The FDA has split the market into 7 key programs or areas of operations. These areas break down into 28 subgroups that can be used to organize and categorize the market for staff management. But before I get into all that and why it’s important, let me give you a little history behind the change.
A Little History
In 2013, the FDA faced growing challenges due to developments in technology and globalization that made it difficult to keep up with advancements in the food and drug industries. So on September 6th Commissioner Margaret A. Hamburg, M.D., created the Program Alignment Group (PAG) to address them. By 2014 the group had developed a 5-year plan on what to do about these issues, with yearly action plans to help implement them.
One of the things that came out of this program alignment was a fundamental shift in how the FDA manages the breakdown of its staff. On May 15th, 2017 the FDA transitioned from operating on a geographic regional basis for management to a program-based management structure.
This allows for staff to be specialized in their focus, making it possible to keep up with the ever-changing demand of innovation and advancement. Instead of covering a geographical area, they can cover topics and become experts in those fields.
Because of the new structure, the market was divided up into 7 major categories.
1. Biological Products
2. Bioresearch Monitoring
3. Human and Animal Food
4. MedicalDevices and Radiological Health
5. Pharmaceutical Quality
Each of these categories are responsible for over seeing different aspects of the Food and Drug markets. Understanding what each category covers can help you to identify which one your project or operation falls under.
Why That’s Important
You now have a dedicated inspector that is very well versed in the subject of your project. They are no longer assigned to your region, but to your category of pharmaceuticals. That allows them to stay up to date on any emerging technology in their field. This also means that you won't be getting inspectors that know your region but don't have much experience or knowledge on the issues they are inspecting. I leave it to you to interpret the cost/benefit status on that information.
Once you know what category your companies project falls under, you can begin to familiarize yourself with that office and get to know the staff that work there. Developing a relationship with the people in that office can make it easier to reach out to them when you have questions or concerns during a project. Getting preventative assistance from the FDA can potentially save you lots of time and money. You will also know what to expect during inspections and can more easily prepare for it.
This new system that the FDA is using to structure their staff and focus their efforts hasn’t been around very long so it will be interesting to see how well it works and what kinds of impacts it will have on the market long term.