"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"

Email addresses: Please be sure FDAAA has your current email address. Please check the directory on this web site to make sure. If your email address is outdated, or if you do not receive periodic FDAAA Updates from Alan Andersen, please let Karen Carson know. (kdlmc@aol.com)

Winter Luncheon

Please join your friends and colleagues at the FDA Alumni Association’s winter luncheon featuring Peter Marks, M.D., Ph.D. Director, Center for Biologics Evaluation and Research for a discussion of new developments in CBER and the emerging technologies that it regulates.

Friday, January 19, 2018 from 12:00 – 2:00 PM

Mrs. K’S Tollhouse
9201 Colesville Road
Silver Spring, Maryland

$45 per person

Please RSVP by January 12, 2018 to rsvp.fdaaa@gmail.com

Payments can be made directly via PayPal (select “Pay with Debit or Credit Card” to checkout as a guest)

A Winter Celebration

This year, in San Francisco, we honored FDA Associate Commissioners for Regulatory Affairs (all those ACRAs over the years) and FDA Deputy Commissioners for Global Regulatory Operations and Policy.

Winter Celebration

Our Winter Celebration was generously hosted at Hogan Lovells. Thank you, Joe Levitt!

Winter Celebration

Nancy Myers provides remarks to the crowd

Winter Celebration

Guests mingle at the Winter Celebration.
[I know Nancy Myers is in the middle, Deb Autor is next to her, and Julia Luan is on the far right]

Winter Celebration

A great time was had by all at FDAAA's Winter Celebration honoring past Associate Commissioners for Regulatory Affairs and Deputy Commissioners for Global Regulatory Operations and Policy. Pictured from left: Joe Levitt, Lisa Barclay, honoree John Taylor III, honoree Deb Autor, honoree Howard Sklamberg, honoree Ron Chesemore, and Nancy Myers.

A Winter Celebration - Monday, December 4, 2017

This year we are honoring FDA Associate Commissioners for Regulatory Affairs (all those ACRAs over the years) and FDA Deputy Commissioners for Global Regulatory Operations and Policy.

This promises to be a great event. As in past years, there will be no charge for this event.

Alumni and associate members, spouses and special guests are welcome. The FDAAA Board of Directors will meet that same day just before this free reception, and, since they will likely stick around, you will have a chance to meet and greet our organizational leaders.

And did I mention that it is free!

When: Monday, December 4 from 5:30 to 7:30 pm

Where: at Hogan Lovells, 555 13th Street, NW, Washington, DC

Because this is a secure facility, we need to put your name on the list for you to gain entry. And time is getting short. Therefore, we need you to RSVP to your invitation!

Contact Lisa Barclay at LBarclay@BSFLLP.com to get on the list.

We do have sponsors lined up (that is why it is free), but if you, your firm, or your organization is interested in sponsoring the event, please let Lisa Barclay know at LBarclay@BSFLLP.com

Platinum, Gold, and Silver Sponsorship Levels are available (contact Lisa for details). FDAAA is a 510(c)(4) organization, and any donation is tax deductible.

Join Us for the FDA Alumni Association's 2nd Annual West Coast Networking Event

  • Sunday, January 7th 4-6 pm
  • S&R Lounge at Hotel Zetta
    55 5th Street
    San Francisco, CA
  • Corporate sponsorships welcome
  • RSVP to FDAAAWestCoast@gmail.com

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 blake.bevill@fda.hhs.gov

NEW FDA Alumni Mentor Program to Begin in the Fall!

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.

Denise Collins

Denise Collins, an FDA Alumni Association Member, is the program manager for the FDA Alumni Advisor Program and is a Management Analyst and Training Officer in Leadership, Management & Administrative Training, Office of Training, Education & Development, Office of Regulatory Affairs, Food & Drug Administration.

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.

Eastern Shore Informal Gathering

Eastern Shore Meet Up

FDAAA members and friends who spend weekends on the Eastern Shore of Maryland gathered for lunch July 20 to celebrate summer and reminisce about their days at the agency. FDAAA encourages alumni to hold such informal gatherings.

FDAAA Meets and Greets Current Employees

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.

June Meet and Greet

Current FDA employees learn about FDAAA at the Meet and Greet June 26 at White Oak

Another Successful Spring Fling

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!

Gottlieb at Spring Fling

New Commissioner Gottlieb addresses the Spring Fling

Ed Steele and Susan Mayne

FDAAA President Ed Steele and CFSAN Director Susan Mayne

65 People attended the Spring Fling

About 65 people - alumni and future alumni (i.e., current employees) attended the Spring Fling

Dr. Scott Gottlieb is New FDA Commissioner

Scott Gottlieb, M.D.

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. Hamburg Receives FDAAA's Wiley Award

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 Briefs FDA Fellows Class on FDA History, Perspective

FDAAA members and FDA alumni brief the FDA Fellows. Left to right are Bill Vodra, Susan Winckler, Jeanne Ireland, Debbie Henderson, Nancy Myers, Ed Steele and Wayne Pines

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.

Links to Recent FDAAA Events and Announcements

Recent FDAAA Events