Why Claims Libraries Demonstrate Good Faith Efforts Amidst FDA Crackdowns
I had the pleasure of interviewing regulatory, compliance and legal expert, Howard Dorfman, JD, about the recent crackdowns on promotion by the FDA’s Office of Prescription Drug Promotion (OPDP). Rising regulatory pressure has renewed scrutiny of pharmaceutical promotional materials, with numerous untitled and warning letters issued for misleading claims, overstated efficacy, and unsupported data.
Howard shared several best practices for mitigating risk and strengthening trust with regulators, agencies, and internal review teams. Claims libraries rose to the top as an effective approach to accomplish both objectives. According to Howard, a robust claims library functions as the backbone for enhancing promotional review efficiency and strengthening a company’s compliance ecosystem by housing substantiated claims derived from approved labeling, regulatory guidance, and validated evidence.
Below is a summary of Howard’s remarks.
It’s important to have an auditable, evidence-based framework to validate that all promotional claims are substantiated and compliant. Centralized, authoritative claims libraries are increasingly viewed as both operational enablers and regulatory safeguards, ensuring promotional content is accurate, traceable, and defensible.
1. Defensible Compliance Framework: Claims libraries demonstrate a company’s commitment to compliance by:
Enforcing the use of only approved claims in promotional content
Anchoring every claim to its authoritative source for instant verification
Documenting due diligence through a formal, auditable review process
2. Protection Against Regulatory Risk: Libraries reinforce a company’s ability to defend its materials against allegations of misleading “net impression.” They address key OPDP enforcement concerns, including:
Overstated efficacy, rapid therapeutic onset, and Quality-of-Life claims
Use of inadequate or outdated data to support promotional messages
Formatting and presentation issues such as font size, pace, or scene transitions
3. Continuous Monitoring and Rapid Label Updates: A centralized library provides a systematic, traceable process to:
Update claims following label revisions
Document timely field material replacements
Demonstrate compliance to auditors and regulators
4. Audit Efficiency and Risk Reduction: Automated claims verification accelerates field audits, replacing manual testing with traceable, systemized confirmation that materials align with approved sources. This demonstrable diligence can:
Shorten audit timelines
Reduce exposure to penalties
Help avoid consent decrees and other enforcement actions by evidencing proactive compliance management
Beyond efficiency gains, the adoption of structured claims libraries signals a company’s proactive commitment to due diligence, transparency, and good faith in regulatory compliance. In an era of heightened FDA scrutiny, claims libraries represent more than an operational convenience—they are an important component of a regulatory defense mechanism and a core governance asset by institutionalizing verification, traceability, and accountability.
In addition to the support provided to a company’s internal Medical, Legal and Regulatory review function, a claims library provides a company’s external promotion developers with the approved messaging. In turn, this resource minimizes errors in the development of promotional materials and expedites completion of a company’s promotional and educational campaigns.
Mr. Dorfman can be reached by email at hldorfman@gmail.com or phone (203) 464-0634.
About SecureCHEK AI
SecureCHEK AI is purpose-built for pharmaceutical, medical device and biotech companies to expedite essential review of regulated materials, so they impact sales sooner. The cloud-based software seamlessly integrates with enterprise CMS/DAM platforms to accelerate MLR efficiency.
SecureCHEK AI deploys the gold standard in AI technology, a full hybrid model that combines Analytical/rules-based AI, GenAI, RAG and humans in the loop for superior accuracy, verifiability and auditability. This contrasts to GenAI-only software solutions that risk hallucinations and inaccuracy., reducing trust and confidence in findings. Rapid deployment and the user-friendly interface minimize the learning curve, making it easy to get started.
Contact us for a demo to learn how SecureCHEK AI builds libraries and executes prechecking.