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An Interview with an FDA Preceptor: Pharmacist’s Role at the FDA

By: Melissa Roy Co-Copy Editor [Graphics focused]

Our dedicated preceptor Kimberly Defronzo, RPh, MS, MBA is currently a Consumer Safety Officer at the Food and Drug Administration (FDA). She attended the University of Connecticut School of Pharmacy for her Bachelors of Pharmacy. She then went to St. John’s University College of Pharmacy and Health Sciences to obtain her Masters in Industrial Pharmacy and later received an MBA in Marketing from Rutgers University Graduate School of Management.  She is currently a Consumer Safety Officer but has worked as a Reviewer for the FDA approving/rejecting proposed proprietary/trade/brand names of drug products. Prior to joining the FDA, she held various positions in retail, hospital, and pharmaceutical settings. Her journey as a pharmacist has been unique and unconventional.

As an APPE preceptor for St. John’s PharmD students, she finds great joy in being able to provide students with the opportunity to learn about the FDA. She strives to provide an enjoyable and educational environment for her students while focusing on their professional and personal development. Through her dedication, students are given the opportunity to experience this unique rotation where they are able to witness the FDA at work. A rotation at the FDA will expose students to the possibility of yet another rewarding career path for pharmacists. Our interview with her provided us with an insight and appreciation of how interesting it is to be a pharmacist at the FDA.


As the Consumer Safety Officer at the FDA, what does a typical day entail (or what is an unique experience that you had)?

The role of a Consumer Safety Officer is a complex and diverse one.  There is no “typical” day as each day brings unexpected challenges and issues to address.  One moment I can be assisting a physician trying to obtain an unapproved drug to treat a dying patient while the next moment I can be helping a manufacturer bring a drug to market.  Each interaction is unique since there are nuances to every situation even if it may appears to be similar at the onset.  The job is extremely demanding since it requires broad and extensive knowledge of FDA regulations as well as its policies and procedures regarding disclosure of the information.  The job may be stressful but it also brings unlimited intrinsic rewards since we are in a very privileged position of being able to help someone that has exhausted all other channels.


What did being a Reviewer for the FDA entail?

The role of a Reviewer is very different since it has a very narrow focus.  When you are a     Reviewer, you are responsible for reviewing only one specific area within your field of expertise.  You are considered the subject matter expert (SME) for that area and your review work involves evaluating and assessing one particular section of the new drug application (NDA) or abbreviated new drug application (ANDA).  Each drug application is divided into numerous sections and each subsection is assigned to the SME(s) for review and approval or rejection.  The FDA implemented the “Equal Voice” initiative to ensure that, regardless of where the signatory authority resides, decisions are made only after all appropriate expertise is brought to bear.  Equal Voice Initiative applies to the review of all product applications. It’s an operational philosophy and set of practices to ensure that each professional viewpoint has been fully expressed, understood, and brought into the decision-making process. When there is disagreement among a review team, each discipline must voice its concerns. This process engages the entire team in scientific debate and brings each viewpoint into discussion so that a decision can be made at the team level. It doesn’t mean that everyone necessarily agrees with the decision, but it ensures that all scientific and regulatory experts have input before a decision is made. The rewards of being a Reviewer comes from the fact that you are an integral contributor of the overall approval or rejection decision of a drug application.


How was one unique way that your school helped you pursue your current career path?

I strongly feel the school you select plays a crucial role in shaping your future career paths.  I was very influenced by the UConn’s research-based philosophy and consequently pursued my graduate studies in the pharmacy research and development field due to my professors’ encouragement.  I subsequently selected St. John’s due to its unique offering of the “Industrial Pharmacy” program since I wanted to explore a career as a researcher at a pharmaceutical company.  However, while working on my Master’s thesis, I realized I did not enjoy spending countless hours in a laboratory setting so R&D was not a good fit for my personality.  Therefore, I further pursued and graduated with an MBA in marketing from nearby Rutgers University.  This business degree provided me with a different insight to help me succeed in roles that are outside of the traditional pharmacy pathway of retail or hospital.


In your opinion, what course was the most beneficial towards your career and why? 

It is difficult to select only one course that was the most beneficial towards my career as a pharmacist since it was a combination of many different courses that provided the sufficient knowledge to function as a pharmacist.  In order to perform all of the vast responsibilities required for the role of a pharmacist, it is important to be well versed in medicinal chemistry, pharmacology, pharmacokinetics, pharmaceutics, to name a few.  (Sorry to my math professor that calculus did not make my list!)


What organizations were you a member of during school; did they play any role in the career you chose to pursue?

I was in Rho Chi, however, I do not feel it contributed to any major decisions in my career choices.


Why did you decide to pursue an unconventional career path, if you could go back and start over again would you pick a different path?

I love being a pharmacist but did not enjoy being in R&D so that might be the one path I would change in hindsight.


What is the best aspect of your current job?

The ability to help people that are unable to obtain assistance anywhere else since most people tends to seek assistance from the FDA as their last resort.  Therefore, the intrinsic reward from being able to help someone that has exhausted all their resources or who is in desperate need of the higher powers of the government to step in (e.g., the ability to grant access to life saving treatments) is priceless.


What is the worst aspect of your current job?

The disappointment that comes from not being able to meet the expectation of the requestor since people do not understand the limitations of the authority given to the FDA and how the FDA is strictly bounded by regulations.


Did you have a mentor? How did they help your career? If not, what is your opinion of mentors?

I was fortunate enough to have had a number of great mentors throughout my career starting with college professors, preceptors at internships/externships, and bosses at work.  Having a great mentor is critical to the success of the student throughout his or her academic career and beyond.  Everyone should try to place themselves in the student’s position and/or try to remember back to a time when they themselves were in need of a helping hand and how important it was to be the recipient of that helping hand.


What is one piece of advice you would provide future pharmacists as they begin to look at various career options?

We are very fortunate to be pharmacists in this current market since the field of pharmacy offers us limitless opportunities and career choices.  I highly suggest all students explore residencies or fellowships after graduation so that they can learn at a more in-depth level how best to match the many career choices to their personal interest and aspirations.

The Rho Chi Post wants to thank Kimberly Defronzo for sharing her time and expertise with us. We hope that this interview highlights potential career paths for our future pharmacists.

[pubmed_related keyword1=”FDA” keyword2=”career” keyword3=”pharmacist”]

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