Regulatory hurdles stall biotech innovation and national security in the U.S

In the United States, the biotechnology sector faces significant challenges due to outdated regulatory systems that threaten the country's innovation and competitiveness. The case of AquaBounty Technologies, which developed the AquAdvantage Salmon, the first genetically engineered fish approved for human consumption by the Food and Drug Administration, illustrates these hurdles. This innovation emerged amidst a complex regulatory environment that serves as an urgent reminder of the implications for U.S. national competitiveness. Additionally, Oxitec's genetically engineered male Aedes aegypti mosquito underwent years of regulatory review before being classified as a biopesticide and transferred to the Environmental Protection Agency in 2017. These protracted regulatory processes create national security concerns and highlight the imperative for reform. The National Security Commission on Emerging Biotechnology has emphasized the need for legislative changes to support innovation in biotech and other sectors. This aligns with broader efforts by Congress to address strategic vulnerabilities in emerging technologies such as biotechnology, cybersecurity, and artificial intelligence. Businesses and the government must collaborate more effectively to streamline regulatory processes that enable timely innovations. Such collaboration can enhance the nation’s economic prosperity and competitiveness on a global scale. International rivals, particularly from countries like China, are quickly outpacing U.S. companies, leveraging their own more favorable regulatory environments to gain a competitive edge in global biotechnology. Consequently, U.S. companies are urged to improve their understanding of the regulatory processes while lobbying for the necessary reforms that could enhance their innovation capacities.