FDA crackdown on cells across borders

The Food and Drug Administration of the United States (FDA) examines clinical trials that export “living American cells” to foreign laboratories, including those in China and other “hostile countries”, invoking concerns about data security. This action, communicated by the press release, aims to stop the clinical trials regulated by the FDA which involve the shipment of biological equipment – including DNA – for genetic engineering and the subsequent return to the United States for infusion. If this rule was imposed, this would affect international collaborations of gene therapy and genetic therapy with contractual research organizations. In a FDA podcast published on June 19, the FDA commissioner Martin Makary mentioned the treatment of T lymphocytes of chimerical antigen (CAR-T) receptors as a type of treatment that could be affected by this rule.

The Liberation of the FDA criticizes the Biden administration for having allowed the use of sensitive information from the Americans, and says that it seeks to implement the decrees 14117, by President Joe Biden, and 14292, by President Donald Trump, the last one who aims to reduce the “Search for dangerous gains. ”