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Posts Tagged ‘FDA’
August 1st, 2019 at 4:29 pm
Drug Importation: An Inexplicably Bad New Proposal from the Trump Administration
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Yesterday, the Trump Administration through the Department of Health and Human Services (HHS) inexplicably introduced a proposal to begin drug importation from other countries.

Currently, Americans enjoy the safest medicine market in the entire world under the system monitored by the U.S. Food and Drug Administration (FDA).  According to FDA estimates, over 99% of drugs making their way into the U.S. via international mail failed to comply with its standards, and the United Nations World Health Organization estimates that fully 10% of all medicines worldwide are actually counterfeit.  That’s an enormous and unacceptable threat.

It’s therefore no surprise that a bipartisan array of experts and officials, including Trump Administration officials, have long panned the drug importation idea.  Just last year, for instance, HHS Secretary Alex Azar labeled drug importation a “gimmick,” emphasizing that, “the last thing we need is open borders for unsafe drugs.”  Recent FDA Commissioner similarly lambasted the idea and detailed the numerous threats that it entails.  A collection of FDA Commissioners spanning the years 2002 through 2016 went so far as to write an open letter to Congress in 2017, explaining how drug importation, “could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard or counterfeit drugs.”

Safety concerns, however, aren’t the only problem with the drug importation idea.  The Congressional Budget Office (CBO) has studied the issue and concluded that drug importation would have little to no impact on actually lowering prices.  Former FDA Commissioner Gottleib concurred that the plan “would have added so much cost to the imported drugs; they wouldn’t be much cheaper than drugs sold inside our closed American system.”  Part of the problem, according to a Canadian Pharmacists Association (CPhA) statement released just yesterday, is that Canada’s market couldn’t handle the sudden onslaught of American demand, and importation would crash their market on which the U.S. drug importation plan would rely.

Additionally, as we at CFIF have long emphasized, importing other nations’ pharmaceutical policies and pricing would reduce drug innovation and availability to American consumers.  Even highly developed nations enjoy far fewer new life-saving and life-improving pharmaceuticals than the U.S., which should trigger alarm for every American.

This constitutes a rare unforced error, as drug importation violates free market principles, in addition to the fact that imported drugs meet neither safety nor dependability standards.

How else can we be certain that this is a terrible idea?  Socialist Senator Bernie Sanders (D – Vermont) advocates it.  That says all we need to know.

 

March 28th, 2014 at 7:14 pm
The Party of Science Goes Full Luddite
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From The Hill:

The Food and Drug Administration isn’t ready to embrace mandatory labeling regulations for foods made with genetically engineered ingredients, despite an aggressive push from lawmakers and advocates who cite health concerns.

Testifying before a House panel, FDA Commissioner Margaret Hamburg told lawmakers this week that the agency remains comfortable with a 1992 policy decision concluding that food made with genetically modified organisms — or GMOs — is not materially different from other products.

“We have not seen evidence of safety risks associated with genetically modified foods,” Hamburg said during a House Appropriations Committee hearing to assess the FDA’s 2015 budget request.

She said the FDA is working on fresh guidance backing a voluntary system for GMO labeling, an approach critics regard as insufficient.

Rep. Nita Lowey (D-N.Y.) criticized the FDA’s unwillingness to impose mandatory labeling requirements, saying the action is the least the government can do to give consumers more information about the food on their dinner table.

“It’s beyond me that we can’t have accurate labeling,” Lowey told Hamburg at the hearing. “The labeling can’t hurt anybody but it’s possible that the lack of adequate labeling could, of course.”

Actually, neither of those statements are true. The labels could hurt people and the lack of labeling won’t.

First let’s get some basics out of the way. What qualifies as a “genetically modified organism”? Have a purebred dog in your house? That’s one. A rose bush in your garden? Yep, that too. In essence, any living being that has been bred for certain traits is a genetically modified organism. What the critics are upset with are industrial processes by which companies can cultivate these traits in the lab instead of breeding for them over the course of generations.

So, is there a reason to be concerned? Over to the Competitive Enterprise Institute’s Gregory Conko, writing in the Washington Examiner earlier this week:

The primary thing that makes genetic engineering unique is the power and precision it gives us to make those changes and then test for safety afterward. It has also given us food that is both safer for our families and better for the environment. Plants with a built-in resistance to chewing insects, for example, have allowed farmers to use millions of gallons less pesticide every year.

Dozens of the world’s most prestigious scientific bodies, including the National Academies of Science, the American Medical Association and the World Health Organization, have studied genetic engineering for more than 30 years and concluded that such foods are at least as safe as, and often safer than, conventionally bred ones.

