FDA: Rewarding Itself for Failure by Grabbing More Power

The Food and Drug Administration has a rather dismal track record.

• Imposing a lengthy and expensive drug-approval process, leading to thousands of premature deaths.
• A bungled and incompetent response to the Covid pandemic.
• Its regulatory assault against vaping, this increasing the risk of smoking-related deaths.
• Exacerbating the shortage of baby formula.
• Absurd and silly examples of regulatory overreach.
• Needless cruelty to people with terminal diseases.

In other words, the FDA does a bad job and thus is a typical Washington bureaucracy.

It’s also a typical bureaucracy in that it wants more power and authority.

Here are some excerpts from a column by Joel Zinberg for National Review.

…the FDA’s proposed rule…explicitly asserts its long-claimed authority to regulate laboratory-developed tests (LDTs) as medical devices. …LDTs are performed billions of times a year in approximately 12,000 CLIA certified high-complexity laboratories… Despite the FDA’s claims to the contrary, there is little evidence that LDTs are less reliable or accurate than FDA-approved tests. And awaiting the FDA’s review and clearance of new tests can delay critical testing with disastrous results. Early in the Covid-19 pandemic, the FDA ceased its usual exercise of enforcement discretion… Unfortunately, the only EUA the FDA initially granted was for the Centers for Disease Control and Prevention’s test. Despite evidence that the CDC test was unreliable, the FDA persisted in requiring test EUAs that it seemed unwilling to grant. Testing was essentially unavailable during February 2020 as Covid-19 spread around the country.

Zinberg also explains that the FDA is ignoring the law as part of its campaign to impose billions of dollars of costs the industry.

It is doubtful that the FDA has statutory authority to regulate LDTs. The 1976 Medical Device Amendments to the FDCA do not mention laboratories, laboratory tests, or laboratory-testing services. …The FDA acknowledges that its rule will impose significant compliance costs on laboratories that offer LDTs — $35.5 billion over the multi-year phase-in and additional recurring costs of $4.2 billion — leading some laboratories to exit the market or discontinue certain LDTs they offer. Ninety percent of the laboratories offering LDTs are small businesses.

By the way, take a wild guess who will bear this multi-billion-dollar cost.

If you answer consumers, congratulations for being brighter than 98 percent of the people in Washington (admittedly that doesn’t say much).

Professor Alex Tabarrok of George Mason University was very blunt about the FDA’s proposal in a post for Marginal Revolution.

I have been warning about the FDA’s power grab over lab developed tests. Lab developed tests have never been FDA regulated except briefly during the pandemic emergency when such regulation led to catastrophic consequences. Catastrophic consequences that had been predicted in advanced by Paul Clement and Lawrence Tribe. Despite this, for reasons I do not understand, the FDA plan is marching forward.

Actually, based on this video, I bet Professor Tabarrok does understand why FDA bureaucrats are marching forward.

But he is expressing understandable frustration that they may get away with their bureaucratic power grab.

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An Epiphany for Alexandria Ocasio-Cortez?

I’ve complained about excessive bureaucracy at the Food and Drug Administration.

And this is not just run-of-the-mill grousing about red tape. The FDA actually is responsible for needless deaths because of pandemic incompetence, anti-vaping mentality, and delayed approval for life-saving drugs.

Interestingly, I may now have an unexpected ally in the battle against FDA red tape. Congresswoman Alexandria Ocasio-Cortez, who usually has very statist inclinations, recently released a video condemning the bureaucracy for preventing Americans from having access to better-quality sunscreen.

US sunscreens are far behind the rest of the world and our regulations aren’t necessarily making our sunscreens better or safer — but it doesn’t have to be this way! pic.twitter.com/vaZXpZ2a7S

— Rep. Alexandria Ocasio-Cortez (@RepAOC) August 11, 2023

Wow, she acknowledges that that bureaucracy and red tape can lead to bad results. What an epiphany!

Though I don’t want to go overboard with praise. For instance, it’s not clear if she even wants to strip the FDA of its power to regulate sunscreen.

But perhaps this is the beginning of a long journey to libertarianism.

In which case, her future videos will expressly call for deregulation. And she’ll point out that a policy of “mutual recognition” would allow Americans to directly buy Korean sunscreen (the same approach could have solved the baby formula shortage).

P.S. I’ll close by noting that the FDA also does other bone-headed things. I’ve previously written about the bureaucracy’s war against unpasteurized milk (including military-style raids on dairies!). It also has dragged its feet on liberalizing birth control. Speaking of which, FDA red tape is responsible for the fact that Americans have a much more limited selection of condoms than Europeans.

P.P.S. If you think AOC will remain a leftist, you can click here, here, here, and here to laugh at her statism.

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Long-Run Policy Lessons from the Coronavirus Pandemic, Part II

In mid-2021, I wrote about long-run policy lessons from the coronavirus pandemic.

That column focused on insights from my five-part series (see here, here, here, here, and here) about the failure of big government.

More specifically, the CDC and FDA did a terrible job domestically and the WHO did a terrible job internationally.

By contrast, millions of lives were saved by the private sector.

But we also learned fiscal policy lessons in addition to public health lessons.

The most depressing fiscal lesson is that politicians love having any excuse to spend more money.

Though that’s hardly a surprise.

Now that we are in early-2023, are there more lessons to be learned? The answer is yes.

A new study by Professors Alex Tabarrok and Robert Tucker Omberg, published by the Oxford Review of Economic Policy, finds no relationship between supposed pandemic preparedness and health outcomes.

