Health care reform

Dump the FDA for a Healthier America

The agency has hampered widespread COVID-19 testing and the production of both protective gear and hand sanitizer.

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Even before federal red tape delayed development and deployment of COVID-19 testing and hampered the acquisition of protective gear for medical professionals, the U.S. Food and Drug Administration (FDA) had a reputation as an obstructionist bureaucracy that emphasizes caution over innovation. That caution comes with a price tag in human lives that might have been saved by faster access to new drugs and devices.

Although it's usually been largely invisible, that regulatory price is now on public display. As a result, this may be our best opportunity to abolish, or at least reform, this deadly government agency.

Helen Chu, a Seattle-based infectious disease expert, became a national hero by defying federal rules to test for the presence of COVID-19 in the local population. Chu's February act of defiance gave us confirmation that the coronavirus pandemic was spreading in the United States even as the federal government stood in the way of widespread testing for the disease's presence.

"Stephen Hahn, 60, the commissioner of the Food and Drug Administration, enforced regulations that paradoxically made it tougher for hospitals, private clinics and companies to deploy diagnostic tests in an emergency," reported The New York Times.

That means that developers of COVID-19 tests encountered absurd regulatory barriers that slowed efforts to get them to the public. For example, after applying for an emergency use authorization for the test he developed, University of Washington epidemiologist Alex Greninger discovered that he was required to mail physical copies of the application to the FDA. That was only the beginning of a regulatory ordeal that delayed vital testing until COVID-19 was well-established in the state.

While the feds kneecapped academic, commercial, and hospital efforts to detect COVID-19, officials were hard at work to keep testing a federal monopoly. That effort proved disastrous when the test developed by the Centers for Disease Control and Prevention (CDC) proved to be flawed and essentially unusable. But even after the CDC testing fiasco, the FDA stood in the way of independent testing.

"Hospital lab directors say the FDA validation process is onerous and is wasting precious time when they could be testing in their local communities," ProPublica reported at the end of February.

The FDA played a similarly obstructionist role that contributed to the shortage of protective N95 masks. While high demand inevitably resulted from fear of the spreading virus, red tape required medical facilities to use only approved masks while barring the purchase of essentially identical products made for industrial use, choking off access to millions of perfectly usable masks.

Approval requirements and overlapping rules from multiple agencies are so confusing that even the FDA concedes that "regulation of N95s may create confusion among stakeholders."

Only in mid-March did the FDA ease the way for hospitals to purchase industrial N95 masks. Unfortunately, the preexisting rules limited the market to those few companies willing to run the regulatory gauntlet; it takes time for new sources to get up and running.

And with the FDA hampering widespread testing and the production of protective gear, would it surprise you to know that it also bears some responsibility for the short supply of hand sanitizer?

Distilleries, which have plenty of alcohol on hand, want to venture into the hot market for alcohol-based sanitizer. But even the FDA's pandemic-era loosened rules require the addition of a denaturant to the alcohol that renders it—and anything made with that alcohol—undrinkable lest somebody decide to use it as a cocktail substitute.

"If we introduce a denaturant into our lines, it renders them useless for future alcohol production barring extreme cleaning measures, because we cannot have any remnant of the denaturant in our lines, and then sell a consumable product," warns Matt Dogali, the President and CEO of the American Distilled Spirits Alliance. Not surprisingly, distillers hesitate to contaminate their production lines.

That's the crisis-era FDA for you, poisoning us for our own good.

But the FDA threatened Americans' health long before COVID-19 appeared on the scene. If you've ever wondered why it takes so long for promising drugs to come to market, or about the price tags they bear once they do, you can thank food and drug bureaucrats for the roles they play.

The full cost of developing a single new drug and seeing it through to approval by the FDA is roughly $2.6 billion dollars in 2013 dollars, according to a 2014 study by the Tufts Center for the Study of Drug Development that was published in the Journal of Health Economics.

That's not the end of it, either. The Tufts researchers also found that drugs are having a tougher time than in the past in making it through the FDA approval process. While they couldn't be sure why, they speculated that "regulators have become more risk-averse over time."

Approval of medical devices is cheaperin the tens of millions of dollars rather than billionsbut beset by the same bureaucratic delays that plague pharmaceutical approval.

Medical device companies "viewed current U.S. regulatory processes for making products available to patients (the premarket process) as unpredictable and characterized by disruptions and delays," according to a 2010 survey for the Advanced Medical Technology Association.

Respondents complained that key FDA personnel vanished and were replaced during the review process. Even when faces stayed the same, regulators often failed to show up for key meetings, dragging out the review. As a result, "devices were available to U.S. citizens an average of two full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country."

