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Coming Soon: A Red-State Vision Of Healthcare Regulation

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James P. Pinkerton Fox News Contributor
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On just about every policy issue, this country is too big for one size fits all. A case in point is the response to COVID-19; these past two years, we’ve seen polarization, red vs. blue, on controversies including lockdowns, masks and vaccines.

This polarization is concerning to many, and yet the resulting differentiation is good. We can ask: What would have happened these past two years if a government had tried to make, say, Florida and Massachusetts abide by the exact same COVID rules? Such attempted sameness would have been a disaster of anger and rancor.

Thus we are reminded: freedom is a safety valve. That is, freedom, coupled with compartmentalization — also known as federalism — is a way of managing boiling pressure: you blow off steam your way, and I’ll blow off steam my way. Also, steam-release includes “voting with your feet”: Revealingly, according to the Census Bureau, Florida enjoyed the greatest domestic migration gain in 2020-21 (Texas was second, and Arizona was third). (RELATED: California Population Drops For First Time Following COVID-19 Pandemic, Ongoing Exodus)

Now a new arena of red-blue dichotomy is opening up — or should we say, opening up even wider. The flashpoint: monoclonal antibodies (MAB), a treatment for COVID-19. In 2020, after he was stricken with virus, former President Donald Trump received MAB, and within a few days, he was back at it. Since then, more favorable evidence for MAB has poured forth; in September, Health Affairs, a mainstream policy and research journal, declared it “a potentially life-saving therapy,” urging an all-out effort to expand production and undertake additional research and development.

The governor of Florida, Ron DeSantis, has been all over MAB; state health authorities have trumpeted dozens of MAB treatment stations. In the meantime, testimonials have piled up: Here, for instance, are the words of one Frances Novak: “I was fortunate to get a Regeneron treatment here in Florida January 6. I had been very ill with Covid for 3 days before the treatment. After the Regeneron, I got better immediately. Thank you Governor DeSantis for fighting for Floridians to get Covid treatments.”

But then came the federal hammer. On Jan. 24, the Food and Drug Administration (FDA) imposed sharp limits on the use of MAB. The FDA’s rationale was that it was not effective against the Omicron strain of coronavirus. Given that Omicron was only detected in late November, it seems strange that the agency would have made this rush to judgment.

DeSantis was quick to hit back: “Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law.” He continued, “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives.” (RELATED: DeSantis Hits Biden For Cutting Supply Of Antibody Treatment To Southern States For ‘Equity’ Purposes)

Writing in The Wall Street Journal on Feb. 7, Dr. Joel Zinberg, an associate clinical professor at the Icahn Mt. Sinai School of Medicine, agreed, “The Biden administration seems to think it knows better than physicians how to practice medicine.” Zinberg added of the FDA, “Its haphazard micromanagement … has created supply shortages, spread confusion, probably harmed patients, and undermined future treatment.”

So we can return to the point about one size not fitting all. And if there’s ever an agency that proves that dictum, it’s the FDA, founded in 1906. These days, just about every expert agrees on the importance of personalized medicine, defined by the National Institutes of Health as “an emerging practice of medicine that uses an individual’s genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease.”

More broadly, personalized medicine speaks to the desire — and the technology — to empower healthcare providers to address patients as individuals, each with unique traits, risks and preferences. And since there are more than 332 million Americans, we can see why the FDA is hard-pressed to keep up; it simply doesn’t have the capacity to nuance itself to all the patients’ possibilities. The FDA is not you, or your doctor, it’s a hidebound bureaucracy that can do no better than seek out the lowest common denominator of public safety — and do that only ver-r-r-y slowly.

In fact, in situations of genuine health emergency, the FDA concedes that it is inadequate to the challenge. Thus in 2020-21 the agency waived its normal approval process for COVID-19 vaccines. Why? Because it was a crisis; people were dying, and so there was no time for bureaucrats.

Today, COVID-19 is still a crisis; just in January 2022, Americans died from the virus at the rate of more than 1,900 a day. In other words, in 2022, there’s just as much reason as ever for the FDA to get out of the way of life-saving COVID-19 treatments.

Yet bureaucracies don’t like to cede turf. So for the FDA, it’s paper-shuffling-as-usual; favoring and disfavoring life-saving treatments according to its own black-box whims. (RELATED: EXCLUSIVE: House Republicans Demand FDA Withdraw Race-Based Criteria For Monoclonal Antibodies)

And yes, let’s say it out loud: The FDA’s stance on MAB is heavily colored by the standard-issue blue-liberal attitude towards Trump, DeSantis and red states. It’s through that snobby prism that FDA bureaucrats see MAB, as well as, of course, such even “Trumpier” treatments as ivermectin and hydroxychloroquine. For woke “blue-ocrats,” it’s easy to ignore, for example, all this evidence about the effectiveness of alternative treatments. But for the rest of us, there’s no reason to trust politicized Biden-appointee “science.”

Here’s a prediction: In this age of red-state governors defying the president (and truck drivers and others, too), there’s going to be a test case on MAB soon. Somewhere in the red territories, someone is going to start selling MAB, full auto and perhaps even start making it — after all, as the FDA has made MAB scarce, the price will be higher.

So what then what will the FDA do? If people are flocking to a MAB site, will the FDA convince, say, the FBI to swoop in and shut it down? Yet as we think about such a possible raid, will a red-state governor simply stand by and watch it happen? Will the red governor think that pleasing the Biden administration is more important than helping desperate patients? And will Republicans in Congress sit idly by?

To get a sense of the populist fury that’s already being unleashed on this cluster of concerns, we might consider this Feb. 8 tweet from Donald Trump, Jr.: “So the Biden Administration thinks it’s a great idea to give out crackpipes but definitely not Ivermectin or Hydroxychloroquine. Let that sink in!”

This author would bet that in a MAB standoff, the Biden administration would stand down. And if so, then we’d be on our way to a new era in healthcare regulation; that is, the familiar blue-federal model will have a new red-state rival.

Ideally, a new paradigm of red-state oversight would emerge. It needn’t be a temple of bureaucrats such as the current FDA, which employs 9,000 people, spread over 130 acres, at its Maryland headquarters. Instead, a red FDA could be virtualized; it could be a digital clearinghouse for all available information about a treatment. All the studies and data points could be algorithmed and metadata-ed into a user-friendly dashboard.

Then patients and their doctors could make an informed choice, exercising their right to try. And of course, blue-staters could study the information, too, and they’d have a choice: Stick with the old system, or experiment with the new system — although to be legal, they might first have to move to a red state.

To be sure, it would be a messy process. But freedom is messy, because it comes in more than one size.

James P. Pinkerton, a former White House domestic policy aide to Presidents Ronald Reagan and George H. W. Bush, has been a Fox News contributor since 1996.


The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller News Foundation.

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