The other thing that makes genetically modified plants different is they are subject to intense scrutiny by three different regulatory agencies in the U.S. alone. It takes an average of five to 10 years to develop and test a crop for consumer and environmental safety. This is followed by an additional two to four years of review by the Food and Drug Administration, Department of Agriculture and Environmental Protection Agency. And because most American farmers will not plant genetically modified crops they cannot export to global markets in Europe, Asia and South America, the wait is even longer in order to secure approval overseas.

The regulatory costs alone for testing and getting approval for a genetically modified plant variety average more than $35 million. By the time a new crop makes it to market, its safety has been confirmed by regulators in dozens of countries.

In 30 years of testing and commercial use in more than two dozen countries, genetically modified foods have caused not a single sniffle, sneeze or bellyache. This outstanding safety record is why the FDA does not require blanket labeling of such foods. It does, however, require labeling any time a food differs from its conventional counterpart in a meaningful way – such as a reduction in nutrients, the introduction of an allergen, or even a change in taste or smell.

The science here is overwhelming — and has a decades-long track record. That’s part of what makes the labeling idea such a bad one. Proponents often brush the evidence aside and claim that, even if the produce is safe, consumers should know what’s in their food (though, in many cases, what’s in it is no different with GMOs than organics). But that’s not cost-free. There’s the price, of course, of actually producing the labeling, but the bigger potential cost is the loss of business that would occur if GMO labeling became pervasive.

The point of labeling as a tool of regulation is to increase consumer knowledge. In this area, however, it’s likely that labeling would only fuel ignorance. The public is already poorly informed about GMOs. Mandating they be labeled — which gives the appearance of a warning — would only fuel fears that have no basis in science.

Those who care the most about GMOs are those who are already eating organic foods — foods, it should be noted, that go out of their way to market themselves as an alternative to GMOs. In other words, the market has already solved their problem. There’s no compelling reason — as a matter of science or policy — for them to be allowed to brand the GMOs that feed hundreds of millions of Americans with a scarlet letter just because of their scientific illiteracy.

March 20th, 2014 at 8:49 pm
New Food Labels: A $2 Billion Exercise in Irrelevancy
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Troy Senik, CFIF Senior Fellow, former speechwriter for George W. Bush and senior editor of Ricochet, discusses First Lady Michelle Obama’s push for new FDA nutritional labeling guidelines and the lessons learned from California’s regime of high taxes, oppressive regulation and rampant litigation.

Listen to the interview here.

February 28th, 2014 at 2:37 pm
Michelle Obama: New Food Labels Will Help Counteract the Fact That America’s Moms are Morons
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As a veteran of a speechwriting shop or two, I’m amazed that no one in First Lady Michelle Obama’s office thought to reel in the remarks that she made yesterday about the new FDA nutritional labeling guidelines that I blogged about yesterday. Here’s how the First Lady described the hellish odyssey of a mother in the supermarket under the current regime:

So there you stood, alone in some aisle in a store, the clock ticking away at the precious little time remaining to complete your weekly grocery shopping, and all you could do was scratch your head, confused and bewildered, and wonder, is there too much sugar in this product? Is 50 percent of the daily allowance of riboflavin a good thing or a bad thing? And how on Earth could this teeny little package contain five whole servings?

This stream of questions and worries running through your head when all you really wanted to know was, should I be eating this or not? Is this good for my kids or not? And if it is healthy, how much of it should I be eating? But unless you had a thesaurus, a calculator, a microscope, or a degree in nutrition, you were out of luck. So you felt defeated, and you just gave up and went back to buying the same stuff you always buy.

I’m not sure who these mothers are who find themselves overmatched by the grocery store, but it seems to me they probably need more help than just better labels on food. For the rest of us — all of whom seem capable of acquiring foodstuffs without an epistemic shutdown — this remains a $2 billion exercise in irrelevancy.

February 27th, 2014 at 7:09 pm
Obama Administration Forcing Food Companies to Spend $2 Billion to Change Fonts
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Following on Ashton’s post below, there’s yet another Obama Administration initiative that will reach deep into the pockets of the food industry.

As Politico notes, the FDA is overhauling the labeling requirements for nutritional information on consumer products. The new labeling requirements will more conspicuously display calorie counts, change the definitions of serving sizes, and mandate the description of added sugars. Unsuprisingly, this push is being spearheaded by the First Lady’s office (which invites the question of who empowered Mrs. Obama to do anything in the lawmaking department).

There’s certainly some limited utility to this nutritional information, though I imagine it probably would have emerged (albeit perhaps in a slower fashion) from market demand as Americans became increasingly diet conscious. That said, these changes are incredibly minor. Here, courtesy of Politico, is what the current labels look like by comparison with the new ones:

Current Label

Current Label

Proposed Label

Proposed Label

Now, you may be thinking “What’s the harm?” And that’d be a reasonable response if this was a cost-free exercise. According to the FDA, however the cost to the food industry to make this change will run around $2 billion. That, by the way, is enough to finance about 150,000 lap band surgeries.