Much of the problem is that bureaucrats, as the Tufts researchers suggest, are risk averse. They're afraid of being pilloried if a drug or device is approved and people suffer side effects, while they'll never be held accountable for illnesses or deaths that result from a product being delayed or buried entirely. But those lost lives represent very real costs.

"Drug lag costs lives because people suffer and die from disease that might be treatable, if only there were more investment in finding a cure," argues Jessica Flanigan, an associate professor at the University of Richmond, in her book, Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate. "Premarket testing conditions also cost lives because patients with conditions that could be treated or cured by unapproved drugs suffer and die while they are waiting for approval," she adds.

If the FDA and other regulatory agencies are to have any role, Flanigan reasons, it should be restricted to informational certification of drugs as being safe, while allowing patients and physicians to abide by or disregard such advisory certification as they please.

There's no particular reason that certification would even require the continued existence of the FDAit could be handled by private organizations, as advocated by Noel D. Campbell in a 1997 Cato Institute paper. Such certification "provides valuable information to consumers and leaves manufacturers and consumers free to trade with one another—a basic right in a free society," Campbell wrote.

A very limited example of letting people make their own decisions comes in the form of the 2018 "right to try" law that gives terminal patients who have exhausted all other options access to investigational drugs. Giving everybody more freedom to make such choices could alleviate a lot of suffering that results from regulatory roadblocks erected by risk-averse bureaucrats.

Who knows, maybe we could even let medical professionals design tests and purchase protective equipment without awaiting federal approval. When you let people make their own decisions, anything is possible.

NEXT: There's Light—and Growth—at the Other End of the Coronavirus Tunnel

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  2. Even before federal red tape delayed development and deployment of COVID-19 testing and hampered the acquisition of protective gear for medical professionals, the U.S. Food and Drug Administration (FDA) had a reputation as an obstructionist bureaucracy that emphasizes caution over innovation.

    This statement has not been evaluated by the Food and Drug Administration.

    1. The FDA is progressivism in action. The “Rule of the Experts”.

    2. This situation SHOULD point out the irony of leftist views on regulation. Most of them see it as a binary choice between zero regulation and ‘create every regulation I can think of to protect everyone from any possible circumstance’ and “deregulation is evil like Satan”. And let’s not forget their leftist rule that government should maintain a monopoly on anything having to do with health… cuz evil corporations.

      NOW when their lives are are at risk, “What’s taking so long? Why aren’t corporations pulling out all the stops? Give us the test kits… give us the damn test kits! Whadayamean regulations? Fuck regulations… we need test kits!.”

      This is the perfect lesson in the idea that government’s best role is as a facilitator and to coordinate activities between the States, not as the swamp of government regulators whose primary job is creating more swamp to be in charge of. I’m guessing that most won’t learn this lesson. If this were to end tomorrow, leftists would be back with “deregulating is evil” and “evil corporations making a profit off illness” bullshit.

    3. Subjecting government to critical analysis is an important task of economics, just as is subjecting the market system to critical analysis. One recurring — and fully warranted — criticism of government agencies is that they are often subject to being captured by the people they are supposed to be monitoring and controlling, so that instead of monitoring and controlling them, they become their agents and protectors. This phenomenon of regulatory capture has often been depicted as inevitable. However this claim is belied by the fact that a few years ago the financial sector put up determined resistance against the appointment as head of the federal agency newly created to defend consumers’ rights of an individual well known for her advocacy of consumers and criticism of bankers. This episode clearly proved that regulatory capture is not an inevitable process, but instead one whose success depends on exerting political pressure.
      It is a well known fact that the FDA was long ago captured by the drug companies. Accordingly the policies of that agency are by and large designed to favor the pharmaceutical industry and not the American public.
      Consequently critique of the FDA and other government agencies should not concentrate on a supposed inefficiency of government to the exclusion of all other criteria that are equally important, namely in this case, regulatory capture. However the flea-market crowd, which is amply represented on this website, obstinately ignores undisputed phenomena like regulatory capture when it comes to criticizing government. For them, government as such is the enemy. This is an instance of ideology prevailing over scientific analysis.

  3. Hear hear!

  4. But it clearly states in the US Constitution that the federal government is to be charge of each and every aspect of the citizens life, right down to who pays for killing babies.

  5. Wuhanvirus hysteria.

    1. In other news (warning: this is not The Onion). Venezuelan Warship fires into German cruise vessel, sinks. https://www.jpost.com/international/venezuelan-warship-shoots-rams-into-german-cruise-vessel-before-sinking-623422

      1. Hmm…does this mean that the Venezuelan navy has adopted a policy of sinking one of its ships from time to time ‘to encourage the others’?

