WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has initiated an immediate review of clinical trials involving the international transfer of Americans’ living cells for genetic engineering and subsequent infusion back into patients in the United States. The agency is addressing serious concerns that trial participants were unaware of these transfers or the potential risks to their genetic data.
Evidence suggests that some trials failed to inform participants about the handling of their biological materials and exposed sensitive genetic information to foreign entities, including adversarial governments. This practice was facilitated by a December 2024 data security rule finalized under the Biden Administration. Although this rule restricted the transfer of sensitive data to rival nations, it included a broad exemption allowing U.S. companies to send biological samples, such as DNA, to countries like China for processing, even when entities with ties to the Chinese government were involved.
“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” said FDA Commissioner Dr. Marty Makary. “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.”
The FDA will now require companies involved in these trials to provide full transparency about their processes, obtain proper informed consent, and ensure domestic handling of biological materials. New clinical trials failing to meet these standards will face suspension.
The agency is also working alongside the National Institutes of Health (NIH) to ensure federally funded research adheres to ethical standards and safeguards national security. This effort aligns with Executive Orders 14117 and 14292, which aim to protect Americans’ sensitive biological data from misuse by foreign adversaries and ensure compliance with secure laboratory practices within the United States.
Enhanced enforcement and additional policy measures are expected as part of this comprehensive initiative to reestablish public trust and uphold ethical standards in biomedical research.
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