Tag: FDA

How Much Does Dr. Fauci Really Care?


Dennis Prager spoke the hard truth Monday morning: Dr. Fauci is a lifelong government employee with a salary and benefits package perfectly insulated from the economic consequences of his words. He has absolutely no skin in the game. If Dr. Fauci truly believes it is necessary to put hourly workers, waiters, bartenders, and small businesses out of work, destroying them economically, then let him and the head of the CDC ante up.

Dr. Fauci’s easiest path is completely shutdown of our economy, doing maximum damage to people who were just starting to see real success and a brighter future. He can claim noble motives, even as he seeks to avoid blame for early failures. Words of concern and supposed sympathy tripping off a career bureaucrat’s lips ring hollow and are bitter to those he ruins.

So, President Trump needs to put this to the coronavirus crew immediately, giving them the chance to volunteer giving up their salaries until the federal guidelines no longer limit American jobs. Then, if they push back, he needs to drop it on them in front of the cameras. Let’s all see their real faces and real positions when they are made to live with the real consequences of their words.

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President Trump has continued to act within the boundaries of our Constitution and laws, including in his declaration of a national emergency for COVID-19. He has not used this crisis to seize power for himself, or to direct goodies to his party, supporters, or family. I will lay out some chunks of law and the […]

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Fly Me to the Moon is Made of American Cheese – For Now


“What Sort of All Hallows’ Eve Trollop Art Thou?” PIT Seventeen asks. I’m not sure. I’m fairly sure what sort of trollop I’m not — I’m not the sort to consider glitter and body paint an acceptably modest substitute for undies. At least not on me. Nonetheless, The Sun alleges the black, bespangled, and quite bare bat bum is this Halloween’s fashion trend (any “trend” involving bums, of course, being of great interest to The Sun).

I stumbled on this so-called trend while perusing The Sun‘s investigation into snake handling, the ritual wherein Christian oppressors manhandle (“personhandle” would be more gender-neutral, but “manhandle” properly names and shames the unjust kyriarchy) innocent serpents, possibly without the serpents’ consent, purportedly for God’s glory. These oppressors — typically poor Appalachian whites — are themselves oppressed, of course, themselves victims of the same kyriarchy which enables their cross-species molestation. As one of Ricochet’s resident reptilians (I only self-identify as human online), I ought to have been outraged by the speciesist presumption that conscripts nonhuman species into human worship without even asking permission. Instead, I got distracted by sparkly bums.

Jim Geraghty of National Review and Greg Corombos of Radio America serve up only good martinis today, although the last one comes with a twist.  They cheer Congress and President Trump for enacting “Right to Try” legislation, allowing terminally ill patients to undergo promising treatments not yet approved by the Food and Drug Administration.  They also get a lot of enjoyment out of the excerpt from an upcoming HBO documentary that shows Obama Deputy National Security Adviser Ben Rhodes truly speechless after Donald Trump was declared the winner on Election Night 2016.  And just two days after ABC fired Roseanne Barr for her horrible tweet about Valerie Jarrett, Samantha Bee puts the left on the spot after using a vile word to describe Ivanka Trump.

FDA Asks Diarrhea Treatment to Contain Itself


Over a year ago, I noted that both the DEA and NIDA had expressed concern over the diarrhea treatment loperamide, widely known by the brand name Imodium. Loperamide is an opioid that, with normal use, mostly stays in the gut where it belongs, but which, if it’s taken in massive doses or combined with a P-glycoprotein inhibitor, works its way into the bloodstream and crosses the blood-brain barrier for a pathetic sort of high. Or, if you believe methadone treatment works, the high becomes somewhat less pathetic: loperamide has gotten a reputation among addicts as the poor man’s methadone, a means of easing withdrawal for those done with the dope.

One reason methadone is supposed to work as an addiction treatment is that it’s metabolized so slowly. It has an extremely long half-life (15-55 hours) compared to heroin’s (2-3 minutes). This smooths out the highs and lows to help those treated establish a normal life. Since methadone treatment is dispensed at clinics, not by pushers, it redirects addicts’ dependency toward authorized channels, which regularizes their life in another way. Loperamide has a half-life between heroin’s and methadone’s (9-14 hours). That half-life makes loperamide tempting as “DIY methadone treatment”.

