Proactive planning and communication with FDA is critical to regulatory success

“Of a good beginning cometh a good end.”

Chinese Proverb

By Laurie Smaldone Alsup, MD

It’s common knowledge that communicating early and regularly with the FDA is critical to regulatory success. Getting the review division’s opinions on study design and plans, collaborating and addressing their concerns early are imperative to a healthy relationship as well as creating a sound development program grounded in the latest science. This should be easy, right?

Time after time, we see Sponsors fail to ask or heed the advice of the agency, instead moving forward with their original plan, only to find themselves struggling to argue for approval. Development teams miss the fissures in their evidence, obscured by rose-colored glasses and siloed echo chambers. Even with solid data, teams that lack an integrated and aligned strategy may falter in regulatory, clinical and payer interactions to the detriment of subsequent steps such as advocacy, acceptance, and uptake in the market.

No amount of transparency and good intentions can prevent the domino effect of lack of proactive planning and communication with Regulators, which is why it’s imperative to start early to identify weaknesses, agree on messaging and strategy, and develop a communications plan for regulatory approval and commercial success. With a firm foundation and internal alignment, even the most complex data and uncertainties can be communicated clearly and defended.

This foundation is built on the cornerstones of external eyes, gap analysis/critique, and strategic messaging layered into the submission and all of the other deliverables and opportunities that follow — from a pre submission to FDA Applicant Orientation to an Advisory Committee meeting (all critical steps along the path to approval). It should begin well before submission, with the support of independent experts to help critique and develop appropriate strategies and messaging to support approval. In this way, the sponsor can align the narrative across key submission documents and carry it forward to the critical milestone events ahead.

Ex-regulators, drug developer clinicians, and communication experts are important external eyes who aren’t suffering from application fatigue and aren’t afraid to raise issues and solutions. They can look from a fresh perspective and facilitate agreement and next steps… to bake it into the submission, for the US, Europe and globally. This early preparation and collaboration can prevent the dreaded, “I wish we had included that analysis in our submission” thought later in the approval process.

With the benefit-risk argument laid out clearly in the submission, half the battle is won. Nonetheless programs may have limitations such as missed endpoints, single pivotal trials or other data challenges that require more discussion. An AOM may be all the team needs to further make the benefit/risk case.

Teams that rigorously prepare for that interaction with their review team may find that they can address the reviewers’ concerns sufficiently. But if the agency should decide it wants the input of an Advisory Committee, the groundwork has already been laid for that critical, public interaction. With a strategic messaging map and argument for approval in hand, the Sponsor has a thoughtful head-start to preparing to present and defend their case before an Advisory Committee.

Engaging outside expertise early, testing the messaging and strategy and aligning the team internally are all keys to bringing treatment to patients in a timely manner. Of a successful beginning comes a successful end.


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