On September 9, 2024, the House of Representatives passed the BioSecure Act. The BioSecure Act is legislation that seeks to prevent the U.S. government from obtaining services or equipment from a “biotechnology company of concern” that is owned or operated by a foreign adversary that poses a threat to US national security (i.e., China, Cuba, Iran, North Korea, and Russia).  

The BioSecure Act specifically names BGI, MGI, Complete Genomics, WuXi AppTech, and WuXi Biologics as companies of concern.  However, there is room in the Act to permit additional companies to be added to the list in the future.  The Act also prohibits federal grant recipients from using or purchasing equipment from a “biotechnology company of concern”.

If the BioSecure Act passes and becomes law, use of the listed biotechnology companies of concern will be restricted and a list of restricted companies will be published.  Stay tuned for updates in this rapidly changing landscape and how the BioSecure Act may affect the development, registration, and marketing of drugs, biologics, and medical devices in the US.