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All Reason.com articles with the "FDA" tag.



Published: Sun, 18 Feb 2018 00:00:00 -0500

Last Build Date: Sun, 18 Feb 2018 14:07:59 -0500

 



Congress Has Failed (Yet Again) to Close the Martin Shkreli Loophole

Thu, 15 Feb 2018 15:20:00 -0500

Prescription drug companies sometimes use a legal loophole called "restricted distribution" to undermine their generic competitors. The CREATES Act, sponsored by a transpartisan group of senators, would have curtailed the practice, but last week Majority Leader Mitch McConnell (R-Ky.) excluded the bill from the budget agreement. As a result, Americans will continue to pay more than they should for certain prescription drugs. Many Americans are at least vaguely familiar with restricted distribution, thanks to the most infamous pharmaceutical executive to take advantage of it, Martin Shkreli. Shkreli, you may remember, jacked up the price of a drug called Daraprim, which was approved by the Food and Drug Administration in the 1950s and has been used for decades as a treatment for parasites that infect people with compromised immune systems. The patent for Daraprim expired more than 40 years ago, but it's still the only FDA-approved version of pyrimethamine currently on the market in the U.S., which means it has no generic competitor. (The FDA approved a slightly different formulation of pyrimethamine as a malaria treatment in 1981, but it has since been discontinued.) For a long time, American patients didn't really need a generic version of Daraprim, because it cost around $13.50 per 25 milligram pill and is taken for a short period of time. For immunocompromised adult patients who have the toxoplasmosis parasite, the FDA recommends taking 50 to 75 milligrams of Daraprim a day for up to three weeks, followed by half that dosage for an additional four to five weeks. So at the high end, an adult course of Daraprim therapy for a U.S. patient used to cost around $1,350 total. While that might not seem cheap, it was a drop in the bucket compared to the cost after Turing Pharmaceuticals, Shkreli's company, bought the rights to Daraprim and jacked the price up to $750 per pill in 2015. That move increased the cost of one course of treatment to around $75,000. At that point you might have expected another company to jump in and start offering a generic version of the drug. But Shkreli used a regulatory loophole to keep that from happening. You see, when a generic manufacturer wants to create a cheap version of a branded drug, it has to buy thousands of doses from the manufacturer in order to run comparison tests. Generic manufacturers use the results of these tests to prove to the FDA that their version is identical to the branded drug that the agency has already approved. More often than not, the company that holds the marketing and distribution rights to a branded drug will sell those comparison doses to the generic manufacturer without being obstructionist, because that's the trade-off for receiving a 20-year monopoly by way of a drug patent: The branded manufacturer gets to charge whatever they want for years and years without facing competition, and in exchange for that government-backed monopoly, it's supposed to sell equivalency samples to generic companies. But what if the company is run by an unscrupulous asshole like Martin Shkreli? Then it might opt to put the drug into what's called "restricted distribution," which means no distributor anywhere can sell comparison samples to a generic manufacturer. The FDA originally created the concept of restricted distribution to limit the availability of drugs that might be dangerous. Methadone, for instance, was first approved in the 1940s as a painkiller. In the 1970s, the FDA restricted its availability because regulators didn't want the opioid used for anything other than the treatment of opioid dependence. Even today, methadone can be dispensed only in highly regulated settings and only for one approved reason. In 2007, Congress empowered the FDA to create an entire system of safety controls beyond restricted distribution, and the agency now requires the manufacturers of certain substances to develop Risk Evaluation and Mitigation Strategies (REMS) to prevent misuse and abuse of potentially problematic compounds. The list of approved drugs that the FDA says must have an REMS [...]



The FDA Is Still Trying to Ban Kratom, a Potential Solution to the Opioid Epidemic

Mon, 12 Feb 2018 11:10:00 -0500

Last week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government's effort to slow usage of this alternative pain reliever. Due to the substance's similar chemical structure to traditional opioids, FDA Commissioner Scott Gottlieb suggested using kratom to treat withdrawals poses a public safety risk: We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency's standard for approval. While kratom is currently legal under federal law, this announcement follows the FDA's decision to block the importation of kratom products. In 2016, the Drug Enforcement Administration tried to place kratom in the same class of illegal substances as heroin, but a public outcry—and even some Congressional support for kratom—stopped that motion. Now that the FDA has conducted further medical analysis of kratom, the drug is more likely to be added to the "schedule" of restricted drugs. The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA's November 2017 report. While the report suggests these cases "underscore the serious and sometimes deadly risks of using kratom," it is clear that the FDA is reaching. In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played. The FDA cites one case where a 22-year-old man consumed a kratom mixture he ordered online along with an "unknown tablet." This consumption "was followed by an incident, during which the patient fell from a window of the first floor before going to bed" without receiving medical treatment. He was found dead the next morning, and the medical examiner determined that he choked on his vomit while he slept. The man had a history of mental illness, and a prescription drug history that included pipamperone (an antipsychotic used for treating schizophrenia), fluoxetine (an SSRI used to treat anxiety, OCD and depression), queiapine (another antipsychotic), olanzapine (another antipsychotic), etizolam (a benzodiazepine analog), pregabalin (a nerve pain medication often used to treat seizures), lorazepam (a benzodiazepine) and triazolam (a benzodiazepine used to treat severe insomnia that can also cause psychotic episodes). Oh, and he also used kratom. The FDA report does not discuss the extent to which these drugs may have contributed to the man's mental state, instead summarizing his demise with this line: "The patient was found dead in his bed on the morning following the consumption of an herbal mixture." Another kratom user in the FDA's report died from deep vein thrombosis—a type of blood clot the medical examiner says may have been related to the man suffering from obesity. While there is some research suggesting a correlation between DVT and intravenous opioid use in women, kratom is taken orally and the subject in this report was male. Deep vein thrombosis can also be hereditary, and the man had a long history of medical problems. As with all the incidents in the FDA's report, these two deaths are associated with kratom only because kratom was found in each man's system. While there is no question that kratom is a drug, the FDA is grasping for a reason to ban this substance. The total number of deaths associated with kratom is dwarfed by those attributed to common over the counter and non-opioid prescription drugs, a point Reason's Jacob Sullum has made before. Kratom is a popular alternative medicine for those suffering from chronic pa[...]



