Disclaimer: The opinions expressed within this blog are those of myself exclusively, and does not reflect or represent the current views and thinking of the FDA.
I have heard of a few versions of the acronym for the FDA, including the Federal Drugs Administration and Federal Drugs Association, and some random ones such as Florida Dental Association and Food Development Association.
The correct version is Food and Drug Administration, which means that the Agency does not only focus on drug safety and efficacy alone, but it also includes medical devices, new drugs and generic drug applications, vaccines, blood transfusion, dietary supplements, tobacco products and cosmetics. It even regulates pet products and IVF!
Sounds pretty exciting if you like variety in science, interaction with people from different scientific disciplines and backgrounds, or to be able to have direct dialogue with the company who has filed the application.
Let me backtrack a little and explain how I got to the FDA. I was working as an academic in New Zealand when I saw a job posting from the FDA at the Office of Clinical Pharmacology. From the first contact, excellent and highly professional people helped me set up Skype interviews.
Moreover, it can take over 24 hours to fly from New Zealand to Maryland, USA. The specialist worked closely with me in filing my work visa, and answered all the questions I had. I was offered an ORISE fellowship granted by the Oak Ridge Institute for Science and Education, which allows me to work in the FDA campus on a given project.
The first few weeks were a bit daunting; I had to go through a rigorous background check, detail my history of activities in the last 7 years prior, including travels, work, education and criminal past to name a few.
I have a supervisor and was assigned a primary project to devote my time to. However, there were countless opportunities to expand my regulatory knowledge and exposure to exciting scientific breakthroughs. There were frequent NDA briefings, which is when a New Drug Application is submitted to the Agency. There were open meetings to introduce sponsors, or the company that submitted the NDA application, overview of the drug, its proposed indication and dosage. Various divisions within the Agency will be performing the review. These meetings allow you to see how the final step or the review is mapped out before a drug can be released to the market.
There are Clinical Innovation and Science Rounds to advance the special scientific topics such as biomarkers or pharmacogenomics. These groups meet regularly to discuss relevant news related to the specific scientific focus in drug development, and identify impactful journal articles and reviews. As a result, you continuously learn new developments regarding the relevance of your work.
There are also numerous workshops and trainings held for various interests including leadership training, scientific writing refresher, pediatric–dosing considerations, medical counter-measure initiatives, learning to use R, SAS, and even statistical courses. Leading experts in their respective fields, such as external scientists from the industries and special interest groups are all invited to provide their views and suggestions on how the Agency can improve its service to the American public.
Okay, you might be thinking that sounds great on the professional front, but what about work-life balance? The FDA is actually one of the best places to work for if you have a young family. First of all, once you have worked for 6-12 months on a full time basis, you can apply for “Flexiwork,” with the approval of your supervisor. Flexiwork means that you are allowed to work remotely up to 2 days of the week and, considering that there’s rush hour everyday, you would really appreciate the significance of this perk.
There is also an excellent daycare center right on the campus, which the FDA actively works with, monitors and participates in the selection of the childcare provider. There is also a strong support for breastfeeding mothers and dedicated rooms for this purpose.
Finally, to correct some misconceptions about the FDA, I know some people who have not understood well the meaning of the saying “every drug recalled has to be first approved by the FDA.”
FDA conducts rigorous analyses on data provided by the sponsor, detailed analyses from clinical pharmacologist, statisticians, clinicians etc. They then establish post-marking surveillance requirements to monitor any unexpected adverse events. Certain unexpected events can take time to manifest, and “unexpected, by definition, is what is not anticipated.
The FDA cannot repeat all studies done by the sponsor. It’s too costly, takes far too long, and too many resources would be wasted on repeated studies. If the FDA did repeat every single study, no drugs would reach market, since it can take 10 years for the clinical trials alone and millions of dollars if not over a billion for one drug alone.
Would you prefer it if no drug was ever recalled if adverse events were detected during post-market surveillance? Think of this analogy on baby car seats: certain models of cars have been recalled due to safety concerns, but the manufacturers of these products are applauded for their recalls.
Why not the FDA?
I hope I’ve given some insights into working for a government agency, the FDA in particular. It’s an intellectually stimulating environment, with great people and family-friendly institution. You will understand and gain an appreciation that you are making a difference in protecting the welfare of the American general public.