Disputes involving FDA-regulated products often turn on questions that appear narrow but require a precise understanding of how the Agency operates. A labeling decision, manufacturing record, approval pathway, or inspection finding may become central to a product liability, patent, commercial, securities, or enforcement matter. Selecting the right expert for these disputes requires more than identifying someone familiar with the FDA. According to Jeremy Scholem, a Director at DOAR who manages expert engagements in complex litigation, the expert’s experience should correspond to the relevant Center, product, regulatory pathway, and period at issue. Equally important is the ability to connect that experience to the legal questions in the case.
These distinctions informed the development of DOAR’s Former FDA Expert Team, whose members collectively bring experience across the Agency’s major product centers and the regulatory lifecycle. Across otherwise distinct matters, FDA questions may represent only one part of the dispute while still affecting the broader theory of the case. Yet the label “FDA experience” is often applied too broadly: experience in one Center, product category, or regulatory pathway does not necessarily translate to another. A more deliberate approach identifies former Agency professionals whose backgrounds cover the regulatory functions that repeatedly arise in litigation and assess those capabilities before a case becomes urgent. Developing that breadth proactively makes it possible to align the expert’s experience with the specific issue rather than beginning the search only after a request arises.
Aligning FDA Expertise with the Issues in Dispute
Not all former-FDA backgrounds are interchangeable. Each Center reviews different product types, applies its own regulatory framework, and produces a different record, which directly affects the experience an expert need.
- CDER: Expertise may involve NDA and ANDA submissions, drug labeling, pharmaceutical quality, generic approval pathways, and Hatch-Waxman disputes.
- CBER: Relevant backgrounds often center on biologics, vaccines, and cell and gene therapies, with particular attention to BLAs, manufacturing, potency, comparability, and process controls.
- CDRH: Device matters may require experience with 510(k), De Novo, or premarket approval pathways, as well as design history files, software-driven products, quality systems, and post-market reporting.
- CFSAN and human foods: Experts may address food safety, contaminants, labeling, dietary supplements, consumer communications, and the scientific basis for regulatory decisions.
For Scholem, these distinctions are fundamental to expert selection. A professional who understands drug review may not have the right background for a biologics or medical-device matter. Even the line between drugs and biologics can be complicated because CDER regulates certain therapeutic biologics. Combination products may bring two Centers and multiple regulatory standards into the same dispute.
Building a Former FDA Expert Team for Complex Litigation
Complex FDA litigation often requires expertise that spans multiple regulatory functions, including product review, compliance, enforcement, inspections, manufacturing quality, policy, and public health communications. Regulatory questions may involve approval pathways, clinical evidence, Chemistry, Manufacturing, and Controls (CMC), current Good Manufacturing Practices, labeling, risk management, safety reporting, recalls, or other aspects of the FDA framework, depending on the dispute.
For Scholem, however, identifying the need for an FDA expert is only the starting point. The more important question is whether a particular professional’s experience actually aligns with the regulatory issues at the center of the case. Building an effective expert team involves more than assembling recognizable credentials. It requires understanding where an expert worked within the Agency, the decisions that person handled, the product categories and regulatory pathways involved, and whether that experience relates directly to the disputed conduct.
Effective FDA expert selection requires more than identifying someone who held a senior role within the Agency. The most relevant experience often depends on the products and submissions the individual handled, the responsibilities they exercised, and how closely that background matches the questions at issue in the litigation. Litigation also demands capabilities that differ from regulatory service alone. Experts must be able to analyze a developed factual record, distinguish between regulatory requirements and industry practice, communicate complex concepts clearly, withstand scrutiny, and remain disciplined about the limits of their expertise.
Communication ability is equally important. Former regulators are often asked to explain highly technical regulatory histories to attorneys, judges, and jurors who do not work within the FDA system. An effective expert must be able to explain what a document means, how the Agency would have evaluated it, and where its significance may be overstated or misunderstood.
