- - Saturday, February 13, 2021

Believe it or not, there are urgent health care issues facing our nation that are not exclusively pandemic-specific. As we move forward with a new administration in Washington, our thinking, planning and execution of a whole host of health care opportunities must be informed by the tough and valuable lessons we have learned (but are still largely ignoring) from our battle against COVID-19.  

• The urgency of coordination

The current problems we’re dealing with relative to vaccine roll-out remind us how much we have learned — and how little we have absorbed. If, in March of 2020, I had predicted we’d have a well-stocked COVID-19 armamentarium replete with diagnostics, therapeutics and vaccines by the end of the year — I would have been accused of wishful thinking. 

COVID-19 Urgency Lesson #1: A key facilitator of velocity is broad participation. We can accomplish great things quickly when we work together. Our health care ecosystem, including the biopharmaceutical industry, academia, government health agencies, manufacturing logicians, hospitalists, health care workers, pharmacists, patients and caregivers all helped to accelerate our understanding of the virus, how to mitigate it, flatten the curve and save lives. Imagine what we will accomplish working together more regularly on a wide array of opportunities to improve the human condition? 

• The urgency of innovation



Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap. The complicated and conflicting dynamics of politics, perspectives on health care economics, of friction between payers, providers, manufacturers and regulators, the battle for better patient education, and the need for a more forceful and factual debate over the value of innovation all create the need for a more balanced and robust debate. 

COVID-19 Urgency Lesson #2: Innovation is never as easy as it looks. As any scientist will tell you, innovation happens step by step, one incremental innovation at a time. Innovation is hard – but urgent. Beyond COVID-19, we must also embrace innovative technologies for medical records and prescribing. We need innovative clinical trial designs and molecular diagnostics so that we can develop better, more personalized medicines faster and for far less than the current $1 billion-plus delivery charge. We need innovation in access and reimbursement policies. 

• The urgency of 21st-century FDA regulatory policy

The status quo is a harsh mistress. Too many people want to go back to the way things were. But there’s no turning back. While scientifically robust standards and practices are the twin underpinnings of regulatory science, they are by no stretch of the imagination etched in twin tablets by divine fire. 

The most potent way medicines regulators can enable innovation is by being a partner in advancing new approaches to both drug development and regulatory science. What does “safety” mean? How is it measured? What is its role in the benefit/risk proposition? Who is its arbiter and guardian? What are the ground rules? What are the pitfalls and opportunities presented by new technologies? Posing the tough questions is a crucial first step.

COVID-19 Urgency Lesson #3: The FDA can either be a sea anchor or an accelerator of innovation. A universal truth from human behavioral science is that those doing the work are uncomfortable when the ground rules change. The good news is that the FDA’s recognizes it must be a leader in regulatory science — the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products — by dint of true expertise rather than for simply “being the FDA.” COVID-19 has reinforced the FDA’s understanding that laying claim to the regulatory gold standard is a moving target.

• The urgency of science

When it comes to health care writ large and regulated health care technologies specifically, quality is a sine qua non. We’ve learned a lot from COVID-19. How are we going to share that knowledge and maximize it to the fullest potential?

COVID-19 Urgency Lesson #4: Without science, nothing happens. Science mustn’t be silenced or siloed. Science must be collegial, intramural and transnational. Science can be expedited but not rushed. Science cannot be politicized. And science must be trusted by all constituencies from highly degreed academics and regulators to family doctors and patients. Trust counts. We need not look any further than the fact that so many Americans do not trust the FDA process sufficiently to get vaccinated against COVID-19. 

When it comes to placing blame for the devastation of COVID-19, laying it all at the feet of Donald Trump is facile and dangerous. We were as a nation, unwilling, unable and unprepared. This must never happen again. 

Our battle against COVID-19 will be judged by history, but a brutally honest and introspective analysis of our current successes and failures must act as a roadmap to protect future generations of Americans.

Nobody said it was going to be easy.

• Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a visiting professor at the University of Paris School of Medicine.

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