The United States' long-standing dominance in biotechnology is eroding. China now runs more clinical drug trials than the U.S., and its share of global drug-development work has climbed sharply over the past decade.
This isn't just a commercial issue. The nations that can discover, develop, and bring to market the next wave of medical breakthroughs will hold a major advantage in economic competitiveness, national security, and public health. But the U.S. still has a chance to outpace China in one promising field: regenerative medicine—treatments using engineered tissues, biomaterials, and gene editing to repair or replace damaged cells, tissues, and organs. While China is active here, the U.S. market for these technologies is projected to hit $90 billion by 2030.
To win that race, America needs a regulatory environment that rewards innovation and lets companies compete fairly globally. That means the FDA must act swiftly and predictably, giving innovators the certainty they need to develop products that help patients.
The cost of regulatory paralysis isn't theoretical. Consider Regenative Labs, a Florida biotech firm based in Pensacola. It makes products from donated human birth tissue that have benefited patients and physicians across the U.S. But the company can't sell overseas because the FDA hasn't ruled on its applications for a Certificate of Foreign Government—a document required for foreign sales. For three years, since the Biden administration, Regenative has been stuck in bureaucratic limbo, waiting for a decision that federal law says must come within 20 days.
While the FDA stalls, foreign rivals unburdened by such red tape are grabbing market share abroad. Regenative could simply move its operations offshore, but it wants to stay in Florida, where it started. An American company with American-developed technology is being held back from expanding its workforce—not for lack of demand, but because bureaucrats have ignored their congressional mandate to act.
This case is about more than one firm's export papers. It shows how regulatory inaction can throttle biotech growth, slow domestic manufacturing, and weaken America's position in one of the world's fastest-growing industries. Every delayed decision is a missed opportunity for U.S. workers, for domestic production, and for the homegrown companies developing tomorrow's medical innovations.
The broader stakes are clear: biotechnology is becoming a defining industry of the 21st century. The countries that lead in medical innovation will shape the future. The U.S. has been the world's standard-bearer in this arena, but that status is slipping. China is actively aiming to overtake us. We can't take our leadership for granted—each time unnecessary bureaucracy hampers American innovators while competitors abroad move ahead, we risk surrendering a strategic advantage built over half a century.
American biotech also has a global reach that matters for national security. U.S.-developed treatments could help hundreds of thousands of service members, military families, and other Americans living overseas. Blocking those innovations from reaching them is a disservice to those who serve.
Making America healthy again isn't just about discovering new cures—it's about creating the conditions for innovation to reach patients. Our regulatory system must give companies the clarity they need. Transparency and timely action from agencies like the FDA are as vital as any research breakthrough to advancing health and preserving U.S. biotech leadership for years to come.
David Mansdoerfer, former Deputy Assistant Secretary for Health, is an adjunct professor of health policy and politics at Pepperdine University's School of Public Policy.
