Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to dispel incorrect preconceptions about this interactive process for board members or investors. Premier Consulting has represented clients in over 1,000 meetings across all FDA divisions, and we have compiled a list of common misconceptions stakeholders have about Agency interactions.
Misconception 1: Meetings with the FDA are not time- or cost-effective.
It is true that setting up a successful meeting with the FDA can be a time-consuming and intellectually demanding task. But consider the time and resources that sponsors often exhaust pursuing dead ends, conducting unnecessary studies, or, worse, augmenting and re-submitting a deficient IND after receiving a clinical hold or an incomplete NDA after receiving a Complete Response Letter. The FDA can provide spot-on commentary about a program, help to address deficiencies, and thus shorten time-to-market.
This case study offers a real-world example of how holding a successful FDA meeting significantly reduced one Premier Consulting client’s development costs and sped up market approval for its product.
Misconception 2: Interactions should focus only on the immediate next steps.
When meeting with the FDA, sponsors often tend to focus narrowly on what is immediately ahead. For example, a sponsor preparing to submit an IND may be concerned about specific IND-enabling nonclinical studies or the adequacy of its chemistry, manufacturing, and controls (CMC) information to open the IND.
Although it is important to clear the obstacles immediately ahead, it is equally imperative to have the end goal in mind. While determining whether results from a particular rat study are sufficient to open an IND, a sponsor should not forget to ask whether its proposed Phase 3 clinical study—which may take place months or years down the road—will support the product’s indication. Engaging early on with questions about the adequacy of the entire program will help sponsors anticipate and avoid pitfalls, articulate risks and opportunities to investors, and achieve approval in the shortest and least painful way possible.
Misconception 3: Hearing “no” equals failure.
We all love to hear a resounding “yes” when seeking something we desire, and, as humans, we are primed to react negatively when we get “no” as an answer. When it comes to FDA meetings, not unexpectedly, a refused proposal or strategy can send the sponsors back to the drawing board and significantly impact development timelines. This may steer sponsors to avoid questions to which they expect a negative answer.
Nonetheless, when walking into a meeting with the FDA, it is important to set expectations and to understand the true value in walking out with a clear roadmap. Thoughtful questions can be critical to harnessing information that will strengthen a development program and avoid unpleasant surprises later, even if the answers are negative. In a nutshell, knowing that something cannot be done is better than moving forward with ambiguity and doubt.
Misconception 4: It is best to downplay program weaknesses.
Sponsors are in the best position to identify the strengths and weaknesses in their development programs. Understandably, they sometimes hesitate to bring a magnifying glass to potential weaknesses for fear that doing so will cause the whole program to unravel. However, this “out of sight out of mind” approach is not advisable.
FDA staff members are trained to spot potential risks, and they are likely to identify such weaknesses sooner or later in development. Acknowledging and discussing potential issues as soon as they are identified ensures that there is enough time to address those issues and, from a business perspective, may provide leverage to gain funding for additional studies or development work. And, of course, failure to disclose major issues may lead to legal complications and unacceptable risks to patients and research subjects, tarnishing the scientific endeavor as a whole.
Misconception 5: An adversarial stance can lead to a more favorable outcome.
The FDA’s mission is to protect the public health “by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices”: The FDA does not exist to prevent progress or add unnecessary regulatory hurdles to a sponsor’s program. FDA staff members share the same passion for science and interest in novel therapeutics that we all do.
That being said, many of the FDA’s numerous regulations and requirements may appear confusing or even unreasonable to the untrained eye. The primary purpose of FDA meetings is to guide sponsors through those regulations, and an adversarial attitude on the part of the sponsor is rarely helpful. At Premier Consulting, we advocate for a credibly aggressive stance, which means we push boundaries while engaging the FDA in scientifically sound, fact-based discussions. This approach has generated a long track record of successful meetings during which we propose innovative development approaches and gain agreement from the FDA on sponsors’ plans.
Premier Consulting has extensive experience representing sponsors at all stages of development in FDA meetings, and our frequent contact enables us to ensure that your development program and Agency interactions align with its current thinking and behaviors. Our team is equipped to guide you through every step of the process—from preparing a request letter to compiling meeting minutes and follow-up questions—so that you can be prepared to succeed in your goals. Contact us to see how we can support your program.