CHSU Pharmacy Student Completes Competitive FDA Clinical Rotation

CHSU Pharmacy Student Completes Competitive FDA Clinical Rotation

CHSU College of Pharmacy fourth year student, Dolly Mehta, was ecstatic when she got the news that she was accepted for a highly competitive pharmacy rotation with the U.S. Food and Drug Administration (FDA) for Fall 2020. This particular rotation receives over 800 applications and takes only two students a year on average. Just a week prior, she was notified that the FDA rotation application cycle had ended and no one was selected. But a few days before spring break, she received an email from her preceptor inviting her for a 6-week rotation at the FDA that would be completed virtually due to the COVID-19 pandemic.

In September, Mehta was assigned to the FDA’s Center of Drug Evaluation and Research Department (CDER) under the Office of New Drugs (OND). She specifically worked under a preceptor in the Division of Urology, Obstetrics, and Gynecology (DUOG) where they evaluated drug application requests related to medications that treat these body systems like contraceptives, prostate treatments, and gender dysphoria treatment/management medications.

Her rotation focused on the project management aspects of the drug approval process for drugs that are new molecular entities or existing drugs can be used for another application. She participated in meetings with drug sponsors who were in the application process of bringing their drug to market. Under her preceptor, she was part of an interdisciplinary team (including chemists, pharmacologists, toxicologists, bio statisticians, clinical staff, and doctors) assigned to evaluate drug applications.

“I was interested in the regulatory processes and I wanted to learn more about why things are done the way they are. Medications are so readily available in other countries, so I wanted to see what the process is in America and why it takes so long to approve new medications,” said Mehta.

Drugs go through a rigorous testing and approval process before they can be used to treat patients. It costs drug-makers more than $2 billion dollars to bring a drug to market.[1] The planning and approval process is arduous to ensure patient safety and efficacy.

“It all comes down to public safety. We are giving back to the consumer on such a large scale. In other pharmacy settings we may only help a handful of patients each day, but here we are helping thousands of patients a day,” said Mehta.

And although she would have enjoyed working on-site with the FDA in Maryland, if it weren’t for COVID-19, Mehta says that she still gained a lot from the experience. It made her realize that it wasn’t always necessary for pharmacists working in this capacity to actually be physically present.

“With COVID, it’s made us realize that working remotely is a lot easier than we had ever imagined. Unless you’re meeting with a drug sponsor in person, most of the work can be done remotely. It was an eye opener,” said Mehta.

Mehta has completed her rotation with the FDA and is continuing her studies with CHSU. She will be graduating in Spring of 2021 with hopes to stay in the Central Valley to practice.

 


[1] DiMasi, Joseph A., et al. “Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs.” Journal of Health Economics, North-Holland, 12 Feb. 2016, www.sciencedirect.com/science/article/abs/pii/S0167629616000291?via=ihub.