Regulatory Reform To Boost U.S. Innovation And National Security

Forbes

24-04-2025

As the U.S. seeks to maintain its global competitiveness in sectors like biotechnology and infrastructure, regulatory reform will play a critical role in shaping that success. As the former President and Chief Operating Officer of Intrexon, a biotechnology company focused on health, energy, food, and the environment, I have personal experience with the challenges faced by the private sector. AquaBounty and Oxitec are two companies that faced an exhausting experience in achieving regulatory approval for their groundbreaking products. While the federal government is making progress and appropriate risks must be managed, these challenges demonstrate how outdated regulatory systems continue to threaten innovation and competitiveness.
AquaBounty developed the AquAdvantage Salmon, the first genetically engineered fish approved for human consumption by the Food and Drug Administration (FDA). The fish was engineered to grow in half the time of a wild Atlantic salmon and with one-third of the food. The AquAdvantage Salmon was a significant innovation, and the United States biotechnology community led the world in its development. Although FDA scientists deemed the AquAdvantage Salmon fit for human consumption early in the review process, the agency did not grant approval until November 2015—more than two decades after AquaBounty began its initial research and regulatory submissions in the 1990s. Despite finally reaching U.S. stores in 2021, AquaBounty announced in December 2024 that it would cease fish farming operations, citing insufficient liquidity after over a year of unsuccessful efforts to raise capital. This outcome and a challenging regulatory environment serve as a wake-up call for U.S. national competitiveness and innovation.
Similarly, Oxitec developed a genetically engineered male Aedes aegypti mosquito. When released, this non-biting male mosquito mates with the wild female mosquito, and the offspring do not survive. The Aedes aegypti mosquito causes the transmission of dengue, Zika, chikungunya, and yellow fever. Regulators were unprepared for this type of biotech innovation, which resulted in a misaligned and unnecessarily long review process. As a result, the Oxitec mosquito was classified as an 'animal drug' with regulatory oversight from the FDA. Oxitec's genetically engineered Aedes aegypti mosquito underwent several years of regulatory review by the FDA before being reclassified as a biopesticide and transferred to the Environmental Protection Agency (EPA) in 2017. Subsequently, the EPA approved an Experimental Use Permit in May 2020, leading to field trials in Florida and Texas in 2022. This reclassification and inefficiency underscore the regulatory challenges biotechnology and other innovative companies face within the U.S. regulatory framework. The regulatory framework must be improved for innovative companies to compete in the global market. This challenge is a national security concern.
Like earlier commissions on cybersecurity and artificial intelligence (which enhanced national security strategy), Congress established the National Security Commission on Emerging Biotechnology (NSCEB). The commission emphasized that biotechnology is central to national security, public health, and economic competitiveness. As the NSCEB warns, China has made biotechnology a national priority for the past two decades, positioning itself ahead of the United States. This concern is echoed in a recent Forbes article emphasizing the urgency of reclaiming America's biotech edge. The NSCEB recommends a minimum investment of $15 billion over the next five years to support domestic biotechnology research and development. As a military leader with biotechnology experience, I know there are several areas where biotech can significantly impact our national security preparedness. These priorities demand a modernized approach—one that anticipates future threats and removes outdated barriers.
I currently serve as a strategic advisor to Ginkgo Bioworks, a publicly traded biotechnology company. During the tragic events of 9/11, I was the senior military officer in the National Military Command Center in the Pentagon, where we monitored the most significant threats to the nation.
In the late 1930s, the U.S. Army developed radar to track enemy aircraft. Today, we need a similar system to detect biological threats. As we saw with COVID-19, pathogen spread was discovered only after people had become ill. As Matthew McKnight, General Manager of Biosecurity at Ginkgo Bioworks, stated, 'The earlier you detect, the faster you nip something in the bud.' He leads a team building a 24/7 detection system for hazardous viruses and pathogens. This biological radar, which I previously discussed in a Forbes article on innovation and biosecurity, is designed to provide early warnings and enable faster responses before outbreaks spread. This program enhances national security by enabling early detection of biosecurity threats and helping the U.S. remain competitive with China, just like cybersecurity and AI.
While U.S. biotechnology companies navigate a challenging regulatory process, Chinese companies like BGI have expanded their global footprint. During the COVID-19 pandemic, BGI partnered with over 180 countries to provide timely detection and intervention, including the establishment of testing laboratories. BGI's extensive international partnerships bolster its scientific capabilities and position it to influence global health organizations and policy. This strategic positioning highlights the long-term competitive implications for U.S. and other international biotechnology companies. Scaling biotechnology infrastructure is not just a commercial advantage—it is a geopolitical one. Moreover, these challenges extend beyond biotechnology.
In July 2012, President Obama announced the "We Can't Wait' initiative to expedite the deepening of the major East Coast ports to accommodate larger post-Panamax ships. The Savannah Harbor Deepening Project, authorized by Congress in 1999, faced an 18-year delay due to bureaucratic complexities and interagency disagreements.
As Chief of Engineers and Commanding General of the U.S. Army Corps of Engineers, my team and I were directly involved in efforts to move this project forward. Despite bipartisan support, progress was stalled for years due to misalignment among federal agencies on priorities. I saw firsthand how even urgent, nationally significant initiatives can be slowed by the regulatory process. Yet, after years of coordinated effort, the federal government finally approved the start of construction. That hard-won progress is a testament to persistence and collaboration—but also highlights how regulatory inefficiencies can delay essential infrastructure projects and undermine national competitiveness.
The federal government can better support innovation and economic prosperity by improving its regulatory process, whether it is biotechnology, infrastructure, or other business sectors. The FDA, EPA, and U.S. Department of Agriculture have made efforts to assist biotechnology developers navigate the regulatory landscape, yet much work remains. Part of the challenge is the lack of accountability and authority to move the regulatory process along. Public companies are held accountable by their shareholders, and quarterly earnings calls allow for discussion of progress on key initiatives. While the U.S. Congress can hold hearings to monitor progress, too many agencies are involved in decision-making with no apparent authority when agencies disagree. That was one of the challenges with the Savannah Harbor Deepening Project. There are years of back-and-forth discussions and collaborations to find common ground. Accountability is essential.
Additionally, businesses must understand how to work within the federal government. The federal government has many good people who have implemented processes to mitigate risk. Businesses with team members who have federal government experience can help navigate the regulatory process. The federal government and companies must learn from each other.
Regardless of the industry, the National Security Commission on Emerging Biotechnology called for reforms addressing the challenges similar to those that I have personally encountered and highlighted in this paper. Some of these reforms include modernizing regulatory frameworks, investing in national biosecurity infrastructure, and making strategic investments. The country needs top-down (government-led) and bottom-up (business-led) partnerships to better understand the challenges and accelerate regulatory progress. Establishing clear timelines, acknowledging defined authority, and fostering accountability in regulatory decision-making are imperative to prevent prolonged delays while managing risks. Such regulatory reforms are essential for the United States to sustain its leadership in innovation and drive the future of biotechnology. Leaders in business and government must work together to modernize our approach—because America's ability to innovate, compete, and lead depends on it.