Beyond the Classroom: Practice Experience at the FDA

Touro College of Pharmacy Students Learn About Drug Development, Approval and Safety at the Food and Drug Administration

April 08, 2024
pharmacy student standing outdoors in plaza in front of large government building
Dorina Birce at the FDA

Fourth-year Touro College of Pharmacy (TCOP) student Dorina Birce had an opportunity that many of her peers -- especially those interested in public health -- would yearn for: a chance to rotate at the Food and Drug Administration.

Birce was one of several TCOP students chosen recently by the FDA for an Advanced Pharmacy Practice Experience (“APPE”), a required part of the curriculum for pharmacy students starting in spring of their third year

“I was very excited to be given the opportunity,” said Birce, who is pursuing both a PharmD and a Master of Public Health (M.P.H.) at Touro.

Students go through nine such advanced rotations, offered at hospitals, in industry, at retail pharmacies and at other health care providers, such as the Indian Health Service.

Carrying it Forward

“Throughout my four years at TCOP I’ve learned the significance of adverse events on patients’ overall health outcomes and disease management. I was able to carry this knowledge forward at the FDA,” said Birce.

She was assigned to the Division of Mitigation Assessment and Medication Error Surveillance, part of the Center for Drug Evaluation and Research (CEDR). During her six-week rotation she reviewed and analyzed medication errors and suggested how they could be avoided.

One memorable assignment involved assessing and analyzing product labels and prescribing information for topical medications made by a pharmaceutical company. She analyzed errors that had occurred and ways to avoid them in the future.

As a pharmacist, Birce said she plans to use what she learned to minimize medication errors. These would include, for example, paying close attention to look-alike or sound-alike products and reporting errors when they occur so action can be taken to reduce errors. 

“The rotation was one of the most eye-opening experiences in my pharmacy career. It not only enhanced my love and appreciation for the field of pharmacy but for public health as well,” she said.

Researching, Presenting, Networking

Classmates Ugonna Ogbenta and Angy Ahmed also completed advanced rotations at the FDA at the Office of Bioequivalence, which is part of the Office of Generic Drugs under CEDR.

They had the same rotation and the same preceptor. They researched drug therapies for various disease states and attended a daily lecture series where they learned about clinical trials, the generic drug development process, and the laws and regulations governing drugs.

In their free time they set up networking meetings throughout the divisions to learn about the various roles at the FDA. They also gave presentations to scientific reviewers.

“The rotation provided exposure to the FDA’s critical role in overseeing drug development, approval, manufacturing and safety surveillance,” said Ogbenta. “Presenting allowed me to dive deep into specific therapeutic and regulatory topics, hone my communication skills and gain experience interacting and presenting to regulatory professionals.”

Ahmed researched and presented on a medication intended to reduce the risk of cardiovascular events and another on a diabetes drug aimed at slowing progression of chronic kidney disease (CKD).

The opportunity to give a presentation on the diabetes drug resonated with her, she said, because her uncle had been diagnosed with CKD. Having witnessed his struggles made the topic very personal.

“It was rewarding knowing that the information I was researching could potentially offer hope and improve quality of life for my uncle and other patients,” said Ahmed.

After graduation she plans to work in regulatory affairs at a pharmaceutical company, the direct result of her FDA rotation, which followed an internship at the drug company Endo Pharmaceuticals. There, she researched laws and regulations to help gain approval to market the company’s generic drugs.

“I saw it from the pharmaceutical side but I wanted a different point of view. I loved my time at the FDA. Now that I’ve seen both sides, hopefully I’ll end up at the FDA one day.”