FDA's Future: Insights from Former Commissioner David Kessler

FDA's Future: Insights from Former Commissioner David Kessler

Speaking at the STAT Breakthrough Summit West on May 19, 2026, former FDA Commissioner David Kessler expressed cautious optimism about the agency's ability to thrive despite recent high-profile departures and internal turmoil. This analysis distills his insights and outlines implications for pharmaceutical business development and regulatory strategy teams.

Key Takeaways

• Former FDA Commissioner David Kessler acknowledged the agency is currently “fragile” but remains “the center of American medicine” and can still thrive with the right leadership and retention of institutional expertise.
• Seven former FDA commissioners have publicly warned that the current administration is undermining the agency’s credibility, adding political pressure on top of operational strain from high-level staff exits.
• For pharma BD and regulatory teams, the near-term risk includes extended drug review cycles and shifting enforcement priorities; proactive engagement with FDA review divisions and scenario-planning for M&A deal models are critical adaptive steps.

The development

On May 19, 2026, David Kessler — who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton — took the stage at the STAT Breakthrough Summit West in San Francisco. In a wide-ranging interview with STAT’s Matthew Herper, Kessler addressed the agency’s recent turmoil: a cascade of senior staff departures — including the director of the Center for Drug Evaluation and Research and several division chiefs — that has rattled industry confidence. Kessler described the FDA as “fragile,” yet he argued that its deep bench of scientific talent and unwavering public health mission make it uniquely resilient. “It is still the center of American medicine,” he said, expressing faith that acting FDA Commissioner Kyle Diamantas has what it takes to bring stability.

Kessler’s remarks come amid a broader political storm. In a letter released earlier this month, seven former FDA commissioners — including Robert Califf, Mark McClellan, and Margaret Hamburg — warned that the Trump administration’s policies are systematically undermining the credibility of the FDA. The letter, published by Duke University’s Margolis Center for Health Policy, cited budget cuts, politicization of drug approvals, and erosion of scientific independence as core concerns. The FDA itself has not issued a formal response to either Kessler’s comments or the former commissioners’ letter.

The cumulative effect of these pressures has been a growing sense of unease in the pharmaceutical industry. Drug developers are already reporting longer wait times for pre-submission meetings and inconsistent feedback from review divisions, according to industry sources. Kessler acknowledged these frictions but urged the audience not to write off the agency. “We have seen tough times before,” he said, pointing to the FDA’s recovery from the generic drug scandal of the late 1980s and its rapid pivot during the COVID-19 pandemic.

Implications for pharma BD and regulatory teams

For business development and regulatory teams, Kessler’s assessment signals both short-term uncertainty and long-term opportunity. The most immediate risk involves drug approval timelines. Key staff departures and strained morale may slow the FDA’s review clock, particularly for complex submissions like cell and gene therapies or novel combination products. Companies with late-stage assets targeting PDUFA dates in the next 12–24 months should build buffer timelines and maintain early, frequent communication with their assigned review divisions. The FDA’s Center for Drug Evaluation and Research (CDER) has historically maintained rigorous review standards; any erosion in staffing could disrupt the delicate machinery of advisory committee meetings and label negotiations.

Regulatory strategy leaders should also monitor hiring trends and any shifts in enforcement priorities. The FDA’s ability to issue warning letters, enforce post-marketing requirements, and update guidance documents may slow, creating both regulatory risk and competitive openings. Companies that invest in proactive regulatory intelligence — tracking which divisions are best staffed and which are strained — can prioritize submissions accordingly. For BD teams evaluating M&A or licensing targets, regulatory timeline risk must be baked into deal models. A six-month delay to approval can shift NPV calculations by tens of millions of dollars, particularly for assets with limited patent life remaining.

On the positive side, Kessler’s confidence that the FDA’s core scientific capacity remains intact suggests that well-prepared, thoroughly documented submissions will likely still receive timely reviews. The agency’s institutional memory — retained in mid-level reviewers and long-serving staff — provides a buffer against leadership churn. Teams that maintain strong regulatory engagement strategies — such as regular Type C meetings, clear data packages, and proactive responses to information requests — can differentiate themselves in a resource-constrained environment. The European Medicines Agency (EMA), facing its own post-Brexit staffing challenges, offers a cautionary parallel: those who anticipated delays by filing earlier and engaging more frequently with regulators have seen better outcomes.

For BD managers, the current environment may also create acquisition opportunities. Smaller biotechs with promising assets but limited regulatory experience may see their stock prices depressed by uncertainty, making them attractive targets for larger companies with seasoned regulatory affairs teams. However, buyers must conduct thorough due diligence on the FDA review history of any target’s lead programs, especially if recent interactions have been inconsistent. The key is to treat regulatory risk not as a binary obstacle but as a measurable dimension that can be managed through preparation and contingency planning.

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