It's now time to win the recovery battle by executing sound, combined state and federal programs for each of your states.

America’s full recovery will not proceed without great uncertainties and great risks. We want to help you to reduce (and even eliminate) some of those risks.

BOSTON, MASSACHUSETTS, UNITED STATES, April 22, 2020 /EINPresswire.com/ -- Dear Governors of Our 50 States,

Coronavirus is an insidious disease. It operates most of the time using stealth. Worse, it turns many Americans into hidden – often unknown even to themselves – ticking time bombs.

Fortunately, the tide has just turned, so it's now time to win the recovery battle by executing sound, combined state and federal programs for each of your states. The foremost goal here will be to get YOUR American workers back to work efficiently, effectively, and most of all safely.

KEY STRATEGIES

To achieve maximum safety, here are two key strategies used in my teammates’ and my plan: First, to move swiftly but stepwise in three logistical phases that mirror the President’s three organizational phases, but we published first. To facilitate this, we use what we call a “double sanctuary” approach: one well-kempt virus-free sanctuary at home and the other at work. Second, to use in strict coordination, across the US, only the very best-in-the-world massive-testing tool, initially and especially when our program peaks at 100 million tests per day, every other day for five days.

Only by using the soon-to-be-launched “very low cost, fully at-home virus-antibody-detection test kits” can you assure that you accomplish this goal. And, then only if you use the test kits in a highly distributed and massive way. Everything must come together to create an organized and thoughtful “Massive-Testing System” for YOUR state. Using our plan, this will be a system capable of smoothly and fully integrating with the President's plan. Indeed, it would make his plan far safer.

THE PLAN

My and my teammates’ plan, does this, best. First, it helps you to achieve this safely back-to-work goal quickly, starting now. The start-gun for launching execution of your Program and its system will go off just as soon as one or more of the several very low cost, fully at-home (and fully at-work) test-kit developers receives FDA Emergency Use Authorization (EUA) clearance to launch AND it raises sufficient funds to launch some three million test kits. Lead time here is likely to be four weeks from today, if you and other funders and the FDA proceed quickly.

This money might be raised from a smart combination of direct federal, state, and employer funding sources, in the form of grants or contracts. The new funding will be used to execute, in series, the three-, ten-, and 30-million-unit manufacturing and distributing contracts each top test-kit developer now has, or very soon will have, in place.

THE GOVERNORS OF OUR 50 STATES NOW HAVE EXCEEDINGLY SERIOUS ROLES TO PLAY

Each of you, along with the President and the US FDA, must now guide us back home again. You each bear that burden and that privilege. America’s full recovery will be difficult, scary, and expensive, and it will not proceed without great uncertainties and great risks. In this Open Letter, we want to eliminate some of those uncertainties and help you to reduce (or even eliminate) some of those risks.

MY BACKGROUND

I am a technologically savvy former FDA leader, Harvard faculty member, and senior executive in the health policy, management, and regulation field. I am also an FDA former principal deputy commissioner, where I co-led the last major internal reform of the FDA, and a Harvard former health policy and management faculty member. At Harvard, I taught courses that included assessments (both plus and minus) of FDA policy and I also served as editor-in-chief of a healthcare-related academic journal.

THE INFECTIOUS DISEASE DETECTION TECHNOLOGY I HAVE ADVOCATED SINCE 1987

Since 1987, during my service as FDA Principal Deputy Commissioner, I have before both public and private leaders in the US and around the world advocated better development, regulation, and funding of advanced healthcare technology. I have especially advocated creation and widespread use of massive-testing technology for early detecting, and thereby better managing, communicable diseases.

On the very top of the list of new massive-testing technology I have advocated is: “very low cost, fully at home (and at work) infectious disease antibody detecting test devices, ones capable of nicely supporting widespread massive-testing programs.” Coupled with that testing platform is the strategy of integrating those low-cost testing devices into a “system” that supports a number of features able to ensure the financial feasibility and logistical plausibility of testing up to 100 million workers around the country at a time. Until now, there was no advanced technology to do this. Now there is and the time is ripe.

The key features that would have to be supported in the test are obvious. The key features that would have to be created by the system are less so. Employers cannot take back to work employees who are not certified to be either immune or currently virus free. How will they know that? Only if there is a “system for massive testing.” How might an employer rely on the test results? Only if there is a “system for funding and oversight” by each state, as well as components of the system for test authentication, test-result confirmation, and test-report certification, including protection both of the authenticity of test results and of their chain-of-custody.

SAFE RECOVERY IS A TEAM SPORT

All I seek is your immediate and thoughtful review of the two-safety-precautions plan, which is intended to be integrated with the President's plan, and if you believe it is warranted, your funding support and your political support for YOUR program.

Where we go one, we go all. A safe recovery is a team sport, and the ONLY sport.

Best,

John

For more information, read the full-length Open Letter to U.S. Governors.

ABOUT JOHN NORRIS

The Hon. John Norris is an FDA Former Principal Deputy Commissioner, a Harvard Former Health Policy and Management Faculty Member, a Massachusetts Former Chairman of the Clinical Laboratory Regulation Reform Commission, and Chairman of FDTH Regulatory Affairs Strategies, as well as an inventor-entrepreneur and frequent drug, device, Healthcare-IT, clinical lab, and hospital-system visionary, innovator, advisor, and board member. He can be reached at john.norris.jd.mba@fdthregulatoryaffairsstrategies.com.

John Norris
FDTH Regulatory Affairs Strategies
+1 617-680-3127
email us here

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