It says something remarkable about the Obama Administration’s failure to engage in even the most basic cost/benefit analysis that that would be a less crazy way to tackle this supposed problem.

February 26th, 2014 at 5:29 pm
ObamaCare Menu Regulations Could Decrease Food Options

“Tucked deep in the Affordable Care Act is language requiring all restaurants with at least 20 locations to list nutritional information alongside each and every item on the menu,” writes Peter Doocy at Fox News.

The purpose is to inform customers about the nutritional value of a menu item before ordering.

This regulation hits made-to-order eateries particularly hard, since in practice the restaurant would have to provide customers with things like calorie counts on-the-fly – a nearly impossible task for places like Domino’s where up to “34 million different pizza combinations [are] available at the chain, when all crusts and cheeses and toppings are factored in.”

To make matters worse, the cost of compliance will fall on franchisees; i.e., the small business owners most at risk under the new regulation.

Domino’s and other groups are pushing for a solution that would deem restaurant owners compliant if they provide the nutritional information online or through an app.

But if that fails, it’s easy to see eateries cutting back on menu options and clamping down on substitutions. “Have-it-your-way” may soon become “Talk to the FDA.”

If the proposed nutritional rule goes into effect as-is, Americans can add food to the growing number of health-related choices – including doctors, hospitals and insurance plans – that are being reduced thanks to Obamacare.

November 20th, 2013 at 1:47 pm
Food Police Will Soon Hit Businesses with Pointless Regulations

A. Barton Hinkle, a Richmond Times-Dispatch columnist and Reason magazine contributor, wrote a fascinating and chilling column this week about the Food and Drug Administration expensive and burdensome new menu labeling scheme.

The regulations will “dictate the disclosure of calorie counts for foods sold in restaurants, grocery stores, delis, bakeries, coffee shops, and even gas stations,” according to Hinkle. And those businesses will pay a hefty price to comply with the policy. The federal government figures the rules will “cost more than $1 billion and require more than 14.5 million hours of labor to meet.”

The calorie posting regulations, which are expected to go into effect any day, have been debated for three years. Why? Because it’s confusing as hell to try to figure out how to force business owners to post the calorie count for custom made food orders.

Hinkle writes:

Consider, for example, pizza: The legislative director for Domino’s says ‘there are 34 million pizza combinations. We’ve done the math.’ Listing the calorie content for each possible variation would require a very large sign indeed.

Yet only one Domino’s customer out of 10 visits a Domino’s location. The rest order over the phone or online. So shouldn’t posting the caloric content on the company website suffice? It should, but it will not: The FDA’s proposed standards require actual signs, at every location.

While the regulations are bad news for big companies like Domino’s, at least they can make the calculations once and send those numbers to every location in their chain. It’s the small mom and pop pizza and sub shops, diners and other restaurants that face the worst burden. After all, small businesses don’t have the technology, money or time available to figure out the number of calories contained in a sandwich or a stew with hundreds of possible ingredient combinations.

The goal of these ridiculous federal calorie count regulations (which are actually a tax on businesses’ time and money) is, of course, to encourage people to consume fewer calories.

But menu labelling fails to reduce calorie intake. “Putting calorie labels on menus really has little or no effect on people’s ordering behavior at all,” according to Julie Downs of Carnegie Mellon who co-authored a study published last week in the American Journal of Public Health. “No matter how much calorie information is on the menu list, people still choose the food they like, not what’s supposed to be healthier.”

So, to recap, the government will soon hand down regulations that will be impossible to fully meet, will cost businesses considerable amounts of time and money, and will do nothing at all to benefit Americans.

Perfect. Just what this country needs.

April 20th, 2010 at 12:04 pm
Praising the Salt Institute

Thank heaven for the Salt Institute!  Surely the Framers of the First Amendment and America’s first sociologist, Alexis de Tocqueville, would appreciate collections of individuals banding together to inform the public – and the government – of the benefits of salt.  With today’s headlines proclaiming an FDA crackdown on sodium in food, now is the time to read about salt, its uses and benefits and the current issues in focus.

True, the assault on individual freedom and responsibility by the Obama Administration is startling, as evidenced by this quote from one of its friends in academe:

Most salt eaten by Americans — 77 percent — comes from processed foods, making it difficult for consumers to limit salt to healthy levels, experts say.

“We can’t just rely on the individual to do something,” said Cheryl Anderson, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health who served on the Institute of Medicine committee. “Food manufacturers have to reduce the amount of sodium in foods.”

Of course what she really means is making food manufacturers reduce the amount of sodium in foods by federal fiat.  This kind of bureaucratic paternalism will only be made easier with implementation of ObamaCare.  But as long as there are industries willing to energetically (and stylishly) present consumers and policy makers with resources from organizations like the Salt Institute, the Republic – and sanity – stands a chance.