Why Should You Consider a Career at the FDA?March 2, 2015 at 12:12 am
Considering the next steps in your career? In this column, three physicians from the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP), within the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration, discuss their current roles, professional backgrounds, and why this work is rewarding. DPARP regulates drugs and biologic products intended for the prevention, treatment, or diagnosis of respiratory system diseases, allergy and immunologic diseases, and rheumatologic diseases.
What do you do at the FDA?
Badrul Chowdhury, MD, PhD: As director, I oversee the scientific and administrative work of all DPARP staff and provide overall leadership for DPARP.
Anthony Durmowicz, MD: As lead medical officer, I oversee several medical officers and serve as the team leader for new drug and biologics applications. In this role, I coordinate the review of applications across all the relevant review teams, summarize available data, and recommend whether to approve an application or not.
Sally Seymour, MD: As deputy director for safety, I provide oversight and coordinate post-marketing safety activities in DPARP, including post-marketing safety issues, safety labeling changes, and post-marketing studies and trials.
What path led you to the FDA?
Dr. Chowdhury: I completed a PhD in immunology and a fellowship in allergy and immunology at the National Institutes of Health. Then, I pursued an academic research career at the University of Tennessee for two years and joined the FDA in 1997.
Dr. Durmowicz: Following my pediatric residency and fellowships in pediatric pulmonology and critical care at the University of Colorado, I pursued an academic research career at the University of Colorado, University of Utah, and Washington University. When I stopped pursuing a research career, I looked into drug development opportunities, which led to a position in the biotech industry and then the FDA in 2005.
Dr. Seymour: I joined the FDA in 2003 as a medical officer after completing my pulmonary and critical care fellowship at the University of Cincinnati.
What is most rewarding about your work at the FDA?
Chowdhury: Being able to influence public health. We make regulatory decisions in various disease areas that affect a large number of patients and health care providers.
Durmowicz: We help patients by approving important medications as well as not approving drugs that don’t work or are unsafe. In addition, it is very important for me to work in an intellectually challenging environment with people I respect, can learn from, and enjoy working with. I have found that here.
Seymour: In addition to the effect on public health, the work environment is rewarding. Our multidisciplinary team approach facilitates interaction and learning. In addition to over 20 medical officers in DPARP, we also work with pharmacologists, toxicologists, chemists, and statisticians, and I am constantly learning from my colleagues.
Why should fellows and trainees consider a career with the FDA?
Chowdhury: The medical officer position requires the skills of a clinician, critical thinking, and an investigative scientific mind. Many clinicians coming out of fellowship have such attributes and can pursue a career at FDA. The FDA work environment is also highly rewarding, provides a stable and well-defined career path with growth potential, and is accommodating to personal and professional needs.
Durmowicz: The medical officer position provides for an alternative science and public health career. We need astute, critically thinking pulmonary and critical care physicians for two reasons: to be able to provide the best advice to companies wishing to develop drugs to treat pulmonary diseases and to review the clinical data obtained from pulmonary drug development programs.
Seymour: The medical officer position provides an opportunity to learn about drug development, clinical trial design, and analysis of efficacy and safety data. You gain insight into what we as a medical community do and do not know about drugs when they are approved. It is critical that we have reviewers with pulmonary training to understand the diseases and development programs given the impact our decisions have on patients and practitioners.