In drug development, information is a strategic advantage. Understanding how the FDA thinks, evaluates data, and reaches decisions is often the difference between a smooth regulatory pathway and an unexpected delay. Yet while companies invest heavily in competitive intelligence and regulatory planning, one powerful source of insight is still underused: the Freedom of Information Act (FOIA).
FOIA allows sponsors to access valuable FDA documents, everything from review memos to inspection reports, that can illuminate the agency’s expectations and provide real-world examples of how regulatory challenges have been handled in the past. For emerging life science companies, this transparency can level the playing field. For larger organizations, it offers benchmarking opportunities.
This article explores how life science organizations can leverage FOIA as a strategic regulatory tool, transforming historical data into forward-looking guidance.
The Freedom of Information Act, established in 1966 (5 U.S.C.§552), is designed to provide public access to federal agency records. For life sciences organizations, that means the ability to request previously undisclosed FDA documents that shed light on how the agency evaluates drugs and biologics.
Through FOIA, sponsors can gain access to:
While redactions will remove trade secrets or confidential commercial information, the remaining content often reveals patterns, expectations, and actionable lessons. For regulatory teams, this makes FOIA both a transparency mechanism and a competitive intelligence tool—one that benefits organizations of all sizes.
FOIA requests can cover a wide range of document types, many of which can directly support regulatory decision-making.
Commonly Requested FDA Records
Even when redacted, these documents can reveal critical insights, such as the adequacy of endpoint selection, statistical methodology, CMC readiness, or trial design elements that influence FDA decisions. For example, a CRL may redact proprietary assay details but still highlight larger issues, such as data integrity concerns or insufficient validation. These are insights that can guide future submissions.
Every Complete Response Letter tells a story. Across the industry, CRLs reveal consistent themes in what causes delays, and how companies can avoid them.
Studies have shown that approximately 74% of CRL rejections stem from CMC deficiencies, with the remainder driven by clinical, statistical, or sometimes preclinical shortcomings. Reviewing historical CRLs can help regulatory teams identify risk areas long before theFDA does.
A well-known example is Sarepta’s Vyondys 53. The therapy received an initial CRL due to concerns over safety and chemistry/manufacturing controls; however, after addressing these issues and realigning with FDA expectations, the company achieved eventual approval. This type of precedent, available through FOIA, helps other sponsors anticipate what the agency may scrutinize in similar programs.
By analyzing trends across CRLs and other regulatory documents, teams can proactively design stronger studies, prepare more robust CMC packages, and reduce the probability of receiving a CRL themselves.
Filing a FOIA request with the FDA is straightforward, but crafting an effective one requires precision.
How to Submit
All requests must be submitted through the FDA’s online portal.
What to Include
A well-structured FOIA request typically specifies:
Response Timelines
While FOIA legislation requires responses within 20 business days, FDA requests frequently take several months—especially when dealing with older or complex records.
Costs
Fees are typically modest and depend on the scope of the search and the amount of material to review.
Limitations
Key exemptions include:
Even so, the unredacted portions still provide substantial insight into regulatory reasoning and expectations.
FDA Transparency Is Evolving, And FOIA Is More Valuable Than Ever
TheFDA’s 2025 “Radical Transparency” initiative, which will publishapproximately 200 historical CRLs, signals a shift toward openness. In thisinitiative, though, FOIA remains essential:
The combination of newly released CRLs and tailored FOIA requests gives regulatory teams a more complete intelligence picture than ever before.
As the regulatory landscape becomes more transparent, teams must adapt by:
Sponsors who treat FOIA as an ongoing intelligence feed—rather than a one-off request—obtain meaningful foresight into how the FDA operates.
FOIA isn’t a shortcut to approval. But for teams willing to use it strategically, it’s a powerful and competitive advantage. Companies that systematically study FDA decisions gain clarity on expectations, reduce avoidable errors, and ultimately improve the likelihood of regulatory success.
Conclusion
If you’re ready to incorporate FOIA-driven insights into your regulatory strategy, Bracken can help. Our experts analyze CRLs, review files, and inspection records to provide the actionable intelligence you need to strengthen your development program.
Contact us for a meeting with our regulatory affairs team, and learn how FOIA-based intelligence can support your next milestone.