OPINION:
American leadership in biotechnology resulted from decades of investment. It consists of a market-driven system that rewards critically necessary innovation and a regulatory framework built to move science from lab to patient faster than anywhere else in the world.
And for most of the past half-century, our leadership went unchallenged. In recent years, however, that has shifted.
China has made biotech a national priority by dedicating sustained government financing and long-term industrial planning to the industry.
Unfortunately for the United States, it’s working.
China’s workforce claims high rates of advanced degree graduates in STEM disciplines. Over the past decade, the government has cut red tape to streamline review and approval processes and has bolstered domestic patent protections.
China has established the infrastructure needed to take a molecule from discovery to clinical trial 50% to 70% faster than the rest of the world. As a result, it is closer than ever to securing leadership of the global biotech industry.
Since 2015, for instance, the share of early-stage drug programs originating in China has quadrupled, reaching a high of 35% in 2024.
This past summer, the first-ever study originating in China was featured at a meeting of the American Society of Clinical Oncology and its resulting therapy is now under review by the Food and Drug Administration (FDA), a likely preview of many more to come.
Projections indicate that Chinese drugs could make up 35% of FDA approvals by 2040 – a sevenfold increase from the current 5%.
Even without China’s ascent, however, U.S. biotech strength faces mounting risk. New and existing policies from Washington make it increasingly difficult to innovate at home and create unnecessary interventions that the free market could easily resolve.
Federal and state efforts to implement drug price controls stifle investments into research and development. Venture capital-backed rounds of funding for U.S. biotech dropped by over 25% percent from 2024 to 2025.
Needless bureaucracy at the FDA delays early-stage U.S. trials by years, with one recent analysis revealing that FDA effectiveness-review postponements of one to six years cost consumers and producers $4 trillion to $61 trillion in foregone combined value.
Attempts to weaken or reverse critical patent protections discourage Americans’ innovative spirit.
Unfortunately, the newest idea from Washington for countering China’s rise threatens to compound the problem. The Comprehensive Outbound Investment National Security Act (COINS) Act gives the U.S. Treasury Department the power to restrict or block U.S. investment in China and other countries of concern for sectors it considers security risks.
The legislation was conceived to target technologies related to artificial intelligence, super-computing and others, but U.S. officials are now floating the idea of adding biopharmaceuticals to the list of affected industries.
Doing so would only aggravate matters by cutting American companies off from the licensing deals, joint research and vendor agreements that allow U.S. firms to discover, develop and deliver treatments built in part on early-stage compounds developed in China.
In other words, China would be handed sole control of those new treatments and life-saving therapies, threatening to delay or outright restrict U.S. patient access.
This is not the way to win the race against China. Instead, the U.S. must lean into what already sets our nation apart: a free-market spirit that promotes and rewards innovation unburdened by unnecessary government red tape.
President Trump has already shown that this kind of overhaul is possible. His permitting reform efforts cut through years of regulatory sprawl to get energy and infrastructure projects moving again. The same can and should be done for America’s biopharmaceutical industry.
In June, the U.S. Department of Health and Human Services (HHS) launched “Operation TrialBlazer,” a new initiative to strengthen American leadership in clinical research, fast-track breakthroughs and guarantee patient access to cutting-edge therapies.
The FDA, acknowledging China’s gains in biomedical research, is now soliciting feedback through a request for information on a promising pilot program intended to streamline the process from drug identification to first-in-human study.
That’s good news, but leaders must further prioritize modernizing the FDA so that safe trials are counted in months rather than years, strengthen IP frameworks and increase investment incentives to drive more R&D.
Well-intentioned attempts to protect national security interests must be precisely targeted to specific threats, not applied so broadly as to undercut American biopharmaceutical competitiveness or leave patients unable to access the treatments of tomorrow.
Beijing isn’t slowing down to wait for Washington. Counterproductive efforts like banning outbound biotech investment won’t speed America up. It’s time for the U.S. to accelerate efforts to cut red tape and step on the gas.
The only way to beat China is to outcompete it.
• Jeffrey Mazella is president of the Center for Individual Freedom.
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