Big Government, Public Health, and E-Cigarettes, Part III


This is the last in a three-part series on e-cigarettes. Part I is available here. Part II is available here.

E-cigarettes or vapor products aren’t specifically mentioned in the Tobacco Control Act. The FDA had no expressed mandate to do anything. But that isn’t stopping them from trying. If the FDA actions are not significantly changed by the administration, the Congress, and potentially the courts, FDA regulations will certainly do more to harm public health than benefit it. The nexus used by the FDA to sweep vapor products into its regulatory regime was that nicotine in the products was “tobacco derived.” Most, or all of it, is, just like the nicotine used in gums and patches. Frankly it’s cheaper to acquire nicotine from tobacco than it is to acquire it from other plants (it’s in tomatoes, eggplant, and other nightshades) or to create it in a lab. But, as regulatory agencies often do, the FDA has indicated that they will broadly exercise authority to regulate devices (that contain no nicotine and are not tobacco-derived) or zero nicotine liquids.

Most significantly, the FDA deeming rule related to these products creates an effective ban on tens (if not hundreds) of thousands of existing products. The Tobacco Control Act and subsequent FDA regulations allowed all cigarette products sold before 2007 to remain on the market so long as they complied with existing rules. Rather than allow existing vapor products to remain on the market upon publication of the deeming rule, the FDA immediately banned any new products from entering the market and will require all existing products to complete a prohibitively expensive and largely arbitrary application process, with no clear guidance from the FDA and little or no likelihood of approval.

In this AEI Events Podcast, a group of experts convene to discuss the Food and Drug Administration’s (FDA) excessive regulation of e-cigarettes and what might be done to further encourage their use as an alternative to smoking. AEI’s Sally Satel begins by surveying the epidemiology of smoking and the potential of e-cigarettes to function as a cessation tool. In the following conversation, panelists discuss the history of e-cigarette regulation, potential legislative fixes to current regulations, and the role of pending litigation in scaling back the FDA’s regulations.

Panelists include Azim Chowdhury (Keller and Heckman LLP), Greg Conley (American Vaping Association), Sally Satel (AEI), Saul Shiffman (University of Pittsburgh), and Alan D. Viard (AEI). The discussion is moderated by Stan Veuger (AEI).

Big Government, Public Health, and E-Cigarettes, Part II


This is the second in a three-part series on e-cigarettes. Part I is available here.

Vapor products contain no tobacco. They produce no smoke. Most contain nicotine and it’s the same nicotine used in FDA-approved gums and patches. While the devices look different, they all operate by heating a liquid solution (propylene glycol and/or vegetable glycerin, nicotine and flavor) to produce an aerosol. Importantly, the products allow users to replicate the act of smoking. Like smokers, vapers engage hands and mouths in a ritual similar to the one they practiced every day for many years as a smoker. Like a smoker, the vaper inhales and exhales and can both feel and see the vapor produced. But unlike cigarette smoke, the aerosol dissipates quickly. There’s no smoke, no tar, and no carbon monoxide – the things that cause half of all smokers to get sick and some to die. Nicotine doesn’t cause lung cancer or make smokers sick. As far as its heath impact, it’s comparable to caffeine. As long as you don’t consume caffeine or nicotine through smoking, most people can use it without incident for an entire adult lifetime. Nicotine also seems to bring health benefits for some.

There is little doubt that part of the consternation of tobacco control groups and regulators simply arose from the fact that products are called e-cigarettes and using them resembles smoking. That reaction is emotional, not rational. Perhaps we can appreciate that it motivates tobacco controllers to investigate further. Rather than investigate and try to understand, however, the FDA initially stepped in and attempted to shut the industry down by banning the importation of e-cigarettes as unapproved medical devices. And electronic cigarette company, NJOY (previously Sottera), was targeted by the FDA and had imported products seized at the US border. NJOY fought the federal government, ultimately winning in court.

Big Government, Public Health, and E-Cigarettes, Part I


Since the US Surgeon General’s report on smoking and health in 1964, governments (local, state, federal) and tobacco control groups have waged a comprehensive campaign to encourage smokers to quit and discourage non-smokers from starting. They have used every tool available with cost being of little concern.

