Pursuing a Path With the FDA

AUGUST 01, 2018
Shanice Anderson, PharmD Candidate
As a pharmacy student in Washington DC, I have had the privilege of being exposed to a number of opportunities available for pharmacists who wish to work in the federal government. All these options offer exciting rewards and challenges to future pharmacists, but a path that I have found to be particularly appealing is a career with the FDA.

Pharmacists who work for the FDA are largely responsible for overseeing the long and complex process that pharmaceutical companies and researchers must undergo to gain approval for a new drug. The approval process is broken down into various stages, from molecule to medicine, and the agency works to enforce the regulations that ensure drugs, medical devices, and similar products are safe and effective for use in the intended population.

Key roles within the FDA oversee each step, such as investigational new drug (IND) application reviewers and new drug application (NDA) reviewers. An IND application presents all evidence and research showing a drug is safe enough to be tested in human patients during the clinical trial phase; in contrast, an NDA must be submitted to the FDA by pharmaceutical companies and researchers at the end of clinical trials for approval and subsequent sale and marketing in the United States. These documents must be approved in their entirety for drug development to continue to the next stage.

A pharmacist’s training as a “drug expert” is extremely useful in many different offices within the FDA. One office might deal with bringing new drugs to market, whereas another might inspect regulated products that have already launched. Pharmacists also can put their skills and knowledge to use in the Office of the Commissioner, which serves as a liaison between the FDA and legislative entities and leads scientific activities and health initiatives, and the Office of Medical Products and Tobacco, which houses several other important offices, such as the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, and the Center for Drug Evaluation and Research. The spaces that a pharmacist can occupy within the FDA are vast, and the expertise that pharmacists bring to the agency enable them to succeed in almost any role, including positions not intended specifically for pharmacists.

It is not uncommon for a pharmacist to transition from a career in clinical, community, or industry practice to one within the FDA. Many of the skills required by and gained from working in these settings are translatable to the tasks carried out by the FDA. For example, working in regulatory affairs for a pharmaceutical company is extremely similar to working for the FDA, with the nuance being that industry regulatory affairs personnel ensure that the regulations of health authorities, including the FDA, are met. In addition, many FDA pharmacists are commissioned officers in the United States Public Health Service.

Working for the FDA offers a unique experience that can be extremely rewarding. Even though that career path does not focus on direct patient care, the work that pharmacists do in this capacity helps improve the quality of medications and medical devices and, thus, has a great effect on patient health.
 
Shanice Anderson is a 2020 PharmD candidate at the Howard University College of Pharmacy in Washington, DC.

 

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