FDA Begins Implementing Awful Food-Safety Law

Sat, 03 Feb 2018 08:00:00 -0500

America's farmers are on the alert this week as key provisions of the Food Safety Modernization Act (FSMA) begin to take effect. The law, which is being rolled out by the Food and Drug Administration (FDA) over several years, could have far-reaching implications for who grows—and doesn't grow—the food you buy. When Congress passed FSMA (pronounced FIZZ-muh) in late 2010—President Obama signed it into law during the first days of 2011—supporters touted the law as the most sweeping update of our nation's food-safety laws in more than 75 years. But both the law and its implementation are controversial. Many small farmers feared—and still fear—that the new regulations and high costs of complying with the law could squeeze them out of business. As evidence, they point to the giant farms and food producers who supported the law. While FSMA contains several provisions, one key facet of the law requires the FDA to "establish science-based minimum standards for the safe production and harvesting of fruits and vegetables." Bigger farms must comply sooner. Hence, as of this week, the produce rules apply only to America's largest farms. That means that this year, farms with more than $500,000 in sales will have to comply with FSMA. Next year, the rules will also cover farms with between $250,000 and $500,000 in sales. And in 2020, the rules will cover very small farms—those with revenue between $25,000 and $250,000. While this gradual implementation is likely better for small farmers than the alternative—being forced to comply right now—that hasn't allayed their fears. Many of those fears pertain to compliance costs. The relative compliance costs for small and large farms are stark. As I've noted previously, the FDA estimates FSMA will cost America's small farms about $13,000 each per year and its larger farms about $30,000 per year. That means that for some small farmers, compliance costs could eat more than half of their revenue. For larger farms, compliance costs will amount to less than one percent of revenue. As I detail in my book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable, small farmers' concerns about that part of the law have been legion. This week, one Maine farmer shared his concerns about the law. Farmer Goran Johanson, while embracing some of what FSMA requires, says the law will place "a huge financial burden on us as farmers." He worries "there could potentially be a lot of infrastructure needs necessary" at his farm, including that he'll have to scrape together funds "to build a new produce packing house that will have washable surfaces on everything, which is an expensive investment." Just how much will FSMA benefit consumers? According to the FDA itself, not much. Even if FSMA is implemented perfectly, the law won't make our food supply much safer. That's according to the FDA's best-case estimates which, I wrote in 2014, would mean "a paltry reduction in cases of foodborne illness of between 3.7 percent and 5.4 percent." Again, that's the best-case scenario. A more likely outcome, I estimated, also using FDA data, is that foodborne illness cases might drop by around 2.6 percent. Why such little impact? As I detailed in 2015, FDA regulations are only capable of preventing, at most, "only one out of every five cases... of foodborne illness." That's because four of every five cases of foodborne illness can be traced to causes that have nothing to do with foods regulated by the FDA. Congress never should have passed a law with such high costs and such little return. Around the country, state agriculture departments and agricultural extension agents are working feverishly to help local farmers prepare to comply with the regulations. In five years, when there are even fewer small farmers than there are today, we'll be able to look back to this week as the beginning of that sad and unnecessary end.[...]



Right To Try Laws Are a Fine Start. Comprehensive Reform of the FDA's Drug Trials Would Be Better.

