Last week I wrote about the importance of being transparent with the FDA during the clinical research phase of drug development. Biopharmas spend a lot of energy getting an agent through this process. Once that happens, they are faced with the monumental task of getting the drug to the patient.
Over the course of my career I’ve been responsible for 20+ drug approvals. Some went smoothly, and others didn’t. In my experience, when things don’t go well, it’s usually because of four main problems.
- Blinded by our own data. It’s easy to become blinded by your own data, and then try to explain away safety issues. However, the FDA will take an unbiased look at the data and will focus on these safety issues, so it’s better to address adverse events with a plan. The best strategy is to have a clear and honest understanding of the asset under development, including its benefits and risks, and address the risks early with the FDA
- Not knowing the regulatory and competitive landscape well. It’s important for sponsors to understand the regulatory environment in the therapeutic area and drug class, and to know if the FDA has ever addressed this area before. Having an understanding of competitive labels and the safety issues they’ve faced can be very helpful as you prepare the NDA for submission and review.
- Losing credibility with the FDA reviewer. The habit of being transparent with the FDA will pay off during the NDA phase and will build credibility with the FDA. Sponsors should be completely transparent in the NDA—reporting all studies, data and clinical results. This is the best way to ensure the application will get a rapid review, hopefully leading to a rapid approval.
- Not taking advantage of all statutory meetings with the FDA. It’s imperative to take advantage of all statutory meetings with the FDA and to make each meeting as meaningful as possible by addressing issues and asking questions. This is where a partnership with the FDA becomes crucially important. If the FDA doesn’t bring up a potential sticky issue, it’s the sponsor’s obligation to raise it. Ignoring problems or feeling like you “dodged a bullet” won’t make an issue go away.
In addition to preparing carefully for these meetings, listening to what the FDA says in these meetings is an important skill. In next week’s blog, I will discuss the unique language the FDA uses and how to understand these signals.
What FDA application mistakes have you seen? Leave a comment.
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Authored By: Joe Lamendola, Ph.D. is an authority on regulatory affairs and an Executive Partner at YourEncore. He is the former Vice President of U.S. Regulatory Affairs at Bristol-Myers Squibb and responsible for 20+ approvals across 10+ therapeutic areas.