The United States has long been the global leader in biomedical innovation, a position built on rigorous safety standards, top-tier scientific talent, and strict regulatory oversight. But that leadership is eroding, and with it the safety net that American patients rely on. Former Rep. Mimi Walters (R-Calif.) argues that Washington must act now to reverse the trend.
For decades, the U.S. funded the majority of the world's biomedical research. Today, that share has dipped below half for the first time in over twenty years, as capital and research activity migrate overseas. China's biotech sector, in particular, has expanded at an unprecedented pace. A decade ago, Chinese companies accounted for just 17 percent of new drugs entering global clinical trials; today, that figure stands at 46 percent.
This shift is not merely an economic concern—it is a direct threat to patient safety. China's regulatory and manufacturing systems do not meet the standards Americans expect. The 2008 heparin crisis, where contaminated blood thinner ingredients from China killed 81 Americans and injured hundreds more, remains a stark reminder of the dangers of outsourcing critical drug production to weaker oversight regimes.
Data shows that foreign-made generic drugs are nearly twice as likely to cause severe adverse events compared to their American-made counterparts. With roughly 20 percent of the ingredients in essential medicines now sourced from abroad, a growing portion of what ends up in U.S. medicine cabinets is produced under standards that cannot be fully verified or enforced.
Walters, who served on the House Energy and Commerce Committee, emphasizes that biomedical leadership is a matter of national interest. “Innovation and safety are not opposing forces,” she writes. “They are partners.” Every breakthrough, from insulin to chemotherapy, has been built on rigorous, evidence-based research, including carefully regulated animal studies that verify safety before human trials. Those methods are now under threat as federal agencies push to phase out animal research without validated alternatives.
Congress does not have to choose between embracing new scientific tools and preserving patient safety. Walters argues that any transition must be tied to validation milestones, not arbitrary dates. Lawmakers should require the FDA and NIH to publish clear criteria that new methods must meet before replacing existing ones. Pairing that with incentives to keep research and manufacturing on American soil would help secure the nation's biomedical future.
The stakes extend into every hospital and home. Restricting research in the U.S. would not eliminate it—it would simply relocate it to laboratories in China that American regulators cannot inspect and American families cannot question. “We would not have eliminated the research,” Walters warns. “We would have eliminated our ability to oversee it.”
Congress faces a choice that is not partisan. By tying timelines to validation and offering real incentives for domestic production, lawmakers can protect the science that underpins tomorrow's cures. As Walters concludes, “Our economy, our families, and our future cures depend on getting this right—and on keeping the science that protects them made in America.”
