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). Claims libraries rose to the top as an effective approach to mitigate risk and strengthen trust with regulators.
The Value of Documented Processes
According to Dorfman, one of the most powerful tools companies have at their disposal is demonstrating good faith efforts to comply with regulations. Claims libraries serve this purpose exceptionally well because they:
- Create a documented, auditable record of approved claims and their supporting references
- Demonstrate systematic review and approval processes
- Show that the organization takes compliance seriously
- Provide consistency across all promotional materials
Building Trust with Regulators
When the FDA reviews promotional materials and finds issues, the conversation changes significantly if a company can demonstrate they have robust systems in place. A well-maintained claims library shows:
- Proactive compliance efforts
- Investment in regulatory infrastructure
- Commitment to accurate, balanced promotion
This doesn't guarantee immunity from enforcement action, but it does demonstrate good faith—which matters in regulatory relationships.
About SecureCHEK AI
SecureCHEK AI helps companies build and maintain claims libraries while ensuring promotional content aligns with approved claims.