Fri, 02 Feb 2018 13:35:00 -0500

In his State of the Union address this week, President Trump urged Congress to pass right-to-try legislation that would allow patients suffering from terminal illnesses to access new drugs and other treatments that have undergone preliminary Food and Drug Administration (FDA) safety trials, but have not yet been shown to be efficacious in clinical trials. It's a good start. But it's no substitute for a top-down overhaul of the agency's entire process for testing and approving new drugs. Traditionally, patients only get access to new drug treatments once they are approved by FDA after passing through three phases of clinical trials. The goal of phase 1 trials is to test new compounds for patient tolerabilty and safety. Typically 20 to 100 patients participate in Phase 1 trials. Phase 2 trials aim to determine proper dosage levels for new treatments while also checking for further evidence that the new compound is safe and possibly efficacious. Several hundred patients may be enrolled in Phase 2 trials. Phase 3 trials focus on efficacy and monitor for adverse reactions and may involve thousands of participants. In Phase 3 trials, the efficacy of new medications is often benchmarked against current treatments. One recent report estimates that only 1 in 10 new drugs that enter clinical trials are eventually approved by the FDA. It is noteworthy that only 31 percent of drugs that currently enter Phase 2 studies go on to Phase 3 trials. In other words, more than two-thirds of biopharmaceuticals that pass through Phase 1 safety trials end up being deemed insufficiently efficacious as treatments for the diseases at which they are targeted. So far, 38 states have passed right-to-try legislation. Since drugs and medical treatments are regulated at the federal level, state laws so far have had little apparent effect on enabling patients gain access to experimental treatments. Consequently, right-to-try proponents want Congress to pass legislation that would allow patients with terminal illnesses to seek access to experimental drugs that have passed through Phase 1 safety trials. Many drugmakers have been reluctant to offer treatments not yet approved by the FDA on a right-to-try basis for fear being sued by patients or their heirs should bad outcomes occur. In addition, they worry that any adverse events among right-to-try patients would delay eventual FDA approval. Consequently, the proposed federal legislation provides that the makers of experimental drugs could not be held liable by patients for any untoward outcomes and that FDA regulators would be barred from taking into account the results of right-to-try treatments when reviewing such drugs for approval. Opponents of right-to-try legislation fear that it would enable unscrupulous practitioners to sell the moral equivalent of snake oil to desperate people. In addition, opponents point out that the FDA already has a compassionate use program that allows patients and their physicians expanded access to investigational drugs. New FDA administrator Scott Gottlieb recently announced changes that aim to speed up the process of providing access to drugs and devices for patients with serious conditions (generally prior to product approval), when there is no therapeutic alternative. In addition, the agency provided guidance to drugmakers clarifying that suspected adverse reactions from experimental treatments administered on a right-to-try basis must be reported "only if there is evidence to suggest a causal relationship between the drug and the adverse event." The FDA does also note that greenlighting access to experimental treatments does not require drugmakers to provide them to patients. Right-to-try is at best a band-aid. Comprehensive reform of the clinical trial process is a better and cheaper way to speed new medications to the bedsides of patients. As I have earlier argued: The FDA should be modernized so that new treatments become available to patients once they have made it through the Phase [...]



Addicts Use Imodium to Help With Detox. That's a Terrible Reason for the FDA to Make It Harder to Get.

Wed, 31 Jan 2018 14:00:00 -0500

Over-the-counter medicine frees Americans to treat minor health issues without first consulting an expert. For no ailment is this freedom more of a godsend than a pesky case of the runs. You can grab a box of Imodium A-D (or the store brand of the active ingredient, loperamide), walk to the checkout counter, and pay, all without breathing a word about your messy butt to anyone. But now the opioid crisis has driven regulators into absurd fits of caution. The Food and Drug Administration (FDA) wants to make loperamide less accessible because opioid addicts might abuse it. And some in the health industry argue that you should have to ask a pharmacist and present a government-issued ID to buy the drug, as is currently the case with pseudoephedrine. In a statement published Tuesday, the FDA announced that it "continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product." In response to these reports, the agency wants loperamide manufacturers to limit the number of doses per package to a few days' worth and to make the pills available only in blister packs rather than bottles. Loperamide is a very, very mild opioid, and like all opioids, it slows down the muscles that send poop through your pipes. But unlike most other opioids, it's doesn't affect other parts of the body unless you take a shit-ton. The maximum therapeutic dose is 16 milligrams in the course of a day; people using it either to get high or to chase away withdrawal symptoms will take more than 100 mg. Doses that high can (but don't often) cause "adverse cardiac events." That's just a mild inconvenience, you might object, if the changes will protect people's hearts. But this week's FDA notice does not say how many people have died or been seriously injured from loperamide overdoses, how many adverse events might be avoided by changing to blister packs, or how much retooling loperamide production facilities will cost manufacturers (and ultimately consumers). These are not small asks. The answer to the first question tells us whether the second two are even worth considering; the second question helps us understand whether the imposition implied by the third is reasonable. Since the FDA isn't being forthcoming, how might we determine how many people are abusing loperamide? A good start would be to look at toxicology and mortality data. Here's the research I found on loperamide abuse published in the last two years: According to a 2016 study of loperamide-related deaths in North Carolina, published in the Journal of Analytical Toxicology, the North Carolina Office of the Chief Medical Examiner found above-therapeutic levels of loperamide in 21 deceased persons between 2012 and 2016; the drug is said to have played some role in 19 of those cases. In only one case—that of a 21-year-old male who had a history of overdoses—was loperamide the only drug present. A review of New York Poison Control data published by the Centers for Disease Control and Health and Human Services uncovers 22 cases of intentional loperamide abuse between 2008 and 2016; 15 of the patients had a history of opioid abuse. The average daily dose was 358 mg, and the full range was 34 mg (twice the daily recommended maximum) to 1,200 mg (75 times the maximum). The report does not disclose any fatal overdoses. The same study looked at the National Poison Database System and found 179 cases of intentional loperamide abuse from 2008 to 2016. The average loperamide dose across those cases was 196 mg, ranging from 2 mg to 1,200 mg. The paper includes clinical outcomes for 132 of those cases: 66 patients suffered "life-threatening symptoms or residual disability"; four of them died. A 2017 review published in the Journal of Emergency Medicine found a much larger number of loperamide misuse/abuse cases between 2009 and 2015. The researchers found 1,925 pois[...]



