, 2015 (11/06/15)
- FDAAA International Network visits with CFDA Officials and BioBAY Entrepreneurs (08/03/15)
- Dr. Florence Houn Receives DIA China Excellence in Service Award (08/03/15)
- FDAAA International Network Expands Footprint at 2015 DIA China Annual Conference in Shanghai China (08/03/15)
- FDAAA International Network hosts an "FDAAA and Friends Night" event in Shanghai (08/03/15)
- FDAAA International Network Featured at 51st Annual DIA Meeting (08/01/15)
- Andrew Bonanno Receives FDA Distinguished Alumni Award (06/29/15)
- Michael Taylor Receives FDAAA Wiley Award (06/28/15)
- FDAAA Launches New Year at Annual Meeting (04/20/15)
- FDAAA Elects New Board Members, Names Officers (04/20/15)
- FDAAA Luncheon with FDA CDER Center Director, Janet Woodcock, MD, April 2, 2015 (04/10/15)
- NEW FDA Alumni Mentor Program to Begin in the Fall! (8/31/17)
- FDA Celebrates 40th Anniversary of Medical Devices Amendments (06/21/16)
- FDA Seeking "Objective" Reviewers for Grant Funding (04/19/16)
- Vacancy Announcements for Key Alumni Association Positions (12/18/15)
- FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program (04/17/15)
- Opportunity: RAPS Seeks Regulatory Experts (03/10/15)
- FDAAA Praises Hamburg for Her Dedication To FDA's Mission and Looks Forward to Working with Dr. Stephen Ostroff Who Will Serve as Acting Commissioner (02/05/15)