Ever wonder what role physician regulators—rheumatologists, in particular—perform at the U.S. Food & Drug Administration (FDA)?
“I am not sure that many practicing rheumatologists know there are clinicians who work for the FDA,” says rheumatologist Nadia Habal, MD, a medical officer in the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA. “It would be nice for them to know that we have an essential role here in many capacities.”
Reviewing New Drugs
Clinicians review and evaluate new and investigational drugs, as well as associated submissions, such as clinical study protocols and their amendments, safety reports and labeling supplements.
These physicians also provide regular updates and recommendations to clinical reviewer team leaders on an assigned portfolio of regulatory submissions, analyze and summarize clinical trial data submitted by industry or individual investigators during the review of regulatory submissions, conduct literature searches and compile data to prepare reports related to the work of the division, and develop background data pertinent for FDA programs, among other duties.
Impact on Patients
“As a physician, you see firsthand how medications impact patients,” Dr. Habal says, referring to the need to ensure necessary lab tests for screening and maintenance are performed, to recognize potential barriers to taking a drug, including dose, frequency, method of delivery and side effect profiles, and to assist with insurance approval for the expensive drugs used to treat rheumatologic conditions. With these insights, the role physicians play at the FDA can make a big difference in patients’ lives.
Nikolay P. Nikolov, MD, medical office team leader at the FDA, views his role as a regulator as similar to that of being a physician in practice. As a regulator, however, he says, “I assess the benefits and potential risks of new therapies to the population of patients rather than to an individual patient.”
A board-certified internist and rheumatologist, Dr. Nikolov is also associate director for rheumatology in the Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER), as well as the division’s transition lead for the soon-to-be-formed Division of Rheumatology and Transplant Medicine, as part of the ongoing Office of New Drugs’ (OND’s) reorganization.
After completing an internal medicine residency at Lincoln Medical Center, the Bronx, N.Y., in 2002, Dr. Nikolov joined the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health, where he completed his rheumatology fellowship in 2004, participated in clinical investigational protocols and studied cellular and molecular mechanisms of autoimmunity in animal models in the Immunoregulatory Group, Autoimmunity Branch at NIAMS.
“I first learned about the opportunity to work as a clinician at the FDA from a colleague, a one-year senior NIH co-fellow, who moved from NIH to the FDA as a medical officer,” he says. “Subsequently, several of my co-fellows also moved from the NIH to work for the FDA.” Dr. Nikolov joined the FDA himself in 2009 as a medical officer.
