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# European Data Privacy Law Affects FDA: Attorney
- URL: https://www.fdaweb.com/european-data-privacy-law-affects-fda-attorney/
- Published: 2022-08-09T12:00:00.000Z
- Updated: 2026-09-14T17:55:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152473

CDER regulatory counsel **Heather Messick**, who was lead on the European Union’s General Data Protection Regulation (GDPR) when she worked in the FDA Europe Office as an international policy analyst, says the GDPR poses several concerns for FDA. Writing in an online *From a Global Perspective* [post](https://www.fda.gov/international-programs/global-perspective/how-european-data-law-impacting-fda?ref=fdaweb.com), she says that so far the agency’s bioresearch monitoring program (BIMO) has been most affected by the law. “There have been instances in which FDA investigators have been unable to complete either in-person BIMO inspections or conduct virtual review of study data due to technology challenges, resource constraints, or data sharing policies, such as GDPR,” Messick writes. “While EU data sharing policies are only one challenge in conducting inspections or remote regulatory assessments, lack of clarity around GDPR has impeded our ability to review data remotely during the pandemic.”

Messick says other GDPR potential concerns for FDA are:

- clinical trial data;
- NDAs/BLAs; and
- adverse event reporting.

She notes that last March the EU and U.S. agreed in principle on a new data agreement for cross-border transfers of personal privacy data for commercial purposes. “The impact of these developments on FDA’s future ability to receive non-public health information from the EU is still unknown,” she concludes.