They’ve educated about the harms associated with smoking. When that didn’t do the trick, they attempted to shock and scare smokers away from the habit with graphic images. They’re in a half-century cycle to fight for increased taxes. They’ve banned smoking anywhere people congregate. They’ve filed individual lawsuits, class action lawsuits, and lawsuits from state attorneys general (resulting in the tobacco master settlement agreement that forced tobacco companies to pay billions to the states, all costs passed on to consumers via increased prices).

They’ve restricted the ability of companies to sell and market products, restricted use of brand-name advertising and eventually they decided scaring children might discourage them from becoming smokers. They also thought sending terrified kids home to shame their smoking parents could only benefit their cause.

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This is just a short fun story from a while back that I found in my drafts, and quickly finished. I was sitting in the dining hall with a good friend and two others, and I brought up the failings of the FDA. (It was relevant enough.) Two of my tablemates launched into, “Well, they’re […]

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Richard Epstein responds to the recent controversy over sharp increases in the price of EpiPens and explains the economic dynamics underpinning the larger debate about prescription drug costs.

What Illegal Substance Do You Crave?


The Federal Government has, for quite a long time, banned the sale or importation of a very wide range of products. Having never had access to those products, most Americans don’t know what they are missing. But they are a loss nevertheless.

I wrote this post to find out what I am missing. But I can start by sharing an example or two of what Americans lack, courtesy of a stupid federal bureaucracy:

The FDA’s Slow Motion Ban of E-Cigarettes


shutterstock_237371161Last year at my blog Overlawyered I wrote about one of the rare instances in which a widely watched health indicator was headed rapidly in a favorable direction:

Actual cigarette smoking among teens, the kind that requires inhaling carcinogenic products of combustion, is down a startling 25 percent in one year and nearly 42 percent since 2011. The reason is the rapid substitution of vaping or e-cigarettes, which hold singular promise as a harm-reduction measure for those drawn to the nicotine habit. Great news, right?

Well, not great news if you’re the present leadership of the federal Centers for Disease Control (CDC), whose director Thomas Frieden has railed against vaping, or the federal Food and Drug Administration, which has now published regulations likely to wipe out most or all of the vaping option in what Jacob Sullum describes as a “slow-motion ban.”

From the Editors’ Desk: Senate Food (& Drug) Fight!


shutterstock_243773839Via the WSJ, the parties’ attitudes on the subject could hardly be in starker contrast:

For weeks, members and staffers of the Senate Health, Education, Labor and Pensions Committee have been trying to find common ground on the legislation. Republicans wanted to smooth the regulatory path for drug and medical device approvals, while Democrats strove to increase funding for medical research and find ways to keep drug prices in check. But in recent weeks, Democrats balked at several industry-sought measures they believed would lower the bar too much on the safety of products approved at the FDA, according to people familiar with the talks. These measures supported by Republicans would have, among other provisions, reduced FDA scrutiny of certain laboratory tests’ accuracy and of medical software.

On Thursday, Democrats on the panel confirmed they were offering their own version that would increase research funding for the National Institutes of Health and the FDA, but avoid some of the regulatory provisions. They also sought ways to cut prices of cancer, hepatitis and other expensive drugs. So now, the two parties are offering versions of an NIH funding bill that are poles apart. This strife is unusual for the HELP committee, which has been relatively bipartisan and cooperative for decades. Chairman Lamar Alexander (R., Tenn.) and the panel’s top Democrat, Sen. Patty Murray of Washington, for example, negotiated a rewrite of K-12 education programs last year.

The Other Drug War


Earlier this month, the Food and Drug Administration rejected the application of Biomarin Pharmaceutical to market its drug Kyndrisa™ (drisapersen) for use in the treatment of Duchenne muscular dystrophy. The FDA, as is often the case when it rejects a drug application, listed all sorts of technical reasons why the data presented was not sufficient to establish by respectable scientific means that the drug in question was safe and effective in its intended use. Without question, much evidence from the clinical trials revealed serious complications from the drug’s use, including blood-platelet shortages that were potentially fatal, kidney damage, and severe injection-site reactions. But the no-treatment alternative could prove far worse.

