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Memo 05.04.2020 10 minutes

It’s Time for Radical Federalism—Starting with FDA and CDC

McInnis_CDC FDA

Leviathan is hazardous to our health.

Covid has rotted the mask away: all Americans can see the putrid incompetence at every level of institutional power. No institution is spared—not public health bureaucracies, not private employers, not media outlets, not hospital administrations. Change must—and will—occur as we analyze their responses.

A knee-jerk American response will be to increase spending for FDA/CDC budgets and state health authorities. This would be to learn exactly the wrong lesson. America’s FDA and CDC have lost their way: they are more concerned with prerogative and power than containing a killer outbreak. Their behavior merits a defenestration by the American public.

FDA is authorized to protect the public good by overseeing the safety of America’s food, drugs, and medical supplies. CDC is empowered to protect public health by controlling and preventing disease. Both agencies have enjoyed the bloated budgets that come from an appalling and unwarranted degree of scope creep.

Even technological devices that may affect long-term health are now under FDA’s purview. Anything that can be labelled a disease by academia, like obesity or gun violence, is now within CDC’s reach. Scope creep makes these agencies easier targets for more interference from industry. As economist Alfred Kahn wrote, when agencies are responsible for industries, they are “under never completely escapable pressure to protect the health of the companies” that they regulate.

Capture is formalized now. Budgets have outpaced funding, leaving FDA dependent on industry user fees to fill the gap. These user fees make FDA dependent on the very manufacturers seeking approval. Forty five percent of FDA’s budget is paid by industry user fees; for human drugs it is 65%.

As a federal agency, FDA must be cognizant of the pharmaceutical sector that a state would not consider if it lacked the presence of a Merck, Roche or Eli Lilly. FDA and CDC both employ advisory committees on topics, drugs, and treatments that are stocked with industry-funded scientists and researchers. Neither agency has the budget allocations to fund nonpartisan blind studies or at the least, create a mechanism for funding research to minimize or eliminate bias on results and advice to the Agencies.

The great centralization that has occurred for over seventy-five years in American politics has built a stiff, lumbering giant that cannot move and has lost sight of its original mission. More of the same will only make a more brittle machine for the next pandemic.

Instead, America must engage in radical federalism.

Decentralized Pandemic Response

America has the infrastructure in place to allow for this. But it will require the Trump administration to dismantle and redirect the powers and the funding for the CDC and FDA down to the states. The block grant method employed by Presidents Nixon and then Reagan to eat away at some of the Great Society programs should be used to route around the sclerotic bureaucrats of the current centralized organs.

When founded over 100 years ago, the FDA would have had access to resources many American states would only dream of deploying. The same applies to the CDC, founded in the Truman era. But this is no longer the case—investments in science at universities across America have sprinkled BSL 4 and BSL 3 facilities across the lower 48.

State governments flush with what would formerly have been federal cash will have the flexibility and freedom to customize what health crises they have and need to address. “One size fits all” does not apply to America. Americans should embrace the nimbleness and flexibility that this will grant states to address problems. Even before Covid-19 showed up, the opioid crisis was a regional affair of varying severity across states.

Bring Subsidiarity Back

As long as the problem can be adequately tackled at a location or by a political unit of a certain size, it need no larger political body to deem it acceptable. How different would the Covid-19 outbreak be had not one individual at University of Washington told the CDC/FDA to go to hell about testing, developed and deployed their own?

The CDC and FDA used a series of embarrassing regulations as the excuse for why actors at flashpoints were delayed in reacting or did not taken action at all.

The testing bottleneck had to be smashed by Vice President Pence rather than a single bureaucrat seeing the light.

One FDA rule barred 3M from selling millions of N95 masks to medical clients because they were labeled construction mask despite being the same mask.

Plans for mask making plants must wait for approval despite the 21st century allowing for electronic file sharing and video conferencing to review locations.

There are many more problems we could list. America’s centralization is now past the point of negative returns. All corporate restructuring veterans know that when a company flattens its hierarchy (centralizes) it will be successful only if the lower functionaries have been empowered to make decisions—if fewer decisions have to work back to the smaller, senior cluster. The federal government flattened all middlemen and left state and local authorities gelded.

A History of Failure

The FDA’s and CDC’s fumbled Covid-19 outbreak responses are just their latest mistakes.

The CDC waited years to allow research on the 2014 enterovirus outbreak (causing partial paralysis in American children), which makes little sense unless there were concerns that the source for enterovirus would be linked to Central America.

The CDC mishandled Ebola quarantining protocols, failing to learn lessons that should have been applied to Covid-19.

The FDA has helped foster a nation of unrivaled obesity thanks to its dietary guidelines and recommendations.

Vioxx killed thousands of Americans and was pulled off the market by the FDA despite being FDA approved just five years earlier.

The last success the FDA can point to is the historic denial of thalidomide by the FDA sixty years ago. This was the success story that validated the FDA’s very mission, saving babies from deformities and death compared to the poor children of Europe.

