FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries

On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation of Americans’ sensitive genetic data by adversaries, under a “broader national effort to implement Executive Orders 14117 and 14292.” [1]

Executive Order 14117 was issued by the Biden administration in 2024 to establish new export control regulations that prohibit or restrict a U.S. person from engaging in certain data transactions with countries of concern and covered persons. [2] The final rules implementing the executive order specifically prohibits a U.S. person from engaging in “any covered data transaction with a country of concern or covered person that involves access by that count