Duchenne is a rare but fatal genetic disorder that attacks only young boys, roughly 1 in 3,500 to 5,000. Typically, it first manifests itself between two and five years of age. With time, it relentlessly weakens the skeletal muscles that control movement in the arms, legs, and trunk. Most of its victims are wheelchair-bound between the ages of seven and 13. By 20, many have died.

The FDA’s Looming Regulatory Onslaught Threatens the Freedom to Vape


shutterstock_299809835Americans who are trying to kick their nasty smoking habit have found healthier alternatives in e-cigarettes and vapor products that could, quite literally, save their lives. But the bureaucrats at the Food and Drug Administration are trying to put this $3.5 billion industry out of business.

Small mom-and-pop shops have sprung up across the country to meet the growing demand for vapor products, which allow users to refill their vaporizers with their favorite e-juices. Separately, big tobacco companies have invested in non-refillable e-cigarettes.

Though these products are not always tobacco-free; there’s no ash or smoke involved. But they do contain nicotine, which users can gradually reduce if they choose. E-cigarettes and vapor products contain far fewer chemicals and carcinogens than traditional tobacco cigarettes, making them safer for the users, as well as those around them. “[T]he levels of potentially problematic substances in e-cigarette aerosol,” Reason’s Jacob Sullum wrote in March, “are about the same as those detected in ambient air.”

Denying The Last Gamble


IMG_0660Public policy, like life, is always a matter of trade-offs. The difficulty often arises not so much in determining what is good and what is bad, but in comparing goods’ value to each other, especially when they come into conflict. Further complicating matters, this weighing of risk varies for any given individual depending on his situation: under some circumstances, risks that would be otherwise unthinkable may well be prudent and wise. And the only thing more difficult than anticipating changed circumstances is accurately forecasting people’s reaction to them.

This complexity — or, more specifically, the inherent difficulties in understanding this complexity — is one of the best arguments against Progressivism: no one is smart enough to be a philosopher king and attempts to approximate one through law and regulation are doubly doomed to failure. Leaving people to make their own choices and evaluate their own risks not only wins on its philosophical appeal to liberty (no small thing that), but also on terms of pure pragmatism.

It’s hard to imagine an issue that better illustrates the absurdity — and immorality — of Progressive’s we-know-what’s-best-for-you attitude than when it comes to access to experimental drugs for the terminally ill. Whatever benefits the FDA provides in terms of public safety and accountability (I’ve mixed feelings on the matter), they’re non-existent when it comes to dealing with the terminally ill. In what may well be a first, both National Review’s Wesley Smith and Reason’s Nick Gillespie both applaud the California Legislature (yes, you read that right) for passing a bill that would lax regulations for the dying which, unfortunately, met a sad end under Gov. Jerry Brown’s veto pen. As Smith notes in what can only be described as one of the most perfect ironies of all time, Brown also recently signed legislation — and with much fanfare — allowing assisted suicide.

FTC to FDA: Do Your Job So We Can Do Ours


shutterstock_125410652Regulation is a tricky matter, filled with tension. Too little and you end up with fraud and harm; too much and you stifle innovation. Too little input from industry and you get decisions ignorant of conditions on the ground; too much and you have regulatory capture. When it comes to homeopathy, the Food and Drug Administration seems to have managed to make all of these errors at once — including ones that should be mutually exclusive.

A few months back, the FDA sought public comment on its regulatory regime for homeopathy. Both homeopaths and science-based activists flooded them with material. The most surprising comment, however, came from another organ of the government: a pointed and bitter memorandum from the Federal Trade Commission, essentially telling its fellow regulators to stop making the FTC’s job impossible by abdicating the FDA’s duty to evaluate homeopathic products’ efficacy and safety in the same way they do normal drugs.

As described by the blog Science-Based Medicine, who — rightly, I think — consider homeopathy a fraud:

Purity Before Safety (or Science)


shutterstock_88312414The ‘war against tobacco’ has long since ceased to have much to do with saving lives. Here’s the latest bone-headed example:

(Reuters) – Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday.

The Stockholm-based company is seeking FDA approval to remove warnings about mouth cancer, gum disease and tooth loss from its snus products and to state that they present a “substantially” lower risk than cigarettes.