Tuesday, April 7, 2015

Nontraditional Paths: Rotation 4 at the FDA

Posted by Unknown at Tuesday, April 07, 2015

I was only at the Food & Drug Administration (FDA) for five weeks, but I learned and experienced more than I could have imagined during this block.

I spent my time in the Office of Compliance within the Center for Drug Evaluation and Research (CDER). The majority of my time was focused on projects involving drug compounding regulations, counterfeit drug legislation, and review of unapproved drug listings within the FDA's database. These projects allowed me to get involved in areas of pharmacy practice that I had never encountered before, and it was amazing to see the rationale and work that the FDA does to ensure that patient safety is a priority.

Aside from these projects, the FDA sets up numerous topic discussions with different offices so you can gain a sense of the responsibilities of pharmacists in a number of settings - Pharmacology, Orphan Drugs, Medical Policy, New Drugs, Regulatory Policy...the possibilities are endless. In addition to these coordinated discussions, there were a number of opportunities to visit different organizations in the DC area. I was able to go on tours of the APhA Headquarters, the NIH, and the Pentagon during my time there with relative ease as we had already undergone background checks through the FDA.

I was also able to attend a number of presentations that the FDA offered both onsite and off-campus around Silver Spring. Many focused on initiatives in drug development, which is my personal area of interest, so it was amazing to be able to sit in on these events and listen to expert discussions on new research and what areas were still in need of improvement. The most amazing experience I had, by far, was the morning that I attended a congressional hearing on incentivizing industry to develop therapies aimed at addressing antibiotic resistance (pictured). I was able to listen to key industry leaders, members of the Energy & Commerce Committee, and Janet Woodcock, the CDER Director at the FDA, engage in discussions about how best to tackle this issue. If you are interested in how the discussion went, you can check it our more here. I would highly recommend attending a hearing if you find yourself on this rotation with the opportunity to go.


Finally, use this opportunity as a chance to explore the DC area. There are TONS of museums, restaurants, bars, festivals...really anything you could want to do, you will be able to find a place to do it there. I highly recommend putting together a bucket list of places to go and things to do, and try to time some tours with when you will be there. My rotation was certainly busy between rotation itself and adventuring around DC, but it was completely worth it in hindsight.