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 country of concern or covered person to bulk U.S. sensitive personal data that involves bulk human ’omic data, or to human biospecimens from which bulk human ’omic data could be derived.”[3],[4] However, the Final Rules provided exemptions for: transactions that involve regulatory approval data and are necessary to obtain or maintain regulatory authorization of a drug, biological product, or device; transactions ordinarily incident to and part of clinical investigations regulated by the FDA or clinical investigations that support applications to the FDA for research or marketing permits for drugs, biological products, devices, combination products, or infant formula; and transactions ordinarily incident to and part of the collection and processing of clinical care data or post-marketing surveillance data necessary to support or maintain authorization by the FDA.[5]
The FDA Announcement cites “mounting evidence that some of these trials [involving sending American citizens’ living cells to China and other hostile countries] failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries,” and indicates that this practice was made possible by the exemptions for FDA-regulated clinical trials.[6] The FDA announcement continued that the FDA is “actively reviewing all relevant clinical trials that relied on this exemption” and that companies must demonstrate “full transparency, ethical consent, and domestic handling of sensitive biological materials” for any new trials to proceed.[7]
The Final Rules also exempt “transactions conducted pursuant to a grant, contract, or other agreement entered into with the United States Government.”[8] However, The FDA Announcement noted that the FDA is also “working closely with the National Institutes of Health (NIH) to ensure that no federally funded research is compromised by these practices” and that “[a]dditional enforcement and policy measures could be forthcoming.”[9]
Executive Order 14292 was issued by the Trump administration and, among other things, seeks to prohibit federal funding of “dangerous gain-of-function research,” which is defined as “scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility,” conducted by foreign entities, or occurring in countries of concern or in other countries having inadequate oversight to ensure compliance with United States oversight standards and policies.[10] A bill codifying Executive Order 14292 was introduced in the House of Representatives, and is currently under committee consideration.[11]
Through current and future implementation of these executive orders, the FDA is expected to more closely monitor overseas transfer of biological samples from which bulk human ’omic data could be derived in clinical trials and federally funded research.
Editor: Brenden S. Gingrich, Ph.D.
[1] https://www.fda.gov/news-events/press-announcements/fda-halts-new-clinical-trials-export-americans-cells-foreign-labs-hostile-countries-genetic (“FDA Announcement”)
[2] https://www.federalregister.gov/documents/2024/03/01/2024-04573/preventing-access-to-americans-bulk-sensitive-personal-data-and-united-states-government-related
[3] https://www.federalregister.gov/documents/2025/01/08/2024-31486/preventing-access-to-us-sensitive-personal-data-and-government-related-data-by-countries-of-concern#sectno-reference-202.101; 28 CFR § 202.303 (“Final Rules”)
[4] “Human ’omic data” is defined as data related to the following four categories: (1) “Data representing the nucleic acid sequences that constitute the entire set or a subset of the genetic instructions found in a human cell, . . . .” (“Human genomic data”) (2) “Data derived from a systems-level analysis of human epigenetic modifications, which are changes in gene expression that do not involve alterations to the DNA sequence itself. (“Human epigenomic data”) (3) Data derived from a systems-level analysis of proteins expressed by a human genome, cell, tissue, or organism. (“Human proteomic data”) (4) Data derived from a systems-level analysis of RNA transcripts produced by the human genome under specific conditions or in a specific cell type. (“Human transcriptomic data”); and further “excludes pathogen-specific data embedded in human ’omic data sets.” 28 CFR §§ 202.224.
[5] 28 CFR §§ 202.510-511.
[6] FDA Announcement, supra.
[7] Id.
[8] 28 CFR §§ 202.504
[9] FDA Announcement, supra.
[10] https://www.federalregister.gov/documents/2025/05/08/2025-08266/improving-the-safety-and-security-of-biological-research
[11] https://www.congress.gov/bill/119th-congress/house-bill/3677/all-actions
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