How effective were investments in pandemic preparation? We use a comprehensive and detailed measure of pandemic preparedness, the Global Health Security (GHS) Index produced by the Johns Hopkins Center for Health Security (JHU), to measure which investments in pandemic preparedness reduced infections, deaths, excess deaths, or otherwise ameliorated or shortened the pandemic. We also look at whether values or attitudinal factors such as individualism, willingness to sacrifice, or trust in government—which might be considered a form of cultural pandemic preparedness—influenced the course of the pandemic. Our primary finding is that almost no form of pandemic preparedness helped to ameliorate or shorten the pandemic. Compared to other countries, the United States did not perform poorly because of cultural values such as individualism, collectivism, selfishness, or lack of trust. General state capacity, as opposed to specific pandemic investments, is one of the few factors which appears to improve pandemic performance.

The study is not free to access, but Professor Tabarrok cited it at Marginal Revolution and shared this chart comparing death rates in the (allegedly) best prepared nation and the least prepared nation.

The Omberg-Tabarrok study shows us that pre-pandemic government policies were ineffective.

What about government policies once the pandemic hit?

In a column for the Washington Times, Richard Rahn points out that heavy-handed government intervention also was ineffective.

Sweden had the lowest aggregate excess mortality percentages (2.79)… Sweden was unique in that it had the fewest “lockdown” requirements, while countries like the U.S., with substantial lockdowns, had much higher excess deaths. We also know that within the U.S., states with very onerous lockdown requirements, like New York, have total age-adjusted higher death rates than states like Florida with few lockdown requirements. The big mistake the CDC people (Dr. Anthony Fauci, Dr. Francis Collins, etc.) made was to single-mindedly focus on potential deaths directly from COVID-19 while largely ignoring the potential deaths indirectly induced by the lockdowns. …Other studies support the evidence of health harm to people who have not yet died but are likely to have their lives shortened by the indirect effects of the lockdowns. …If the above-described mistakes had not been made, it is no overstatement to say that hundreds of thousands of lives and trillions of dollars could have been saved.

The information about Sweden is worth noting.

But the biggest lesson from Richard’s column is that politicians and bureaucrats failed to consider direct and indirect effects (a problem that is sadly common with government), so their cost-benefit analysis (to the extent they did any) was very flawed.

And we also need to learn that it is depressingly easy for governments to curtail liberty.

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Deregulate Birth Control

There are all sorts of reasons to dislike the Food & Drug Administration.

Based on the number of lives lost, the bureaucracy’s foot-dragging on drug approval would be at the top of the list.

Though the FDA’s inefficiencies also resulted in many needless deaths during the pandemic.

And let’s not overlook the other areas where the FDA has a pernicious impact.

But I’m a big believer in redemption. So I’m very hopeful that the bureaucrats will soon do something smart and allow women to purchase birth control pills without first getting a prescription.

One of the reasons I’m hopeful is that some of our friends on the left have sensible views on this issue.

The Washington Post, for instance, recently editorialized in favor of at least partial deregulation.

Paris-based HRA Pharma announced last week that it has applied to the FDA for approval to switch Opill…to over-the-counter use. If approved, it would be the first time Americans would have access to oral contraceptives without the need to obtain a prescription from a health professional. Another pill manufacturer, Cadence Health, has been discussing with the FDA switching its progesterone-estrogen combination to over-the-counter sales in hopes of also submitting an application. …The requirement for a prescription can create barriers for women who don’t have easy access to a health-care provider because of cost, lack of transportation or child care, and privacy and confidentiality concerns. Making the pill available without a prescription could be particularly helpful to women in rural, poor and marginalized communities. Oral contraceptives…are available over the counter in more than 100 countries, and clinical trials have shown them to be safe and reliable. …Major medical organizations, including the American Medical Association and the American College of Obstetricians and Gynecologists, have voiced their support for making birth control pills available without prescription. …it is important that the FDA make this matter a priority.

Needless to say, libertarian-minded people are on the right side as well.

Brad Polumbo of the Foundation for Economic Education wrote in favor of reducing government intervention.

…whatever one believes about abortion, the timing of a new debate on birth control policy within the Food and Drug Administration (FDA) couldn’t be more important. The FDA just received a request from a contraceptive company seeking authorization to sell its birth control pills over-the-counter—without a prescription, as is required nationwide under current laws. …the downsides of government mandates requiring a prescription are significant. For one thing, it makes birth control harder to access for people without health insurance or the time/resources to obtain professional medical care. It also adds significantly to the cost of birth control by introducing middlemen and additional steps. …Studies have shown that, in absence of a required doctor consultation, women are able to self-screen and determine if they meet any of the conditions where one shouldn’t take hormonal birth control. …Dozens of other countries don’t require a prescription for birth control, including Mexico, Portugal, India, Greece, and Brazil. …it’s a matter of who gets to decide. Can women weigh the risks and benefits of a medication and decide for themselves? Or should that decision be made for them by supposedly benevolent bureaucrats and the nanny state?

Brad answers his own question, stating that “the answer is clear” and that the FDA should “get out of the way.”

Amen. Indeed, “get out of the way” should be our attitude about almost every action by politicians and bureaucrats.

I’ll close by making the should-be-obvious point that a belief in deregulated birth control is not the same as a belief in subsidized birth control. Especially when such policies are a recipe for higher costs and corrupt cronyism.

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