The U.S. Food and Drug Administration (FDA) is seeking industry and stakeholder input on ways to improve access to patient-level data used in real-world evidence (RWE) submissions for drugs and biological products, according to a November 12 notice in the Federal Register.

The agency wants to identify solutions that would allow it to independently review and verify study results when real-world data (RWD) are used in regulatory applications.

The request for information (RFI) invites comments from pharmaceutical companies, health IT vendors, academic medical centers, electronic data capture providers, patient advocates and other interested parties. Comments are due January 11, 2027.

Third-Party Data Ownership and Access Barriers

According to the notice, sponsors often do not own the RWD used in their studies, and that is a challenge. The data may be held by hospitals, commercial data providers or other third parties, leaving sponsors without authorization to submit patient-level information to the FDA.

The agency says sponsors should establish agreements with data owners that permit the FDA to access relevant patient-level information and inspect source records when necessary. 

However, existing data-use agreements can conflict with the agency’s legal obligations, including federal record-retention requirements, preservation of regulatory records and Freedom of Information Act obligations.

Privacy requirements also complicate access. The FDA points to protections under the Health Insurance Portability and Accountability Act (HIPAA) and the European Union’s General Data Protection Regulation (GDPR), particularly when data move across jurisdictions.

Technical constraints add another layer. Longitudinal records, medical imaging and multi-omics datasets can be substantially larger than conventional clinical trial datasets, creating challenges for transferring, storing and processing information within the agency’s existing infrastructure.

Data Governance and Regulatory Readiness

For chief data officers (CDOs) in pharmaceutical companies, healthcare organizations and data providers, the FDA’s request highlights the importance of clear data ownership, documented permissions and reliable access arrangements. 

Organizations that use third-party health data in regulatory submissions need agreements that account for regulators’ inspection and retention requirements, alongside privacy obligations.

The issue also reinforces the role of data stewardship and governance in making complex datasets usable for regulatory review. CDOs can help establish consistent controls for data access, quality, interoperability and traceability, responsibilities closely connected to the core responsibilities of a CDO.