Trump's Prescription Drug Price Controls Would Save Us Money. They Would Also Make Us Sicker.

Tue, 30 Jan 2018 23:28:00 -0500

"One of my greatest priorities is to reduce the price of prescription drugs," declared President Donald Trump during his State of the Union address tonight. He added, "In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down." The president is reprising his claims in his first post-election press conference last year. Last January, President Trump declared that pharmaceutical companies are "getting away with murder" by pricing their drugs too high. "Pharma has a lot of lobbies, a lot of lobbyists, and a lot of power. And there's very little bidding on drugs," Trump said in January. "We're the largest buyer of drugs in the world, and yet we don't bid properly." The president is right that drugs often cost far less in other countries than they do here. Why? Two words: Price controls. Basically, the government health care systems in other countries simply tell pharmaceutical companies what they will pay for their drugs. Drug companies put up with price controls in other countries because they can still make money because the controlled prices still cover the costs of making the marginal pill. Consequently, paying for the global costs of research and development for new drugs is made up by charging Americans higher unregulated prices. Drug price controls would indeed save the government and consumers money, but at the cost of shorter and sicker lives. As I reported earlier: A 2013 study by Dean Baker, co-director of the Center for Economic and Policy Research, ...calculated that drug price controls could save Medicare between $24.8 and $58.3 billion annually. On the other hand, less revenue to pharmaceutical companies means less money devoted to research and development. A separate study, published in Managerial and Decision Economics in 2007, estimated that cutting prices by 40 to 50 percent in the U.S. will lead to between 30 and 60 percent fewer R&D projects being undertaken. Reduced investments in pharmaceutical R&D consequently results in reduced numbers of new drugs becoming available to patients. A 2009 study in Health Affairs calculated that as a result of fewer innovative pharmaceuticals being developed, average American life expectancy in 2060 would be around 2 years lower than it would otherwise have been. Over at STAT, Robert J. Easton, co-chairman of the medical business consultancy Bionest Partners, cogently explains: If U.S. drug prices come under bureaucratic control, as they have in most of Europe and Japan, it will be a different story. Little pharmaceutical innovation occurs in price-control jurisdictions. The United States has always, by a large margin, led the world as a source of new drugs, and that lead has widened as Japan and Germany have imposed price controls over the past few decades. All major international pharmaceutical companies, without exception, have instituted R&D and commercial operations in the U.S. to take advantage of its pricing environment. If price controls pressure the U.S. industry into a more conventional process industry model, like that of the chemical industry, pharmaceutical R&D budgets would be slashed. We can hope that the president is actually signaling that his administration intends to rev up pharmaceutical price competition. The good news is that Scott Gottlieb, the new head of the Food and Drug Administration intends to increase competition that by hastening the approval of hundreds of generic drugs that have been stuck the agency's approval pipeline. An FDA study has found that as the number of competing manufacturers for a drug goes up, the price falls dramatically. When two companies compete, the price falls an average of just 6 percent; when there are nine competitors, the price drops by an average of 80 percent. If President Trump and Congress seek to[...]



Trump Promotes 'Right to Try' Experimental Treatments for Terminally Ill Patients in SOTU Address

Tue, 30 Jan 2018 22:15:00 -0500

(image) President Donald Trump took a moment in his State of the Union address to support a federal law to allow terminally ill patients access to experimental drugs that haven't been fully approved yet by the Food and Drug Administration (FDA).

It was a short shout-out, but significant:

We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives.

People who are terminally ill should not have to go from country to country to seek a cure—I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the "right to try."

Close to 40 states already have laws that allow Americans access to drugs earlier in the testing stage if they've got terminal illnesses. But there's no federal permission, so there are concerns that the FDA and federal enforcement could override state laws.

Congress nearly passed a law last year, but it didn't make it to the finish line. A new lobbying effort launched earlier in January by groups like Freedom Partners and Americans for Prosperity to try to push it through. According to The Hill, they have an ally in Vice President Mike Pence as well. He signed Indiana's version of the bill into law back when he was governor.

Eric Boehm wrote about last year's efforts and some nanny-ish foot-dragging from legislators who for some reason think that earlier access to drugs could somehow make things worse for people who are dying:

"The legislation being proposed could expose critically ill patients to greater harm," worries Rep. Frank Pallone, D-N.J., minority chairman of the committee. Other Democrats expressed similar worries, even while expressing sympathy for patients who are asking little more than for government to get out of the way during the final days of their lives. There are "very legitimate frustrations with the current system," for allowing patients access ot non-FDA-approved drugs, admitted Rep. Gene Green, D-Texas. But those problems are not a good reason to remove the FDA from the process, Green said.

Currently, the FDA runs a so-called "expanded access" program for terminally ill patients who cannot get into drug trials for various reasons. According to a Government Accountability Office report published in July, FDA had approved 99 percent of the 5,800 requests made from 2012 through 2015 by patients seeking access to the program.

