1 week Ago By Joe Lonsdale
For decades, the United States has led the world in biotech and pharmaceutical innovation. But our dominance is now at risk: not from external sabotage, but from our own regulatory sclerosis. While we drown breakthrough-science in red tape, China has a laser-like focus on speeding up scientific progress and adopting new innovations.
China has embraced CRISPR gene editing , leapfrogged the West in cell therapy, developed sophisticated animal models and rapidly expanded its biotech exports from near-zero in 2016 to nearly 30% of new assets in the world today. Capital is following suit, with dollars pouring into Chinese biotech assets, responding to a regulatory environment that’s more permissive of experimentation and progress. This is not theoretical.
It’s déjà vu: We have watched this story unfold before, across semiconductors, telecommunications, energy and manufacturing. If we don’t course-correct, we will cede the biotech future to China — and the Chinese Communist Party. That means not just offshoring high-skilled jobs, but becoming dependent on an adversary for critical medicines and biological manufacturing.
Competition is a positive motivating force, but there are other reasons to support innovation in the United States — regardless of what China does or doesn’t do. For the health and longevity of the American people, novel medicines that eventually go generic are the most deflationary part of the medical system. Overall health-care costs are dramatically lower if patients have an array of great medicines — an important priority given our $2 trillion budget deficit.
To do this, the Food and Drug Administration needs an innovation prescription. Here’s how its treatment can begin. First, curb burdensome regulations to accelerate drug development.
Speeding clinical trials must become a first-class FDA priority. Every day wasted on regulatory sclerosis is a day a patient loses forever. Accelerating trials isn’t just smart — it’s essential if America wants to stay ahead globally, cut costs, and rapidly separate breakthrough therapies from failures.
Faster trials reward bold innovators and, most importantly, save lives. The FDA must recognize speed as an important goal of clinical research — and that sometimes, speed should win out against other factors. FDA guidance for pharmaceutical companies should require a cost-benefit analysis that includes time as a factor in any clinical trial, accounting for the harm done to patients deprived of a novel medicine while waiting for a trial outcome.
Next, reform approval rules to allow patients access to more medicines. Today’s FDA is so concerned about patient safety regarding drugs, devices and treatments that it denies access to care patients deserve. Millions might be alive today if the FDA had approved treatments faster, or with a greater degree of risk appetite.
An agency dedicated to expanding human lifespan must tailor rare-disease treatment approvals to disease prevalence, rethink the core drug-approval framework and increase the number of groups that can say yes (rather than veto) an approval. For ultra-rare diseases, FDA’s shortcomings and unreasonable trial size demands leave the field underfunded and underinvested. An immediate fix is to issue guidance that no trial for a rare disease should require more than 1% of the relevant population, ensuring a rapid path to approval and commercial incentive to get these therapies out to patients.
Furthermore, competition should diversify drug-approval pathways. The current system relies on a single center within a single gatekeeper: the FDA. Its centralized authority leaves no room for dissenting scientific views or alternative models of risk tolerance.
Patients are held hostage to the judgment of a single bureaucratic body. Just as the Defense Department uses elite Special Operations teams to pioneer new capabilities, the Department of Health and Human Services should create high-agency “SWAT teams” that experiment with novel approval models, monitor outcomes in real time using consumer tech like wearables and remote diagnostics and publish findings transparently. Let the best frameworks rise through internal competition — not by decree, but by results.
Finally, improve drug manufacturing and medical resilience nationwide. Many Americans depend on crucial drugs, from anesthetics used in surgeries to insulin for diabetics. Yet the United States itself has become ever more dependent on drug imports to ensure our health and well-being.
Other countries, particularly China, heavily subsidize their medical manufacturing and enact trade barriers to maximize it. HHS must undertake significant steps to harden America’s drug supply, boost US drug manufacturing and development and step in stop any further medical offshoring. Bold leadership can catapult the US back into the lead for biomedical and biological innovation — but it requires standing up to an internal bureaucracy that has “always done it this way” and resists competition or major change.
That’s something no FDA or HHS leader has managed to do in recent memory. President Donald Trump has brought some great minds and courageous leaders to these critical agencies , people willing and eager to rethink how they function. Millions of lives, and the world’s greatest engine of biotech innovation, hang in the balance.
Joe Lonsdale is the co-founder of Palantir and managing partner of 8VC. Adapted from the Joe Lonsdale Substack..