  6. Having worked in the R&D department of a medical device manufacturer, I have first hand experience with those frivolous, duplicative, wasteful, and just plain ridiculous government regulations, and their many faceted interpretations by every halfwit reviewer in the building. The reason a $10.00 pair of scissors costs 100.00 is because the FDA requires twenty metric tons of paperwork to make those scissors. Good luck cutting through the red tape there. You need a team of lumberjacks with chainsaws to even make a dent in it.

    1. The reason a $10.00 pair of scissors costs 100.00 is because the FDA requires twenty metric tons of paperwork to make those scissors.

      Exactly — If anyone wants to know why they cannot afford healthcare; there it is!!!!! I read an article that showed on a ledger it takes $1M just to get a new drug on the market; all thanks to FDA/CDC.

      1. …it takes $1M just to get a new drug on the market; all thanks to FDA/CDC.

        It’s closer to a billion. Or more. Maybe a million will buy you the address you’re supposed to send all the paperwork to.

    2. I worked for a company that made machines to screen pap smear slides.

      If we flipped one bit in algorithmic code, we needed a full clinical trial.
      But we could fiddle with “system integrity” parameters to our hearts’ content.

      We did have that clinical trial, and the FDA violated their own bogus statistical standards with an even more bogus statistical test to reject the trial.

      So women got worse care across the country for years.

      The healthcare industry is 90% carving up patients pound of flesh among the medical mafia. If there is time leftover, they’ll think about healing you.

  7. This article contains ideas known by the State of California to cause dangerous notions of individual freedom and responsibility, not to mention cancer and hurt feelings.

  8. doncha know, its only because Trump is POTUS.

    Coronavirus would never have taken hold of American shores under President Hilary Clinton’s FDA!

    1. Well, the hysteria is because of the desire to get rid of Trump.

      1. Yes, no question that there would not be this hysteria if Dirty Hillary was the president.

        The media and democrats (sorry to be redundant) are sure going to a lot of trouble to get rid of Trump. But it’s back-firing.

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  9. 15 years ago I waited FDA approval of a new drug for treatment of a condition which was extremely painful. The FDA stalled a year (the legal maximum at the time) then requested more data from the drug company. This was a typical FDA tactic in those years, and the total time for approval took just under three years. If one considers the number of people who die waiting for drug approval, the FDA probably kills more people than it saves.

    Check the following link– ‘Nestoring’ seems an appropriate metaphor for the way the FDA operates.
    https://sevenfigurepublishing.com/2014/04/22/the-cost-of-not-acting/

  10. Plus – the whole “off-label” treatment bullshit. Reports from China and other places were available 2 months ago that anti-malarials were working against the virus. Instead of ordering a billion doses from pharma companies, the FDA dragged their feet. Finally a couple of days ago they approved “Emergency Use” of the drugs. They are worse than useless.

    1. This.

      Federal Death Administration.

  11. I’ve been thinking for several years that we not only need to eliminate the FDA and bring in a new regulatory agency (better a private sector certification organization similar to Underwriters Laboratories), but anyone who worked at the old FDA in a position higher than janitor should be barred from employment at the new agency. As the article highlights, the main problem at the FDA is the organizational culture, in which their employees are currently marinating. It is rotten to the core.

    1. EXACTLY – Privatized standard organization has proven beyond any doubt to be FAR, FAR, FAR better at high-standards. ISO, EEC, EEEE, UL, etc.. etc.. etc…

  12. Real shocker. Imagine you being an FDA agent that helped slow down people wanting to help others during a pandemic. Nice.

    It’s amazing how everyone else bends a little and does their part but bureaucracies like the FDA refuses to do so. In order for ‘we must all do our part’ to work not a single entity must break rank.

    The FDA – a critical obstacle to helping people – broke rank.

    They must be held to account and Hahn should resign.

  13. “obstructionist bureaucracy” is redundant term. All bureaucracies are obstructionist. That is an unavoidable product of coercive govt. Why attack the leaves/branches of the poison tree only to see them grow back? Attack the root! Stop supporting, in word/deed (voting) the political concept of authoritarianism.
    Be a consistent libertarian, e.g., a voluntarist. The new political paradigm of non-violent governance, not tried anywhere yet, is the fix for political corruption. It’s either-or. There is no third way.

    1. One definition of a bureaucracy is an organization where following the rules is more important than achieving the objectives the rules were originally instituted to further. So yes, to all practical purposes, “obstructionist bureaucracy” is redundant.

  14. The FDA is unconstitutional!!! Does anything else really need to be said about it? The more the USA ignores who it is (defined in the U.S. Constitution; the worse off it gets). People keep debating what “brand” of communism we should inherit – those people need to MOVE back to their slop-hole from which they ran-away from else be viewed as the treasonous traders they are.