Lack of access, then, is not the problem, but time is. Patients with terminal illnesses can wait as little as a few hours to as long as 30 days for the FDA to respond to a request to try a new drug, according to the GAO, and that wait could ending any slim hope of finding a successful treatment. If you think dealing with bureaucrats is awful when you're standing in line at the DMV or applying for a passport, imagine having to go through that same process when your life is on the line.

These terminally ill people should be able to decide for themselves how much they're willing to risk. Watch below for a look at the "Right to Try" movement from ReasonTV:

src="https://www.youtube.com/embed/nerWf9Vydn4" allowfullscreen="allowfullscreen" width="560" height="340" frameborder="0">




Nonsensical FDA Ban On Vaping Products Faces 3 New Legal Challenges

Tue, 30 Jan 2018 11:10:00 -0500

A 2016 ruling by the Food and Drug Administration effectively banned new vaping products from the market unless they undergo an extensive, and expensive, approval process that was designed for traditional cigarettes. The so-called "deeming rule" also prevents e-cigarettes from being marketed as safer alternatives to traditional cigarettes or as a way to help smokers quit. Lawsuits filed Tuesday in federal courts in Minnesota, Texas, and Washington, D.C., ask judges to overturn that ruling on that grounds that such regulations must come from Congress, or at least from presidential-appointed agency heads. The decision to force electronic cigarettes and other vaping products to comply with the 1997 Tobacco Control Act is a head-scratcher for a number of reasons—not least of which being that e-cigarettes contain no tobacco. Forcing e-cigarettes to comply with a regulatory scheme devised for cigarettes, one that predates the introduction of e-cigarettes into the marketplace, has hurt vaping businesses and made it harder for smokers to switch from combustible cigarettes to the relatively safer electronic variety, which use a heating element and nicotine-laced liquids. Under the terms of Tobacco Control Act, vaping manufactures and sellers cannot market their products as a more healthy alternative to cigarettes that help smokers quit, despite the fact that study after study has shown that they are. Steve Green, owner of California-based Mountain Vapors and one of the plaintiffs in the lawsuit filed Tuesday in federal court in Washington, D.C., says the FDA's rule-change has damaged his business and his customers. Worse, it's stopped him from being able to share his personal story of using e-cigarettes to kick his smoking habit. "For years I smoked two-and-a-half packs of cigarettes a day, and it nearly gave me emphysema," says Green. "Vaping freed me from my addiction and the doctor says I've recovered." Vaping businesses in Michigan and North Dakota are also part of the lawsuit launched in D.C. Separately, a lawsuit was filed in federal court in Minnesota by a group of four small vape shops in the state and the Minnesota-based nonprofit Tobacco Harm Reduction 4 Life. Joosie Vapes, a vape shop in Mesquite, Texas, filed a federal lawsuit in the state. All three challenges are being backed by the Pacific Legal Foundation, a libertarian law firm, and all three make the same basic argument about the legality of the Food and Drug Administration's decision to apply the Tobacco Control Act to e-cigarettes. "Rules that affect the American people must be issued by officials who are answerable to the political process, not by bureaucrats who have no political accountability," says Thomas Berry, an attorney with PLF. "The Constitution requires that regulations with the force of law must be approved by agency executives nominated by the President and confirmed by the Senate." By contrast, the FDA's deeming rule was issued by Leslie Kux, an associate commissioner for policy, a career civil service employee at the FDA. The consequences of that rule are significant. Bringing any new e-cigarette products to the market will now require an application to the FDA and the administration's approval. That process will cost from $182,000 to $2 million for e-liquids and from $286,000 to $2.6 million for e-cigarettes themselves, the FDA estimates. That's a prohibitively high expense for many potential products, and it leaves bigger companies in control of the e-cigarette market. Berry says the FDA's rule also flaunts the First Amendment by forcing vaping businesses to "run a regulatory gauntlet" before being allowed to speak openly about their products. Under the Tobacco Control Act, which prohibits unapproved "modified risk" claims, e-cigarette companies are not allowed to advertise the main advantage of their products—that they are healthier than traditional[...]



