The Commissioner’s Magical Mystery Tour: Many Questions About this Unique Opportunity

FDA recently announced, “CEO Forums: An FDA Listening Tour to Engage Pharma CEOs.” These are scheduled to take place in several cities on both coasts in June and July (here).”

This tour to engage with pharmaceutical and biotech CEOs is unprecedented. According to the announcement, Commissioner Makary will be holding these along with Principal Deputy Commissioner Sara Brenner, M.D., M.P.H and Director of FDA’s Center for Biologics Evaluation and Research, Vinay Prasad, M.D., M.P.H.  The stated purpose of them is to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.

Interested parties must meet specific criteria, including having at least one active IND, NDA or BLA, and must register (registration form). Importantly, final eligibility for attendance will be determined by the FDA. Interestingly, leadership from the Center for Drugs is absent and the tour excludes CEOs in the device space.

Here are some of the unanswered questions:

• Is this a listen-only tour? Should executives expect to hear answers to their questions?
• How will industry participants be chosen? Is there a lottery?
• How many will be present in each meeting?
• Will topics need to be submitted ahead of time?
• Will the meeting discussion be made public?
• What is the output of these meetings?

Like you, we are actively seeking answers to these and other questions.

Listening sessions at FDA are not novel. Speaking from my personal experience, as a former Deputy Division Director in OND, attending listening sessions with patients were not just helpful, but often transformative in better understanding unmet need and helping characterize benefit-risk. We at HPM are optimistic that these listening sessions with CEOs can be equally impactful for product development. Given the recent sudden, frequent and often chaotic changes in the Agency, it is critical that the Commissioner hears directly from Industry about their goals, plans, and concerns. We anticipate the CEOs will have many questions for the Commissioner, including:

• Given that approximately 5% of CDER and CBER staff have left the Agency following significant staff reductions, additional staff continue to exit, and the hiring freeze continues, how can he ensure the safety and efficacy of drugs and biologics? How can the agency avoid the seemingly unavoidable delays to user-fee programs and other critical programs?
• Given the departure of staff with significant institutional and historical knowledge, how does he plan on filling this gap while retaining remaining staff with such knowledge?
• How will he ensure the independent, scientific integrity of the review process?
• How does he plan on implementing the framework for his proposal of a regulatory pathway based on a scientifically plausible mechanism?
• How does he plan on implementing AI in regulatory science and application reviews?
• How does he plan to remedy widely reported low morale among review teams?
• What should industry anticipate with respect to upcoming user fee negotiations?

We will follow this closely and hope that the discussion from these meetings is made public so that all stakeholders can benefit.