    What makes the USA any different from any other dictated crap-hole of a country? The U.S. Constitution!

    1. The American Colonists paid total taxes of 1-2% of GNP. The USA people through 1913 paid total taxes of 4-8% of GNP. The generations who produced those small governments were what made us the productive business people we are.

      The Constitution has never been followed closely, but in those years those generations at least didn’t massively defy it (except to long keep depriving persons of liberty). All it takes to limit government way better is to have at least one major party whose people in government each use their constitutional powers to limit others in government. A plan to get there and stay there is in my book The Constitution Needs a Good Party: Good Government Comes from Good Boundaries.

  15. Both the FDA and the CDC are corrupt beyond repair. They are arms of the even more corrupt Big Pharma mafia. Throw in WHO, a purely Marxist run organization, and you have the prescription for an over-vaccinated zombie filled world. The entire medical system needs to be blown up because there is no one to fix it, and Congress is the last gang of cutthroats I would trust. We need term limits and the expulsion of lobbyists. Good luck with that.

  16. We need an FDA. We just don’t need the FDA we’ve got. I forsee a massive bloodletting at this FDA when the crisis is over.

    1. Dream on. Federal civil service employees can’t be fired or even disciplined except at great cost and effort. When it does happen, the decision is as likely as not to be modified or reversed by the Merit Standards Protection Board. Federal workers know that they will not be disciplined for doing nothing, but could be disciplined for doing something that turns out to be wrong. It’s an easy choice.

      1. Unions insure that incompetency is compensated.

    2. “We need an FDA” — Oh horsesh*t..
      You just *think* that because that’s all you know (GOV worship).
      The entire www doesn’t need a World Wide Web Administration to function properly and filter out the bad players so what in the world makes you think an FDA is needed to filter produce. WHERE-EVER there is a *need* the people will pay for it – and in return people will seek to fulfill that *need*. Law is ONLY there for individual justice and national defense against foreign attack.

    3. No, we don’t need an FDA, at least in the sense of a federal agency with the impossible mission of determining the ‘safety and effectiveness’ of drugs and medical devices. Government licensing–as opposed to private sector certification–of chemical compounds to use in treating certain diseases is no more necessary or desirable than government licensing of individuals to practice certain occupations.
      As for your ‘bloodletting’, that’s a laugh. The FDA will do what any regulatory agency does when it fucks up: it will whine that that’s what you have to expect when it doesn’t have enough money, enough people, and enough power. And the members of the House ‘oversight’ committee will nod as one and double the budget and headcount and authorize it to bungle on double the scale of before.

  17. See “Our Enemy, the State”, by Albert Jay Nock. There, he paints a picture of what we have become.

    1. Thanks for this; this is an excellent read!

  18. Wearing a mask is nothing bad, it is a practical action to protect your health
    https://gamebug.net/play/happy-wheels

  19. Follow the money for the reasons of how the FDA was put together.

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  21. Now this is the kind of article that fits Reason’s pro-liberty values!

    Very good!

    1. “Dump the FDA for a Healthier America”

      Refers to book: “Pharmaceutical Freedom: Why Patients Have a Right to Self-Medicate. ”

      I’ve been calling for this article for years at Reason. Finally, an article for healthcare reform that isn’t just for more *corporate* freedom, but actual personal freedom from government regulators *and* the rent-seeking medical mafia. Your body, your choice.

  22. Can someone explain why the denaturant has to go through the distilleries plumbing? What can’t it be added to barrels of ethanol?

    1. The purpose of denaturant is to blind or kill any who do not pay the Excise tax on ethanol. The Pure food law of 1906 took coercive effect 1907 and immediately redefined whiskey, many drugs and a host of items such as sardines in the midst of state-level prohibitionism shutting down ice houses. What better time to pass the 1908 law requiring the government to try to poison American citizens? No accountability, I know of no indictments for these acts of premeditated eugenic genocide for Jesus. But failure to poison, or removing the poison were felonies, and many were fined and jailed for that.

  23. What Tucille suggests was in the original LP platform–which did not call for uninspected entry of plague victims or infected cattle both Reason and the Libertarian Pratfall Committee have screeched for these past two years. This sort of sabotage gets voters wager to lynch the LP, not hand us spoiler votes with which to pressure the looter parties to abolish sinecures and repeal bad laws. The comments section is squatted on by simian mystical republicans who live to bully girls by pointing firearms at physicians–and nothing else.

  24. US Government bureaucracy’s, all of them need a deep house cleaning. AKA Draining the Swamp. And deep starts at the top…

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