FDA rotation offers student unique experience
Professional student pharmacists learn more about the profession and gain valuable hands-on experience by participating in rotations that focus on specific areas in pharmacy.
Andrew Himsel, a fourth-year professional student pharmacist at the Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy, recently completed a rotation with the Food and Drug Administration.
The student experiential program at the FDA emphasizes a well-rounded experience for students like Himsel and gives them the opportunity to learn about programs and offices within the FDA, such as the Drug Shortage Program, Office of Compliance and the Division of Pharmacovigiliance. Students also have an opportunity to learn about the Center for Drug Evaluation and Research (CDER), a program that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
“The FDA rotation was vastly different from the others that I have had the opportunity to take part in,” Himsel said, who is from Baytown, Texas. “This rotation was largely based on regulatory issues, which is quite different from the clinical or operational rotations that I have had and will do in Texas. There are not a lot regulatory opportunities in Texas, so I was very thankful to get the opportunity to rotate at the FDA.”
On average, 10-15 students from all over the United States rotate through this program every five to six weeks. This provided Himsel with a great opportunity to work along with fellow students who bring with them varying educational backgrounds and pharmacy experiences.
“The FDA rotation is open to student pharmacists from schools nationwide, and has a highly competitive process for student selection,” said David Matthews, Pharm.D., director of the Advanced Pharmacy Practice Experiences at the Texas A&M Rangel College of Pharmacy. “The college has had students apply for this rotation previously, but Mr. Himsel is our first student to be offered this highly coveted slot.”
The students are grouped into divisions and offices at the FDA where they work on current FDA projects with their preceptor, an expert that guides the students during their rotation.
Himsel was assigned to the Office of Drug Information where he was able to work on the President’s Emergency Plan for AIDS Relief (PEPFAR) project—a $15 billion initiative put into place under former President George W. Bush in 2003. This particular project ensured that the drug information packaged with anti-retroviral treatments received from drug manufactures from around the world, even those not FDA approved, were in compliance with FDA labeling requirements.
Other rotation experiences that Himsel took part in included attending lectures and assisting patients on the MedWatch phone system.
The lectures he attended were at various divisions within the FDA as well as organizations such as American Society of Health-System Pharmacists and American Pharmacists Association.
“It was through these lectures that I really began to understand how the medication approval process and post-marketing surveillance programs really worked,” Himsel said. “It was truly eye-opening to see how meticulous each part of the drug approval process was and how many resources drug applications consume from both the manufacture and the FDA.”
While working in the MedWatch phone center—a reporting hotline for patients who have suffered an adverse drug event—Himsel was able to quickly access drug information from the FDA’s resources and effectively interpret and communicate it back to the patient.
He was able to provide information on adverse drug events and also general information for patients requesting more information on their drug therapies.
Himsel said he learned that there is an enormity of resources used to regulate drugs in the U.S. Experiencing parts of the drug approval process and post-marketing surveillance measures allowed Himsel to experience processes that he could not experience in any other rotation.
“I would absolutely recommend this rotation to students who are interested in learning more about regulatory affairs,” Himsel said. “It was a unique experience that I will likely never have the opportunity to do again and I am thankful that I did it.”
Story written by Art Niño, senior English major at Texas A&M University-Kingsville.