Regulation / Privacy / Strategy
FDA asks for input on getting patient-level real-world data behind drug and biologic submissions
A request for information looks at how sponsors that do not own real-world data can give the agency access to verify results, amid data-use agreement, privacy and technical hurdles.
The US Food and Drug Administration has opened a request for information on improving its access to patient-level data used in real-world evidence (RWE) submissions for drugs and biological products, according to a 12 November Federal Register notice reported by CDO Magazine. The agency wants ways to independently review and verify results when real-world data (RWD) underpin applications. Comments are due 11 January 2027.
According to the notice, sponsors often do not own the RWD they use; hospitals, commercial data providers or other third parties may hold it, leaving sponsors without authorisation to submit patient-level records. The FDA says sponsors should agree terms with data owners that allow it to access data and inspect source records.
The agency also cites conflicts between data-use agreements and federal record-retention and Freedom of Information Act duties, privacy constraints under HIPAA and the GDPR, and the size of imaging, longitudinal and multi-omics datasets.
Editor’s note: The date, deadline and docket are checked against the Federal Register notice; the details of the challenges follow CDO Magazine’s report of it.
Why it matters
Life sciences sponsors relying on licensed third-party health data should review whether their data-use agreements permit FDA access to patient-level data and inspection of source records, as the agency says sponsors should arrange, and whether existing terms conflict with the FDA's record-retention and FOIA obligations. Where data move across jurisdictions, privacy and data protection teams should assess how HIPAA and GDPR protections affect FDA access. Data stewards should be able to document provenance and lineage from submitted datasets back to source records held by external data owners.
Status: Consultation. Request for information; comments due 11 January 2027
Key dates
- Comment deadline for FDA request for information on patient-level RWD access in RWE submissions
Sources
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Governance areas
Who should care
- CDO
- DPO
- Legal & compliance
- Data stewards