Key Takeaways
- The FDA is tightening rules to stop American DNA from being sent to labs in China and other adversarial countries.
- Previously, U.S. companies could export biological materials like living cells to China for research, even without informing trial participants.
- The U.S. government is concerned that genetic data could be diverted to China’s military.
- This crackdown follows growing worries about biosecurity and the potential misuse of American genetic material.
FDA Tightens Rules on Exporting American DNA
The U.S. Food and Drug Administration (FDA) announced a major policy change Wednesday to curb the flow of American genetic material to labs in China and other countries considered adversaries. This move comes after years of allowing pharmaceutical companies and research institutions to send biological samples, like living cells, to China for clinical trials.
What Changed? Before this policy shift, companies running clinical trials could export biological materials to China under certain exemptions. This meant that living cells taken from American citizens during clinical trials were sometimes sent to Chinese labs for processing. These cells were then brought back to the U.S. for use in treatments. In some cases, the participants in these trials weren’t even told their cells were being sent overseas.
FDA Commissioner Dr. Marty Makary criticized the previous policy, saying it turned a “blind eye” to the risks of sending American DNA abroad. He emphasized that this practice could expose sensitive genetic data to hostile countries.
Why This Matters The U.S. government has growing concerns that China could misuse American genetic data for military purposes. For example, some Chinese military writings have speculated about the possibility of “specific ethnic genetic attacks,” although experts say this idea remains theoretical.
The crackdown also follows the COVID-19 pandemic, which highlighted the risks of biological research. Wuhan, the city where the virus first emerged, is home to a high-security lab tied to the Chinese military.
How Big Is This Issue? There are thousands of active clinical trials in the U.S. involving cell and gene therapies. These trials often use living cells, which could be sent to labs in China for processing. The American Society of Gene-Cell Therapy estimates there are roughly 8,000 active cell therapy and 1,000 gene therapy experiments ongoing in the U.S.
If these cells fall into the wrong hands, they could potentially be used to develop technologies that exploit genetic information. This has raised red flags among biosecurity experts.
China’s Role in Genetic Research China has become a global leader in genetic research, thanks in part to companies like the BGI Group, the world’s largest genomic sequencing company. Based in Shenzhen, BGI has ties to the Chinese government and military.
The U.S. Commerce Department has blacklisted several BGI affiliates, accusing them of aiding government surveillance and posing a risk of diverting genetic data to military programs.
Some critics worry that American companies outsourcing their research to China might unintentionally be contributing to these efforts.
A Troubling Trend The FDA’s new policy is part of a broader effort by the U.S. government to protect American genetic data. In recent years, the U.S. has enforced stricter export controls on sensitive technologies and biological materials. These rules aim to prevent adversarial countries like China, Russia, and Iran from gaining access to materials that could be used for military or espionage purposes.
The issue has sparked debate among experts. While some worry about the risks of genetic data falling into the wrong hands, others argue that collaboration with foreign labs is essential for advancing medical research.
What’s Next? The FDA’s crackdown on exporting American DNA is a significant step in addressing biosecurity concerns. It also raises questions about how to balance innovation with national security. As the U.S. tightens its rules, companies and researchers will need to find new ways to conduct their work without compromising sensitive data.
For now, one thing is clear: The U.S. is taking a firmer stance to protect American genetic material from being misused by adversarial nations.