E-Cigarettes Can Be Lifesavers

Wed, 24 Jan 2018 00:01:00 -0500

This week the National Academies of Sciences, Engineering, and Medicine (NASEM) weighed in on the question of whether e-cigarettes are a public health menace or a public health boon. The answer is yes, according to a NASEM report published on Tuesday. The report, which was sponsored by the Food and Drug Administration (FDA), concludes that "e-cigarettes cannot be simply categorized as either beneficial or harmful to health." While that is true in principle, the report gives too much weight to scenarios in which these products could be harmful, even while confirming that they dramatically reduce exposure to toxins and carcinogens for smokers who switch to them. NASEM's advice is important because it will guide the FDA as the agency decides how to regulate the vaping industry, which last year got a four-year reprieve from rules that threatened to drive the vast majority of companies out of business. The demands that the FDA ultimately imposes on manufacturers of vaping equipment and liquids will affect the options available to consumers and their knowledge of them, which in turn will determine the extent to which they take advantage of products that could save their lives. The NASEM report, which is the work of a committee chaired by University of Washington toxicologist David Eaton, acknowledges the harm-reducing potential of e-cigarettes. "E-cigarette aerosol contains fewer numbers and lower levels of most toxicants than smoke from combustible tobacco cigarettes does," Eaton et al. say. "Laboratory tests of e-cigarette ingredients, in vitro toxicological tests, and short-term human studies suggest that e-cigarettes are likely to be far less harmful than combustible tobacco cigarettes." When people who otherwise would be smoking use e-cigarettes instead, that represents an unambiguous gain from a public health perspective, which seeks to minimize disease and preventable death. "If e-cigarette use by adult smokers leads to long-term abstinence from combustible tobacco cigarettes," the report says, "the benefit to public health could be considerable." But Eaton and his colleagues worry that e-cigarettes also could increase tobacco-related morbidity and mortality if they encourage teenagers to smoke. Depending on how big that effect is, they say, it might even outweigh the benefit from smoking cessation among adults. That concern seems wildly implausible in light of current trends. Cigarette smoking by teenagers has continued to fall despite a surge in experimentation with vaping, and last year it reached the lowest level ever recorded by the Monitoring the Future Study, which began surveying high school students in 1975. Two other factors make it unlikely that significant numbers of teenagers become smokers after getting hooked on nicotine in e-cigarettes. The vast majority of nonsmoking teenagers who vape do so only occasionally, and most of them use nicotine-free e-liquids. Against these facts, the NASEM report cites studies that find teenagers who try vaping are more likely than those who don't to subsequently try smoking. According to Eaton et al., these studies amount to "substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults." As the report acknowledges, however, these observational studies do not distinguish between correlation and causation. They may simply show that teenagers who are inclined to try vaping are also inclined to try smoking. Such research cannot tell us how many of these teenagers become regular smokers or whether they would have experimented with tobacco even if e-cigarettes did not exist. Under the collectivist calculus prescribed by the Family Smoking Prevention and Tobacco Control Act, Eaton et al. note, it is not enough to show that e-cigarettes are much less hazardous than the conventional kind and theref[...]



'Food Police' Thriving Under Alleged Deregulator Trump

Sat, 06 Jan 2018 08:00:00 -0500

Last week, a fantastic front-page New York Times article looked at the phenomenon of regulatory fatigue, set against the Trump administration's claims to be focusing huge attention on many of the rules that lie at the heart of that fatigue. The in-depth Times piece looked at regulations impacting apple growers—including everything from water and labor rules to the "assortment of rules, guidances, standards and training requirements associated with ladders, including how to achieve proper angling and how to prevent falling when filling produce bags." The ladder issue was particularly apropos because of the name of an apple farm profiled in the story, Indian Ladder Farms in upstate New York. Many of the rules the article discusses are inane, costly, and unhelpful. Together, these rules, put in place by faceless acronyms—including the EPA, FDA, USDA, OSHA, and other state and federal agencies—can crush small apple growers, as I told the Times in the piece. "So many of the farmers I've spoken with tell me that stricter and stricter regulations have put many of their neighbors and friends out of business, and in doing so cost them their homes, land and livelihoods," I say in the Times piece. "For many farmers, rolling back regulations is the only way they can survive." Coincidentally, just days before the Times piece was published, President Donald Trump used remarks he made in the White House's Roosevelt Room to tout his purported deregulatory fervor and successes, touting his administration's first year as the "most far-reaching regulatory reform" efforts ever by a U.S. president. "We have decades of excess regulation to remove," Trump said. "To help launch the next phase of growth, prosperity and freedom, I am challenging my cabinet to find and remove every single outdated, unlawful and excessive regulation currently on the books." I have no doubt there are "decades of excess regulation to remove." There are. But I have no faith whatsoever either in the will or abilities of Trump or his appointees to carry out this rollback. Consider, for example, that Trump made a campaign pledge to kick the "FDA food police" out of Washington. His controversial executive order mandating that agencies revoke two regulations for every new one they seek to adopt could be used as a tool to accomplish just that. But like seemingly everything else Trump, his pledges and orders resemble little more than some sort of chintzy window dressing. FDA commissioner Scott Gottlieb, appointed by Trump, appears not even to share the Trump administration's purported zeal to cut food regulations. As a Regulatory Affairs Professional Society post noted recently, the Trump administration "has yet to take a saw to its regulations, and FDA Commissioner Scott Gottlieb seemed to walk back Trump's pledge" to do so. The website Food Dive also described Gottlieb's position on food regulations as almost entirely nebulous. "It hasn't been easy to get a clear sense of where the new FDA director stands on many food safety and nutrition issues," it reported. There's good reason to be skeptical of the willingness of Gottlieb's FDA to cut food regulations. For example, he doubled down last fall on awful Obama administration menu-labeling rules, part of the Affordable Care Act, saying the FDA will act in part because Gottlieb is a "doctor" and "father." He's also continued the Obama administration's nannying pursuit of all things "Loko," going after the snortable chocolate Coco Loko with the same gusto Obama's FDA targeted the caffeinated alcohol beverage Four Loko. It's not just Trump's FDA that stinks. His USDA has also been lousy. The Trump administration rolled back Obama administration rules on USDA school lunches—so that the rules are different than they were recently but still awful like they were before that—with t[...]



