Signs the FDA Dislikes Your Development Plan:  Ignore at Your Risk

November 4, 2015 Joe Lamendola, Ph.D.



In my last blog, I wrote about the four reasons new drug applications usually go off the rails.

During my career, I’ve spent a lot of time helping companies understand the FDA, how it behaves, and how to earn its trust to advance drug development. I’ve found that the FDA has a special language, and the sooner biopharmas learn how to decode this language, the better their chances of establishing a collaboration with FDA and having an agent approved.

Listening and interpreting FDA speak is especially important during an NDA review. The challenge is that not all harsh FDA criticisms appear harsh at all - they can be subtle. I therefore advise people to watch out for these two seemingly harmless cues. Ignore them and they may blindside you and your product later.

  1. Suggestions – The FDA doesn’t always tell a drug development team how to conduct its research and studies. However, they often will make “suggestions.” If the FDA makes a suggestion, listen up: this is code for the FDA pushing your team in a certain direction. If the FDA nudges your team in a direction, it’s important to take this as a definite FDA opinion. If your team disagrees, understand the risk and discuss it with the FDA when meeting with them. It could become a review issue, so you must have a very good rationale for not following their advice.
  2. Silence – While many drug development teams feel relief when an issue or question isn’t raised by FDA during a review meeting, this is a mistake. Sponsors have an obligation to address any issue that might affect a program negatively, and listen carefully to the agency to avoid the issue. Silence does not mean agreement. In fact, silence often means that the issue will come up at the worst time, usually as a complete response letter, which will result in delays.

Because interpreting FDA-speak can be difficult, I always recommend that teams debrief collectively following FDA meetings before transmitting any information back to corporate teams. This allows the team to discuss what each member heard and to reach consensus on the message from the FDA, so the team can present a consistent message based on the experience and insight of the entire team.

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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. 

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