As any life science veteran will tell you, much of our industry involves working with the FDA. For this reason, no matter your role in the industry, there's an advantage in understanding how and why the FDA works. I'd like to take the chance to recount some of my personal experiences over a number of years working with the Center for Drug Evaluation and Research (CDER). Overall, while many associate government organizations with negative things like drawn out processes, I've found work with the FDA to be more positive than you might think. Here are my seven tips for understanding how to work with the FDA:
1. The FDA Leads with Guidance
My take on the FDA attitude is that they do not obstruct drug research and development but rather provide guidance and recommendations that will assist you in reaching your goal of approval. To that end, when you have a new drug for development in an area different than your personal experience, the first thing to do is look up written FDA Guidance.
2. Guidance Is Reasonably Detailed
FDA guidance is usually quite specific and sound. It gives a step by step the development route that generally must be taken with a drug candidate. If some of the steps seem to be unnecessary or don't quite fit, FDA staff is open to a discussion that can provide excellent direction.
3. The Rules are There for a Purpose
The guidance is expected to be followed. So don't try to skirt ways around some time consuming or expensive step without permission. It just won't work.
4. Understand They Have More Information Than You
From the FDA's point of view, patient safety is always foremost in their mind. So some requirements imposed may seem over much to you, but FDA often has much more information than you have about a new class of drugs. For example, your drug candidate may be innovative and from your information base, no other group has one similar to it. Unknown to you, others may be already on to it but it is kept confidential. FDA can already know much about the drug class and its potential risks so they will insist that you test for a certain laboratory item that doesn't make sense to you. It does to them from other sources that , of course, they cannot reveal to you.
5. Understand They Need More Information When They Can Get It
In virtually every requirement, some past experience has led FDA to impose more and more information from you. It is often frustrating for you but, believe me, almost always there is a good reason for it. I have found, however, that you can always discuss it with them and give your point of view. Works best if you have real data to support your view.
6. Examples of Accelerate Approvals Do Exist
It is quite clear too that FDA is eager to accelerate a promising innovative program for an under treated condition. Numerous examples of this exist including treatment for AIDS and multiple sclerosis. Sometimes approval has been given so quickly that manufacturing cannot release the drug at the time of approval.
7. Leverage Events to Learn More
If you are new to working with the FDA, I recommend attending an upcoming workshop on interacting with the FDA. This FREE workshop in Silver Springs, MD on Friday, May 12th 2017 is given by the FDA Center for Drug Evaluation and Research. For more information please click HERE.