Have you ever heard of Bendectin? Like thalidomide, Bendectin was a morning sickness medication that hit the market in the 1950s. The FDA approved it. Bendectin also caused fetal malformations, brain and organ damage, and musculoskeletal disorders. Lawsuits and bad press caught up with it, and twenty seven years after hitting the market, Bendectin was pulled from distribution in 1983.

Personnel and the Ideology of Failure

America will not get the satisfaction of a medieval defenestration of the bureaucrats, but a dismantling of the FDA and CDC is possible. Americans understand the incompetence of government workers, hence the widespread jokes at their expense. But they need to understand that the job trees at these agencies are patronage rewards from top to bottom. Political loyalty is most important; the second filter is the repetition of progressive ideological purity, of which Cal Berkeley’s diversity statements are just the most extreme example.

Even our Covid-19 response has been affected. Dr. Susan Gerber is the team lead for respiratory viruses at the CDC. Dr. Gerber was an author of a paper on controlling the outbreak of influence in a chronic care facility. This paper and study did not offer a CDC recommendation to prevent New York from sending convalescing Covid patients to New York nursing homes, worsening the outbreak and consigning the most vulnerable to death. Dr. Gerber was involved in a study of transmission of MERS-coronavirus in health care settings. This experience did not lead to nationwide protocols for handling new Covid patients. She was installed in 2012 under President Obama. Her experience? She was board certified in pediatrics and worked for thirteen years in Cook County’s department of public health. This approach to hiring is similar in every government bureaucracy.

Consider: the initial response of many of our bureaucrats to the Covid-19 outbreak was to update the website to discuss the stigma of Covid-19 carriers or talk about hate and racism.

But recent moves by the Trump administration with regard to the Bureau of Land Management and the Department of Agriculture point to the possibility that we can break up these centralized institutions by embedding them within the fifty states. Everyone reading this knows that relocation packages are never accepted by an entire department—in many instances, there are single digit acceptance rates. Breaking up centralized departments and agencies into regionalized offices is a convenient way to sandpaper off partisan ideologues.

This is not the only piece to the solution as the American right must come to grips with all bureaucracies being beholden to the progressive ideology of the day. Nominally Right-leaning states must flex their power and prevent ideological capture when power is granted to them. Even when science changes and research refutes priors, the FDA/CDC ship does not turn. The FDA, to take one recent example, waged a multiyear battle with the makers of KIND bars. KIND wanted to have “healthy” on the label. The FDA denied the request, claiming the bars are not healthy due to their saturated fat content. The battle raged on, and despite all the positives of KIND bars, the FDA would not back down. Eventually, the FDA allowed KIND to put “healthy” on their packaging. But the agency is still trapped in the mindset that eating fat will make you fat despite evidence pointing in exactly the opposite direction.

The way to break this ideological grip on institutions and encourage professionalism over patronage is to allow diversity of opinion within the fifty future FDAs/CDCs. Republican governors should seek to staff both the public entities that would receive new funding with heterodox thinkers. Because these governors will likely employ private firms on a contract basis for some of these functions, they should seek not just the lowest bidder but teams that will think outside the progressive bubble. They should also bring back civil service exams for these positions. Fire fighters and police officers have to take exams, therefore all other health security positions should as well.

This idea starts with just the FDA and CDC but can grow to apply elsewhere. These two institutions were created when pooling resources for a central command made sense. They also made more sense for the America that spawned them, not the America of today. What America is today is an empire with great variation found within its borders. Visuals of long lines outside Costco at the whiff of a viral outbreak that may kill 2% of those infected hint at a population that sees its nation as a paper tiger. Even those who vocalize a desire for collapse reveal the feeling of helplessness and desire for change to the structure of a society that they feel does not care about them any longer. If America sees this outbreak, shovels money at existing structures and moves on, it will only fuel the anger and resentment of its population. If America chooses to use this opportunity to disseminate the FDA/CDC powers to the fifty states, it may find more powers and procedures to devolve to states to make the American nation more effective at handling crises and keep the American nation together longer.

That is the hardest thing to overcome but must be overcome for those who want to see America survive and thrive. The credentialed elite in the Acela corridor is going to have to give up on dominating the provinces in every realm whether wealth, status or mental. The Middle America rebellion against the elite that found an avatar in Donald Trump needs to translate the energy and the reality that its mental framework is right into results and institutional power. It must move from leave me alone to ruling. One path leads to more centralization, an elite that fails at each new challenge until a final blow. The other leads to a reorganization and restructuring of power and capabilities that will allow America to react fast, be nimble and customize the response to any challenge that comes its way.

The American Mind presents a range of perspectives. Views are writers’ own and do not necessarily represent those of The Claremont Institute.

The American Mind is a publication of the Claremont Institute, a non-profit 501(c)(3) organization, dedicated to restoring the principles of the American Founding to their rightful, preeminent authority in our national life. Interested in supporting our work? Gifts to the Claremont Institute are tax-deductible.

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