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U.S. Biosecure Act Advances with Revised Timeline

WuXi Biologics added to list of biotech companies of concern, now provides U.S. companies until 2032 to find new service providers.

By: Kristin Brooks

Managing Editor, Contract Pharma

On May 15th the U.S. House Committee on Oversight and Accountability voted to approve the BIOSECURE Act, which now goes to the Senate for approval. As the BIOSECURE Act advances in congress that would restrict U.S. business with certain Chinese biotechnology companies, it now provides U.S. companies until 2032 to find new service providers. 
 
The latest revisions to the bill add WuXi Biologics to a list of biotech companies of concern, according to a copy seen by Reuters. Other companies on the list include BGI, MGI, Complete Genomics and WuXi AppTec. These companies provide contract research and manufacturing services for global pharma and biopharma firms. The revised bill was introduced May 3rd.  
 
The bill aims to safeguard personal health and genetic information of Americans from foreign adversaries as well as for U.S. pharma and biopharma companies to reduce their reliance on China for pharmaceutical ingredients and early research services.
 
WuXi AppTec has ended its membership in the BIO Association. Also, WuXi Biologics will no longer participate in the 2024 BIO International Convention. According to BIO, the organization will support the BIOSECURE Act and will work with Congress as this legislation progresses. BIO will work with policymakers on biomanufacturing and distribution capacity and capabilities with respect to addressing drug supply concerns.  

According to Congress.gov, this bill prohibits federal contracting with certain biotechnology providers connected to foreign adversaries, with exceptions.
 
Specifically, the bill prohibits executive agencies from (1) procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern, or (2) entering into a contract or extending or renewing a contract that uses such equipment or service or that will require the direct use of such equipment or services. Those agencies may not obligate or expend loan or grant funds for such purposes.
 
A biotechnology company of concern includes BGI, MGI, Complete Genomics, WuXi AppTec, and any subsidiary, parent affiliate, or successor of such entities, and any entity that
  • is subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary;
  • is involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service; and
  • poses a risk to U.S. national security based on specified activities.
 

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