Why Won't the FDA Let Me Shove Chocolate Up My Nose?

Wed, 13 Dec 2017 12:15:00 -0500

The Food and Drug Administration (FDA) is going after a company that makes chocolate you can snort like snuff. The FDA has sent a warning letter to the makers of Coco Loko, a snortable powder made from cacao, about how they were marketing and labeling their products. Part of the complaint is stupid nanny-state nonsense. The makers of Coco Loko deliberately market themselves as an alternative to prohibited street drugs. In its complaint, the FDA absurdly complains that marketing Coco Loko as an alternative to drugs encourages the use of illegal drugs: "As a physician and a parent, I'm deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors. Encouraging the use of snortable chocolate as an alternative to illegal street drugs is not acceptable—there are very real consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse,"' said FDA Commissioner Scott Gottlieb, M.D. "At a time where drug addiction is threatening the fabric of American society, we must take action when we see efforts that may further fuel illicit drug abuse. We'll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients." The FDA also claims that using Coco Loko can trigger vocal cord spasms and exacerbate asthma. And it notes that the product includes taurine and guarana—ingredients common to energy drinks—that have not been evaluated for intranasal consumption. The FDA further warns that another product by the company—Legal Lean Syrup, a grape-flavored drink with herbal supplements—also contains a drug ingredient, doxylamine, that is not declared on labeling. That's a little bit more of a serious concern, as that drug is an ingredient in over-the-counter sleep aids and consumers might want to know that. Finally, the FDA objects to either product being sold as "dietary supplements." It looks like, in the end, the only thing the FDA isn't concerned about is people snorting chocolate. The FDA's response to Coco Loko's manufacturer, Arco Globus Trading, isn't as severe as it could have been, but that's because this hasn't reached the "enforcement" stage yet. The FDA is giving the company 15 days to explain how it's going fix all these problems. It isn't specifically telling the company that these products themselves are illegal...yet. Nevertheless, the company has shut down its shop on the web, so you cannot buy the stuff online anymore. That will no doubt please fearmongering nannies like Sen. Chuck Schumer (D–N.Y.), who started screaming over the summer that the FDA needs to do something about Coco Loco. Like Gottlieb, Schumer leaned heavily on the complaint that the product was "easily accessible" to minors. As I noted at the time, a container with 10 doses was selling for $20 dollars. That made it fairly expensive, and it seems to me that it's unlikely to actually appeal to children, particularly since they could just buy an energy drink or a candy bar. Or both! We'll have to wait and see if the company can able to handle all the labeling/marketing issues to the FDA's satisfaction. But I suspect the nannies have won this fight.[...]



The FDA Warms to Vaping

Fri, 01 Dec 2017 12:00:00 -0500

In July, the Food and Drug Administration (FDA) extended the deadline for e-cigarette manufacturers to seek regulatory approval of their products. On the face of it, the change was merely a four-year stay of execution. But the agency also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests the reprieve could turn into a commutation.

That would be good news for smokers who want to quit. For too long, American public health officials have been unreasonably hostile to e-cigarettes, which deliver nicotine in an aerosol that is far less hazardous than tobacco smoke and offers a closer simulation of the real thing than nicotine gum or patches do.

FDA Commissioner Scott Gottlieb seems to appreciate the public health potential of this innovation. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," he said in a press release. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts."

The FDA said "a key piece" of its new approach is "demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." The agency wants to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes."

Toward that end, the FDA is giving e-cigarette companies until August 8, 2022, to apply for permission to keep their products on the market under regulations published last year. The agency says it will use the extra time to seek additional public comment and develop clearer guidance for the industry.

The regulations require manufacturers of vaping equipment and e-liquids to demonstrate that approval of their products "would be appropriate for the protection of the public health." It is not clear what that means in practice, but the FDA projected that applications would cost hundreds of thousands of dollars per product, and many observers thought that was an underestimate. The burden was expected to drive most companies out of business.

If the FDA is serious about promoting "less harmful sources" of nicotine, it will develop transparent, straightforward, and practical criteria for approving current and new vaping products. Standing between smokers and products that can save their lives is surely not "appropriate for the protection of the public health."




