FDA to Review Clinical Trials That Utilize Overseas Cell Processing

The Food and Drug Administration announced last week that the agency will immediately review new clinical trials that involve sending living cells to facilities overseas for genetic engineering and reinfusion into patients in the United States.

The review comes in response to concerns that some FDA-regulated clinical trials may not have adequately informed participants about the international transfer and genetic manipulation of their biological material, which the agency believes may have exposed personal genetic data to misuse.

FDA officials noted that a regulatory exemption implemented by the Department of Justice in April permitted the transfer of biological samples to foreign facilities under certain conditions. As part of the review, FDA will “require companies to demonstrate full transparency, ethical consent and domestic handling of sensitive biological materials.”

The agency is also coordinating with the National Institutes of Health to assess the extent of these practices in federally funded research.