FDA, up close and personal: A banker’s recalibration

A former agency advisor’s view from inside FDA: What industry often misreads as dysfunction is rooted in caution, independence and process discipline

FDA has long been criticized as slow, opaque and largely dysfunctional. A year marked by leadership turnover, political pressure and high-profile regulatory controversies has amplified that narrative. After four years inside government — three at FDA, followed by one at ARPA-H — I’ve come to a different conclusion: The agency is largely working as designed.

While the agency is under strain, my experience there, which involved helping to formulate and implement high-priority enterprise-level strategic initiatives, convinced me of the strength of its underlying fundamentals.

The agency’s core logic — its independence, caution and process discipline — won’t be easily changed, even amid political pressure and leadership disruption at the top. The problem is that the very industry that depends on FDA often misunderstands how the agency is designed to work.

The recalibration required of me upon entering government was profound. FDA does not operate with the same objectives, incentives or time horizons as the private sector. Much of the friction between the agency and industry stems not from disagreement over outcomes, but from a fundamental misalignment in how each side perceives the other’s role.

The people: better than the caricature

Start with what is often missed. FDA is staffed by an extraordinary group of professionals — highly trained, deeply experienced and genuinely committed to public health. These are not the bureaucratic caricatures of political rhetoric. Many would command significantly higher compensation in the private sector, yet choose public service for exactly the reasons one would hope. They’re not there for their health; they’re there for ours.

That commitment is not abstract. I recall Monday morning briefings with senior agency leadership where forthcoming product approvals — often addressing a serious unmet need — were previewed. The reaction was not procedural; it was personal. There was a palpable sense of ownership and pride in advancing therapies that would meaningfully affect patients’ lives.

No organization of 19,000 people is uniformly excellent, and FDA is no exception. But at the leadership and career-staff levels that drive decision-making, the depth of expertise and seriousness of purpose are striking.

Independence above all

If there is a single defining feature of FDA’s staff culture, it is its fierce commitment to independence — particularly from perceived external influence, whether commercial or political.

This is not posturing; it is foundational. Scientific and clinical staff are trained, and culturally conditioned, to guard against even the appearance of external pressure. Established regulatory pathways and center-based decision authority are treated not as bureaucratic artifacts, but as protective mechanisms designed to preserve the integrity of the process.

That sensitivity extends beyond industry influence. In today’s highly visible and contested policy environment, FDA staff are acutely aware of potential political pressure — direct or indirect — and maintain distance from external agendas accordingly. Public statements that appear to pre-judge regulatory outcomes can heighten that sensitivity.

That culture shapes behavior in ways that can surprise those coming from industry. Shortly after I joined the agency, then-Acting Commissioner Janet Woodcock told me that it would take nine to 12 months to “launder” me — her shorthand for the time required for career staff to become comfortable with the idea that a longtime Wall Street banker could operate within FDA’s norms. The comment was half in jest, but only half.

The same dynamic operates externally. Relationships that had been routine in my prior career became more constrained, and appropriately so. Companies are understandably cautious about any interaction that could be construed as influence, and FDA staff are equally disciplined in how they engage. The intense scrutiny surrounding Biogen Inc.’s interactions with the agency during the review of its Alzheimer’s disease drug Aduhelm is a reminder of how quickly perceived proximity can become a liability — for both sides. 

Why everything feels so slow

The most visible manifestation of this culture is speed — or, more precisely, the lack of it.

Nothing at FDA happens quickly, but that is not primarily the result of inefficiency, and certainly not indifference. It reflects decades of purposeful policy layered in response to past failures or crises — each adding process, guidance and constraint. Over time, these layers accumulate into something akin to geological sediment: dense, complex and difficult to move.

The agency is not only deliberate, but also culturally cautious about change itself. During my time at FDA, I was involved in the largest reorganization in the agency’s history, affecting nearly 40% of the workforce. What stood out was not resistance in the traditional sense, but the extraordinary care required to implement even well-justified change. The effort to socialize the reorganization internally — ensuring alignment, minimizing disruption and maintaining trust — far exceeded anything I had experienced in the private sector. Change, in this environment, is not something to be imposed quickly.

This is the central tension that FDA manages every day: enabling innovation while minimizing the risk of getting it wrong. The balance is imperfect, and reasonable people can disagree about where it should be struck. But it is not accidental.

The internal reality: stability beneath the surface

The past year has brought an unprecedented level of leadership turnover and turmoil across FDA’s core drug and biologics centers. These changes have cut deeply into institutional expertise and memory, leaving gaps in regulatory process and culture that are not easily repaired.

And yet, beneath that senior layer, the agency retains a deep bench of career professionals who understand the science, the process and the culture. These individuals provide a critical source of continuity. They are the connective tissue of the organization, quietly maintaining standards and carrying out the real work irrespective of distracting changes at the top.

That does not eliminate the impact of leadership disruption, but it does temper the more dire narratives about institutional collapse.

Implications for industry

For industry, that continuity matters because it shapes the logic underlying the agency’s decision-making. Understanding that logic is not academic — it has practical implications for how companies should approach the agency.

First, early engagement matters, but expectations must be calibrated. The agency encourages dialogue and has established formal access structures within defined boundaries. The goal is not to negotiate outcomes, but to clarify pathways and surface issues early.

Second, adherence to established processes is not optional. FDA reviewers are understandably reluctant to deviate from prescribed protocol or precedent without compelling justification. To be sure, the agency can — and does — exercise flexibility when circumstances warrant. But that flexibility is driven by science and clinical need, not by attempts to engineer bespoke regulatory pathways, which more often create friction than advantage.

Third, companies should be mindful of internal dynamics within the agency. While interactions are outwardly collegial and consensus-driven, decision-making authority is distributed across centers and offices with distinct mandates and perspectives. Efforts to play one part of the agency against another are unlikely to succeed and could provoke resentment.

Fourth, global strategy has never been more important. Parallel engagement across major regulatory jurisdictions is no longer just a market access consideration; it is a strategic imperative. Divergence in policy frameworks — combined with increasing uncertainty in the U.S. regulatory environment, including IRA and MFN dynamics — makes reliance on any single pathway risky. Maintaining multiple regulatory options can provide not just flexibility, but leverage.

The verdict

None of this is to minimize the gravity of recent policy and leadership decisions, which have had real consequences for innovation and patient welfare.

That said, I do not share the more pessimistic view — held by some current and former senior FDA officials — that the recent period of disruption will take decades to unwind. Having spent nearly 40 years in the private sector before entering government, I tend to view large, complex organizations as more adaptive over time than they are often given credit for.

Disruption can also force a clearer articulation of priorities — what is essential, what is negotiable, and what is durable. In that sense, it can act as a forcing mechanism for clarity and progress. I believe this is one of those moments, and that the most consequential adverse outcomes will ultimately be avoided.

FDA has a long and well-earned history of scientific rigor and meaningful contributions to public health, even through recurrent periods of disruption or controversy. This present period is best understood as part of that continuum rather than an aberration from it. The system is under strain, but it is also adaptive — and it has repeatedly proven more durable than its critics or its internal pessimists will admit.

That durability, however, does not absolve industry of responsibility. If anything, it heightens it.

What often appears as procedural friction is, in fact, a reflection of fundamentally different assumptions about risk, evidence and responsibility. Understanding those assumptions — and engaging FDA on its own terms — is essential to making progress within the system.  

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Peter N. Reikes recently concluded four years in government, serving as senior advisor at FDA and senior strategy advisor at the Advanced Research Projects Agency for Health (ARPA-H), after nearly four decades as a healthcare investment banker.

Signed commentaries do not necessarily reflect the views of BioCentury.