Scott Gottlieb’s Post

I completely agree Scott. Sacrificing domestic innovation leadership as a matter of policy is a losing proposition scientifically and economically. Thanks for spotlighting it.

Given the existential threat that China poses to US drug development the least we can do is get out of our own way. The FDA puts up barriers that dont exist in similar western regulatory environments like EU, UK, etc. patients suffer when the US is more bureaucratic than Paris & London

This is an example of leading thought and a call for adaptive responses that are needed now ... not hand-wringing. That said Dr. Gottlieb, I believe you overlook the deep reservoir of highly responsive and agile small biotech companies at the heart of the USA biomedical industry; these small organizations are focused and far better adapted for early drug development efforts, as compared to academia, which demands a 60-70% overhead to engage and a year of 'administration' to start.

Thanks for great points Scott Gottlieb. Especially on faltering discovery engine work carried mostly by academia and simplifications needed to start early trials. Erosion of the fundamental science over past years and current acceleration of that process are inevitably leading to limited clinical pipeline. Question remaining is how we increase funding for basic academic research including sponsored by NIH, NSF and link that to main business beneficiaries -Pharma.

U.S. leadership in biomedicine is as strategic as semiconductors or AI. In addition to some some of the points you make here Scott, sustaining that edge also requires modernizing regulation with the tools we already have—AI, advanced data platforms, and digital trial infrastructure—could make preclinical research faster, smarter, and more accessible to academic labs. Policy reform that embraces these technologies would reduce costs, expand participation, and strengthen the U.S. discovery engine. If we treat biomedicine as the strategic asset it is, collection public/private action can ensure that the U.S. sets the standards for both science and ethics in the decades ahead.

Thank you for the comprehensive and thoughtful article on this critically important issue. The American people need to consider that the majoruty of new drug candidates and/or the understanding of the underlying biology behind them comes from academic research and not pharmaceutical companies. As we curtail basic research we will inevitably slow down the development pipelines in the private sector that provide drugs at large scale for late stage trials and supply of commercial products. The bottom line is that reducing funding of academic labs and the NIH (where both research and clinical trials are top priorities), we de facto result in the loss of our preeminent position as the world’s greatest biomedical research and development engine. As a 40-year veteran of the biotechnology industry, the ramifications of these disastrous policies are obvious. This is the nation that launched the recombinant DNA revolution, the polymerase chain reaction, and the biotechnology industry. This is the home nation of groundbreaking antiviral agents for treatment of HIV infection and, for the first time in human history, the eradication of a viral infection, Hepatitis C. Immunotherapy was born here as well

Yeah we should force universities to yield >75% ownership to the investigators and postdocs themselves and not 5% or less, while keeping ownership of the remaining 95%. Universities don’t need more regulatory capture on research - they need less. In the IP landscape they have more than enough control and this hasn’t yielded incentives to translate because of the rest of the infrastructure of how research $$$ is protected and allocated.

There are certified groups that can do 510(k)s already and work on other products These need to be more visible

To pursue that path, there needs to be safeguards and an infrastructure to track both safety and efficacy. The FDA may take longer than we’d like to get a drug or biologic on the market, but they have infrastructure in place. My alternate suggestion is to appoint approved and accountable notified bodies as intermediaries to execute FDA infrastructure.

Thank you, as always, Scott, for an important and timely perspective. Sustaining U.S. leadership in biomedicine isn’t just about science, it’s about strategic independence, economic resilience, and patient impact. As Scott Gottlieb points out, we risk ceding ground to China unless we lower barriers to early-stage discovery, empower academic innovators, and modernize regulatory approaches. If we want to remain the global leader, we need policies that both preserve the FDA’s strength in later-stage rigor and unlock efficiency in preclinical and phase 1 research. That balance will ensure patients get safe, effective, and life-changing therapies while keeping our biomedical ecosystem innovative and competitive.