Permissionless Biotech Crop and Livestock Innovation

Thu, 16 Nov 2017 17:46:00 -0500

Obama administration minions issued drafts of biotech crop and livestock regulations just two days before they left office last January. They were apparently motivated by their worry that genetically improved crops and livestock created using precise new genome-editing techniques like CRISPR would escape government oversight. There is good news. The USDA has now withdrawn these proposed regulations. The FDA should immediately follow suit and withdraw the scientifically indefensible regulatory proposals submitted by the Obama Administration. As I reported earlier: Treating each version of new improved livestock as a drug is really bad news for developers and consumers, since it takes years for a new drug to get through the FDA process at an average cost of more than $1 billion. Consider that it took the agency 20 years to approve the Aquabounty salmon that was genetically engineered simply to grow faster. The proposed USDA regulations were designed to change the way the agency approves genetically engineered plants and the draft FDA rules would subject genetically improved livestock to the same onerous process required to get the agency's permission to market new animal drugs. On the face of it, the precision of new genome-editing techniques would seem to call for less, rather than more regulation. The Obama administration proposed that breeders of gene-edited plants submit their new varieties to the USDA for pre-approval. Waiting on agency decisions would very likely slow down the process of developing new biotech crops even more. Under the Obama administration's proposed rules, the FDA would have required pre-approval of genetically improved livestock like Holstein dairy cows engineered to contain the same gene for hornlessness found naturally in Angus beef cattle. Since that gene in Angus cows harms no one, it wouldn't hurt anyone if it were in Holstein cows. So why should breeders have to beg FDA permission to sell hornless Holsteins? Why should breeders have to get regulatory permission at all to sell genetically engineered crop varieties or livestock? Breeders have for nearly 100 years been inducing genetic changes in plants by bathing them in caustic chemicals or blasting them with gamma rays to create hundreds of new crop varieties. The Mutant Variety Database run jointly by the Food and Agriculture Organization and the International Atomic Energy Agency lists more than 3,000 commercially available crop varieties created using mutagenesis. None of these mutated crop varieties required regulatory approval before their developers could introduce them into the marketplace. Why should crops created using vastly more precise biotech genome-editing need regulation? Animal welfare issues might arise in the cases of gene-edited livestock, but otherwise there is no scientific justification for regulating them as "new animal drugs." The FDA should speedily follow the USDA's salutary lead and withdraw the draft biotech regulations that the Obama administration left behind at that agency. Both agencies should step back and adopt the principle of permissionless innovation with respect to modern biotechnology. Mercatus Institute fellow Adam Thierer defines this as "the notion that experimentation with new technologies and business models should generally be permitted by default." He adds, "Unless a compelling case can be made that a new invention will bring serious harm to society, innovation should be allowed to continue unabated and problems, if they develop at all, can be addressed later." Since there is no such compelling case against advanced biotechnology, both agencies should radically reduce the amount of regulation that they currently impose on the development and deployment of modern biotech cr[...]



Ronald Bailey Talks Designer Kids, Paris Climate Agreement, and More on Federalist Radio

Fri, 10 Nov 2017 15:45:00 -0500

(image) At a new Federalist Radio podcast, host Ben Domenech and I discuss Trump's science policies, the ethics of designer babies, alcohol regulations, and more.

Does Trump withdrawing from the Paris Climate Accord have any tangible effects? "With regard to greenhouse gases in the United States, it was practically irrelevant," I claim. "The clean power plan is not what destroyed the coal industry. What destroyed the coal industry is fracking."

I point out that however onerous Obama's clean power plan would have been (its provisions had not yet been implemented, due to a Supreme Court injunction), the real enemy of coal is cheap fracked natural gas. No matter how much the president loves miners, most of those jobs are gone forever.

The U.S. power sector is likely to cut its carbon dioxide emissions by about 32 percent even without the clean power plan, given the price trends for natural gas and renewable energy technologies, as I reported last week. A new analysis from the Rhodium Group consultancy bolsters those earlier conclusions: "Our current projections put power sector CO2 emissions 27% to 35% below 2005 levels."

I also argue that the folks who want to ban the gene-editing kids are calling for something akin to state-imposed eugenics. Progressive Era eugenicists used government power, via nonconsensual sterilizations, to forcibly prevent parents from passing on traits deemed deleterious. Now, 21st century eugenicists want the government to require people to risk passing along genes that the parents think are deleterious. In both cases, the state is empowered to decide what sorts of people may be born.

Go here to listen to the discussion.




The FDA Will Finally Let You See Your Genetic Information

Tue, 07 Nov 2017 08:45:00 -0500

(image) Food and Drug Administration (FDA) head Scott Gottlieb is reeling in his agency's outrageous four-year ban on direct-to-consumer genetic testing.

Under the Obama administration, the FDA sent a letter to the genetic testing company 23andMe warning that the company was "marketing the 23andMe Saliva Collection Kit and Personal Genome Service...without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act." The letter noted that the company's tests had been providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response." But not anymore: The folks at 23andMe had little choice but to knuckle under to the agency's demands and stop testing new customers.

The company was eventually permitted to offer genetic test information on customers' ancestry and on genes associated with traits like the length of their toes. In early 2015, the agency allowed the company to provide users with results from a trait carrier test for Bloom Syndrome. Prior to the FDA's ban, the company's $99 genomic screening test package had included results from 53 trait carrier tests.

In April of this year, the FDA finally allowed the company to supply customers with genetic health risk information for 10 different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease, and hereditary thrombophilia (harmful blood clots). Before the ban, the company had been providing its users with some genetic insights with regard to all of those health risks and about 140 others.

Gottlieb's statement dramatically loosens his bureaucracy's stranglehold on direct-to-consumer genetic testing. After genetic health risk test manufacturers have passed through a one-time FDA review ensuring that they meet the agency's requirements for accuracy, reliability, and clinical relevance, any subsequent additional health risk tests will not need to undergo further review. "The floodgates for direct-to-consumer genetic tests are swinging wide open," declares the STAT science new service. Let's hope so.

For more background, see my 2011 Reason article on my own genetic testing experience here. Go to SNPedia here for even more information on my genetic flaws.