When I look back to my years at FDA, I think of my dedicated and hard working colleagues, and I clearly remember the unanimity of our mission. Working every day to do what was in the best interests of public health brought so many of us a great sense of purpose and significant professional satisfaction.
I spent close to 12 years at FDA, serving as Deputy Commissioner for Global Regulatory Operations and Policy and as Director of the CDER Office of Compliance. For seven years before that, I was a Trial Attorney at the U.S. Department of Justice, where I brought civil and criminal enforcement cases for FDA and also defended FDA in court. Since leaving FDA for the pharmaceutical industry in 2013, I am pleased to say that I have always been able to work in the best interests of patients and to continue my focus on improving public health.
That said, my time at FDA has been the best chapter of my professional life so far. This is one of the reasons that I spend so much time working for the FDAAA, and I am honored to be Chair of the Board. The goal of FDAAA is “Serving Those Who Served.” Through FDAAA, I am able to help to support the agency, its mission, and its employees. After all, as we like to say, “Once an FDAer, always an FDAer.”
Obviously, COVID is a massive challenge currently facing FDA. I can imagine the round-the-clock efforts of so many at the agency, knowing that the faster they can work, the more people they can help with vaccines, therapies, test kits, and so much more. As a patient, I am deeply grateful for these efforts. I am comforted by knowing that FDA is using its expertise and best judgment every day to help to combat the pandemic.
The Alumni Association has worked hard to send its thanks and support to FDA during the pandemic in many ways, including by video and letter. Since our members have filled so many of the shoes at FDA, we know that an FDAer’s job can be a thankless one. Despite all of its best efforts, the agency often gets far more criticism than praise. All of us deserve both sometimes, but people seem far more willing to criticize FDA than to express the appreciation that the agency richly deserves for all it does. We hope that FDAAA can be a beacon of encouragement to the agency when needed.
Thank you to the many volunteers who make up FDAAA. We have many dedicated Officers, Directors, Committee Chairs and Co-Chairs, Committee Members, and Members who put in countless hours in support of FDAAA. And, thanks from all of us to all of you at FDA for all you do!