Washington has finally figured out that biotechnology is a national security issue. Welcome to the party. The Chinese government has understood this for years, investing aggressively in pharmaceutical research, advanced manufacturing, and the scientific infrastructure that will determine who develops tomorrow's medicines. While Washington was busy congratulating itself on America's historic leadership in biotechnology, Beijing was busy building the competition.
Now comes the Comprehensive Outbound Investment National Security (COINS) Act. Enacted last December, the law gives the Treasury Department authority to restrict certain American investments in technologies that could benefit foreign adversaries. On October 22, Treasury proposed adding biotechnology to the list. The security concerns are real enough. But Washington has a habit of reaching for a regulatory sledgehammer when a scalpel would do.
China is no longer simply the world's low-cost pharmaceutical workshop. Chinese companies are developing innovative cancer therapies, monoclonal antibodies, and other advanced treatments. American drugmakers have noticed, increasingly looking to Chinese developers for promising compounds that can be licensed and brought into global clinical development. This is hardly evidence of American surrender. It's how modern pharmaceutical research works.
Some people in Washington apparently find this troubling. Patients waiting for better treatments may have a different perspective.
The FDA doesn't approve drugs based on the flag flying outside the laboratory. It evaluates safety, effectiveness, and manufacturing quality. A molecule doesn't become scientifically suspect because it was discovered in Shanghai rather than San Diego. And an American company that licenses a promising Chinese-developed cancer therapy isn't necessarily strengthening Beijing's military capabilities. It may simply be doing what pharmaceutical companies are supposed to do: finding better medicines.
None of this excuses genuine national security threats. Sensitive genetic information, military applications of biotechnology, and transfers of strategically important technology deserve serious scrutiny. Some transactions should unquestionably be prohibited. But there is a considerable difference between financing a Chinese military biotechnology program and acquiring the rights to develop a treatment for American cancer patients. Surely Washington can manage that distinction.
The Treasury proposal generally leaves conventional stand-alone drug licensing agreements outside its investment restrictions. That's important, and it needs to stay that way. Equity investments and certain joint ventures raise different questions, particularly when American capital or technology could advance China's strategic capabilities. A licensing agreement, an equity investment, and a joint venture aren't interchangeable arrangements. Pretending otherwise may make for convenient political messaging, but it makes for lousy regulatory policy.
And let's not pretend America's growing dependence on foreign biotechnology happened by accident. China invested heavily in scientific talent, manufacturing capacity, and drug development infrastructure. Meanwhile, American innovators have been wrestling with regulatory uncertainty, reimbursement pressures, and a political environment that too often treats pharmaceutical innovation as a problem to be managed rather than an asset to be encouraged. Beijing didn't create all those headaches. Washington helped.
If Congress wants to reverse that trend, it might begin by making America a more attractive place to discover, develop, and manufacture medicines. Predictable FDA regulatory pathways, sensible reimbursement policies, competitive investment incentives, and stronger partnerships with trusted allies would be a good start. Research laboratories and advanced manufacturing facilities cannot be conjured into existence by congressional press release. They take money, expertise, and time. None of which is supplied by another layer of federal paperwork.
Having spent time inside the FDA, I can assure you that the agency has enough to do without becoming Washington's newest instrument of trade policy. It already has substantial authority to demand credible clinical evidence, inspect foreign manufacturing facilities, and reject applications that fail to meet American standards. Those responsibilities should be exercised rigorously, regardless of where a product originates.
Scientific review should never become a backdoor instrument of geopolitical retaliation.
This matters particularly for patients with ALS, aggressive cancers, and rare genetic disorders. They don't have the luxury of waiting for Washington to get comfortable with its latest industrial policy. Patients deserve rigorous science, not regulatory obstacles imposed for reasons that have nothing to do with the safety or effectiveness of their medicines. A promising therapy should stand or fall on the quality of its evidence, not the geography of its discovery.
Treasury has invited public comment on its proposed biotechnology restrictions. Good. The pharmaceutical industry, patient advocates, and scientific community should take that invitation seriously. Treasury needs to be especially careful about how it defines pharmaceutical technologies. The last thing American patients need is a set of rules so broadly written that promising medical research becomes collateral damage in Washington's fight with Beijing. There are enough obstacles between a laboratory discovery and an FDA-approved medicine without inventing a few more.
Washington can't regulate its way back to biotechnology dominance. Protecting American technology is important, but rebuilding American scientific leadership requires something considerably more ambitious than another set of restrictions. That means making the United States a place where scientists want to work, investors want to invest, and manufacturers want to build. China has spent years doing precisely that. We might consider taking the hint.
America doesn't win the biotechnology race by building the tallest regulatory fence. It wins by developing better medicines, manufacturing them reliably, and getting them to patients faster. National security matters. So does medical progress. Surely Washington can walk and chew gum at the same time.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
