FDA Abandoning Expert Reviews: Implications for Drug Developers and Quality Professionals

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The pharmaceutical industry stands at a critical juncture, as a recent report suggests FDA is considering a significant departure from its long-standing practice of utilizing external expert advisory committees for new drug applications (1). This potential shift, initially signaled by George Tidmarsh, head of FDA’s Center for Drug Evaluation and Research, has profound implications for regulatory strategy, transparency, and internal quality systems, directly impacting the core concerns industry professionals.

What is Tidmarsh’s rationale?

Historically, FDA advisory committees, established in their current form in 1972, have served a crucial role by convening external experts to review evidence and vote on the approval of drugs, vaccines, and medical devices, particularly when the agency faces complex or difficult decisions (2). Tidmarsh, however, argues that these panels are redundant and time-consuming, involving "a tremendous amount of work for the company and for the FDA." He suggests that the agency should instead focus its efforts on "big questions," such as evaluating appropriate endpoints for different drug classes.

A key part of the FDA's rationale for this potential change is the recent initiative to publish Complete Response Letters (CRLs) in real time (3). These letters, which previously required Freedom of Information Act requests, provide developers with "early insight into regulatory deficiencies to improve development planning." Tidmarsh posits that releasing CRLs promotes a level of transparency "akin to the advisory meetings’," suggesting the letters make expert committee meetings on individual drugs redundant (1).

However, this perspective is met with considerable pushback from former FDA officials, academics, and industry experts. Critics argue that abandoning expert reviews would "shield the agency’s decisions from public scrutiny” (1). Robert Califf, former FDA Commissioner, finds Tidmarsh’s reasoning "hard to follow," emphasizing that it is "extremely useful for people inside FDA to find out what other experts think before they make their final decisions" and essential for public understanding (1).

How do CRLs and expert review committees differ?

Experts highlight several critical differences between CRLs and advisory committee meetings:

• Public Input and Dialogue: Advisory committees allow experts to ask questions of the company or FDA that might not have been considered, and provide a vital public forum for comment on FDA decisions (1). A disclosed CRL informs the public why an application was rejected, while an advisory meeting seeks input before a decision is made, a crucial distinction.

• Internal Consensus and Scrutiny: Committees often help settle disagreements within the FDA itself, providing an external, unbiased perspective that can strengthen decisions (1).

• Rigorous Evaluation: While the FDA is not obliged to follow committee votes, their input is particularly valued for "important new types of medications or when a decision is especially tricky because of high demand for a product that may have limited value," as exemplified by the controversial approval of Biogen's Aduhelm despite a "no" vote from its advisory committee (4).

For industry professionals, this potential shift carries significant implications across various domains:

Regulatory strategy and drug development

Companies will need to closely monitor how drug approval pathways might evolve. If external expert validation becomes less common, drug developers may need to anticipate heightened internal FDA scrutiny or adjust their data submission strategies to preemptively address potential concerns that would typically be vetted in a public forum.

Quality systems and compliance excellence

A less transparent or externally validated regulatory environment could place even greater emphasis on robust, holistic internal quality systems to ensure compliance excellence and mitigate risks without the benefit of public expert debate (5,6). Ensuring data integrity and quality of data will become even more paramount for regulatory compliance and patient safety (7).

Transparency and public trust

The pharmaceutical industry operates under intense public scrutiny. A move away from public advisory committees could, as critics suggest, reduce transparency and potentially erode public trust in drug approvals (1). This would necessitate companies to be even more proactive in communicating their commitment to quality and patient safety.

Strategic focus on "big questions"

While Tidmarsh indicates committees would still be consulted on general regulatory issues, the absence of detailed, specific drug reviews could alter how industry and the FDA collaboratively address emerging scientific and manufacturing challenges (1).

Evidence of this shift is already emerging, with the FDA holding only seven advisory committee meetings since the current administration entered the White House, compared with 22 in the same period last year (1). While some initially viewed this reduction as temporary, others perceive it as a "strategic" move to "consolidate power in the agencies" and reduce accountability to outside experts or the public. Concerns have also been raised about the potential for replacing public, vetted committees with "handpicked scientists" who may align with specific views.

As the FDA navigates these changes, industry professionals, from drug development and manufacturing professionals to those in quality systems and regulatory affairs, must remain vigilant. Understanding the evolving regulatory landscape, proactively strengthening internal quality and compliance frameworks, and upholding the highest standards of transparency will be crucial for success in this new era of drug approval.

References

1. Allen, A. Under Trump, FDA Seeks To Abandon Expert Reviews of New Drugs. KFFHealthNews.org. September 12, 2025.
2. NIH. Historical Evolution of FDA Advisory Committees. Accessed September 12, 2025.
3. Lavery, P. FDA Initiates Real-Time CRL Publication: What It Means for Drug Developers. PharmTech.com. September 5, 2025.
4. Allen, A. Inside the Tactical Tug of War Over the Controversial Alzheimer’s Drug. KFFHealthNews.org. February 16, 2022.
5. Cole, C. PDA 2025: FDA Experts’ Proactive Strategies for Mastering 483 Responses. PharmTech.com. September 10, 2025.
6. Lavery, P. AI and Digital Oversight in Pharma Supply Chains: PDA Regulatory Conference Insights. PharmTech.com. September 9, 2025.
7. Cole, C. Navigating Regulatory Training: Digital Transformation Strategies for a Smarter Pharma Workforce. PharmTech.com. September 9, 2025.