China’s rapid rise in biotechnology has prompted a familiar response in Washington: impose new restrictions on American companies doing business there. But blocking where American companies can invest will not remove the regulatory obstacles that slow medical research at home. A better response starts with giving American researchers more freedom to develop treatments while granting patients more opportunity to pursue them.
The proposed Biotech Investment National Security Act would expand the Comprehensive Outbound Investment National Security Act (COINS) to cover certain pharmaceutical licensing deals, joint ventures and equity investments involving Chinese biotech firms. The legislation would add biopharmaceutical development to the sectors subject to increased federal scrutiny, restricting the ability of U.S. companies to develop and take to market new treatments. Congress should reject that expansion and instead focus on cutting the red tape that slows medical research at home.
China’s growing role in drug development deserves serious attention. A Georgetown University analysis found that China accounted for just 8% of the world’s early-stage drug-development programs in 2015, compared with 48% for the United States. By 2024, China’s share had surged to more than 32%, while the U.S. share had fallen to just over 37%. Those figures underscore the need to make America a more attractive place to develop new medicines.
Speed is part of that competition, and federal regulators acknowledge that America has a problem. The FDA says first-in-human clinical trials can take up to two years to complete in the United States. Comparable trials proceed much faster in China and Australia. In September, the agency announced the final design of an expedited pilot intended to shorten the path from identifying a promising drug to beginning human trials.
New restrictions on overseas investment would leave those domestic obstacles in place. They could also narrow the partnerships American companies use to develop promising treatments without making research here any faster. If lawmakers want more medical innovation in the United States, they should make it easier for that work to be done here.
Right to Try offers a successful model for removing regulatory barriers while preserving safety. Developed by the Goldwater Institute, the reform gave terminally-ill patients who had exhausted approved options a pathway to investigational medicines that had completed Phase I clinical trials but had not yet received full FDA approval. It expanded patients’ freedom to work directly with willing physicians and manufacturers, becoming law in 41 states before Congress enacted a federal version in 2018.
The same principle should guide efforts to reform America’s overburdened biotechnology regulatory system. Right to Try challenged the assumption that patients must wait for the government’s full approval process to run its course before pursuing a treatment that might help them. It put greater authority in the hands of patients and their doctors while preserving informed consent and voluntary participation. Goldwater’s Right to Try 2.0 would extend that freedom to patients seeking investigational treatments tailored to their genetic makeup—providing Congress with a starting point for a broader effort to remove unnecessary barriers to developing new medicines and getting them to patients.
America’s response to China’s biotechnology rise should reflect the same confidence in freedom that made Right to Try possible. Giving researchers more freedom to develop new medicines would strengthen America’s ability to compete and give patients more opportunities to pursue potentially lifesaving treatments.
Victor Riches is the President and CEO of the Goldwater Institute, leading the Institute’s efforts to help people in all 50 states live freer, happier lives.