Former FDA Expert Witnesses in Practice
A recent medical-device matter illustrates how specific these engagements can be. The dispute involved alleged failures associated with an implanted device. Counsel needed an expert who could evaluate quality-control practices and explain the regulatory standards governing them. The ideal candidate also needed sufficient statistical experience to assess the supporting data.
DOAR identified a former CDRH compliance professional with more than 30 years of FDA experience whose background includes corrective and preventive action, complaint investigations, Medical Device Reporting, recalls, warning letters, and enforcement actions. His experience allowed the engagement to address the manufacturer’s quality-control practices and the corresponding FDA requirements through one expert because the expert reviewed and approved regulatory and enforcement actions. At the same time, he could provide firsthand context on what the Agency expected from manufacturers.
His work has focused on reviewing the manufacturer’s quality systems, complaint handling, reporting practices, and the regulatory record surrounding the device, then placing those materials in the context of the FDA requirements in effect at the time. That helped the legal team separate regulatory compliance issues from broader questions about product performance and identify which facts matter from an FDA perspective. In another matter involving food advertised as “healthy”, the dispute centered on naturally occurring traces of heavy metals in plants. Scholem and the DOAR team determined that the matter required someone with experience in trace element testing for food products, rather than general regulatory knowledge.
DOAR retained a former nutritionist and research chemist with a background in food testing and recall determination. The expert has since reviewed the manufacturer’s underlying safety data and prepared a report explaining why the FDA permits certain low levels of heavy metals as inherent in natural products.
Selecting and Vetting Former FDA Expert Witnesses
The description “former FDA official” does not automatically make someone the right expert. The Agency is too large, and its work is too specialized, for that credential alone to establish fit.
Conflicts can narrow the pool substantially. Many former FDA professionals maintain consulting practices or have worked with manufacturers and industry associations. Prior affiliations may create formal conflicts or affect how opposing counsel and factfinders perceive the expert.
Publication histories also require close review. An expert may have written extensively about the subject in dispute, but prior positions can affect the current opinion or create vulnerabilities during cross-examination.
In other matters, the requested expertise can become exceptionally narrow. A food-related case may require experience with a particular contaminant in a specific product category. A medical-device matter may call for someone who understands both the applicable clearance pathway and the software, robotics, or engineering behind the product.
This combination of frequent conflicts and a shallow pool most often makes it difficult to find the right FDA expert. It may seem that a large cohort should be available with experience in a field, given how many products the Agency would have reviewed, but further discussion reveals that the FDA’s culture of collaboration meant most of the group worked on a particular regulatory action.
These considerations make early expert planning particularly valuable. Defining the regulatory question at the outset lets the search focus on the experience that matters most while leaving time to evaluate conflicts, prior statements, communication skills, and fit with the broader case strategy.
The Role of Former FDA Experts in Emerging Litigation
FDA-related litigation will continue to evolve alongside the products the Agency regulates. Cell and gene therapies, software-driven medical devices, combination products, advanced manufacturing, and new uses of health data are creating questions that cross traditional scientific and regulatory boundaries.
Scholem views the development of DOAR’s Former FDA Expert Team as an ongoing process. It requires anticipating where disputes may emerge, recognizing gaps in available expertise, and identifying professionals with the right Agency experience before a particular need becomes urgent.
The recent major changes in staffing, policy, and enforcement priorities from the FDA have the potential to cause at least two major issues that will lead to litigation. A shortage of relevant regulators is likely to create either rushed approvals or bottlenecks in the approval process; rushed approvals lead to greater chances of product liability actions down the line, and delayed approval processes are likely to drive litigation about whether commercially reasonable steps are being used to bring drugs to market in the new environment. Meanwhile, foregone inspections are likely to lead to different types of product liability actions.
Across these engagements, the central lesson is that effective FDA expert selection depends on alignment. Once the regulatory question, relevant Center, product, pathway, and audience are clearly defined, counsel can identify an expert whose experience fits the case rather than relying on credentials alone. That precision lets former FDA professionals provide the context complex regulatory records often require.
