EDITORIAL: A regulatory drug shortage – Washington Times

EDITORIAL: A regulatory drug shortage – Washington Times.

FDA’s marketplace intervention endangers cancer patients

The last thing a sick person wants to hear is that ample supplies of a life-saving medicine have been replaced by a surplus of red tape. That’s precisely what’s happening nationwide, with 82 percent of hospitals reporting shortages so severe that treatment must be put on hold, according to the American Hospital Association. Since 2010, 210 drugs, many of them critical components of cancer treatment and anesthesia, have been at dangerously low stock levels.

On June 15, the House Oversight committee issued a report implicating the Food and Drug Administration (FDA) and a badly drafted law for the current state of affairs. Many of the hard-to-find drugs are now off-patent, produced as generics with very narrow profit margins. The Medicare Modernization Act changed the way manufacturers were reimbursed for older generic drugs, particularly when administered in a nonhospital setting. The price of three chemotherapy drugs, as the report details, fell 90 percent in the first year they went off-patent.

The price drops were steep enough that manufacturers began to give up. In a free market, the price for the drugs would rise until supply could meet demand. It didn’t happen here because the government plays such a major role in Medicare that the law effectively imposed price controls. Only a few big manufacturers who could exploit economies of scale and turn a modest profit on the low-margin generics continued making these medicines.

Even this would not be a problem under normal circumstances, but the FDA began getting more involved. In 2009, the FDA sent out 474 warning letters to manufacturers, 673 in 2010 and an astounding 1,720 in 2011. As the congressional report noted, there’s no evidence anyone has been injured from medication manufactured in the United States, but the federal busybodies forced four out of the five largest American injectable drug manufacturers to undertake remediation efforts. As a result, there was a 30 percent drop in drug-production capacity.

The FDA’s ham-fisted approach suspended entire facilities or major plant renovations instead of using targeted inspections. The agency didn’t consider the impact of its actions on the nation’s drug supply or on cancer patients. For the last two years, hospitals and doctors have been forced to make decisions about which patients get the drugs that are available, and which ones go without, or whether to substitute a drug that might not work as well.

In true bureaucratic fashion, the FDA is tackling the crisis it created by expanding its Office of Drug Shortage. The idea is to get information ahead of time about which drugs will be in short supply. This leaves in place the root cause of the problem: government intervention in the market. The supply of generics will not grow, and the concentration of the market will not decrease unless the production of these drugs becomes more profitable. That requires lifting the government-imposed cap on prices. There are enough big players on the other side, in the form of the group purchasing organization, to keep prices in check. The FDA needs to step back and try to do no further harm.

The Washington Times

ObamaCare Subjects Nearly Every Phone and Computer to Government Control – Tea Party Nation

Do Obamacare? About his job, not yours.

Do Obamacare? About his job, not yours. (Photo credit: go thunk yourself)

ObamaCare Subjects Nearly Every Phone and Computer to Government Control – Tea Party Nation.

Posted by Seton Motley

As we have been again reminded by the Barack Obama Administration’s Sandra Fluke-abortion-pill-and-birth-control assault on the First Amendment, we are staring down the barrel of the ObamaCare gun.  

Its 2014 full-on implementation will lead inexorably to more and more rescissions of our Constitutional rights, a downward spiral of poorer, slower medical attention, rationing thereof – and ultimately all of us herded into the government-only Communal Care Pit.

Our Overlords will slide ever-smaller bowls of health care meat into the Pit – keeping the very best bits for themselves, of course.  And watch while we 300+ million Americans fight for and over the ever-dwindling scraps.

This is the President Obama vision.  He deems it unfair that some are at the bottom – so there he will consign us all.  This is the Left’s definition of Equality – everyone having equal amounts of nothing.  

Save, of course, for Obama and the other Overlords.  They will still get the very best – while conscripting us to wallow in perpetual, poverty-riven misery.  

See: Union, Soviet.  Or Korea, North.  Or Cuba, Fidel.

But as we race towards this ObamaCare dystopia, technology is every day making individualized and ever better medicine more readily available to everyone. 

Which is why the Obama Administration is again targeting it for totalitarian control.  

—–

This is not just another assault on individual health care.  It is yet another attack on the entire Internet and technology free market Xanadu that exists – and has only just begun to develop.

See: Neutrality, Network.

The completely absurd Fluke-esque demand for birth control “freedom” – from charge – obfuscates and distracts from the dramatic, sweeping freedom losses that ObamaCare imposes.

On July 19, 2011, the Obama Food and Drug Administration (FDA) released Draft Guidance for Industry and Food and Drug Administration Staff ….  

I.e. our smartphone, tablet and computer apps. 

The Obama Administration – the most unilateral-power-grab Presidency in our nation’s history – is asserting that these mobile medical apps may pose “risks.”  And thusly should be regulated as medical devices.

The only “risks” posed by these individualized medical marvels – are to the Administration’s push to consign us all to the Communal Care Pit.  The more control we each have over our own health care, the less Communal control our Overlords have.  

And this obviously must be stopped.

—–

According to the Administration, the two dollar app that takes your blood pressure should be regulated like an MRI machine.  

(And does anyone doubt that one day in the not-too-distant future we’ll be able on these wondrous devices to self-MRI?)  

And because your phone has on it the two dollar blood pressure app – the Obama FDA asserts that they can thusly regulate your entire phone.  Because according to them that one app has turned your phone into a “medical device.”

Under the FDA’s expansive parameters, almost any device on which you do almost anything regarding your health – your smartphones, your tablets, your desktop and laptop computers – will be regulated.  

Did you use your smartphone/tablet/computer camera or microphone to monitor something health-related?  It just became an Obama FDA-regulated medical device.

Did you save your health care data on any smartphone/tablet/computer?  That too is now regulated.

Did you send an email containing any health care information to your doctor?  The device from which you sent said missive is too now regulated.

Think we’re exaggerating?  

Here’s the Obama FDA’s long litany of “Mobile Medical Apps.”  A virtually limitless expansion of regulatory authority over not just the:

 List of functionalities to illustrate types of mobile medical apps….

But also the:

Mobile medical apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions.

And the:

Mobile medical apps that allow the user to input patient-specific information and – using formulae or a processing algorithm - output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions.

In other words – almost any device on which you do almost anything regarding your health.

Still think we’re exaggerating? 

Obama’s FDA is concurrently asserting that the adult stem cells in your body are a “drug” – and that therefore your body is now government regulatory property.

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!…

Remember when the Left’s battle cry was “Get Your Hands Off My Body?”  

In the Age of Fluke, it is now “Let me get my hands on your wallet, so that others can cost-free get their hands on my body.”

The government has gone from protecting your life, liberty and property from others – to guaranteeing others access to your life, liberty and property.

The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within (a single) state….

Still think we’re exaggerating?

—–

The choice in November is yours.  

You can be snow-blinded by a corrupt, Fluke-ish “War on Woman” – where free-from-cost birth control is allegedly the greatest freedom problem facing our nation.

Or you can with your untrammeled sight view the gi-normous usurpations of our freedom in which President Obama and his Democrat cohorts have serially engaged.  

Perhaps most gi-normous of all being ObamaCare.  Under which the government is doing what government always does – expanding boundlessly the parameters of its authoritarian control.

Up to and including over nearly every computer device we own – and the very stem cells our bodies contain. 

Tell you what – I’ll co-opt the Left’s old mantra. I’ll pay for my birth control, and you Get Your Hands Off My Body – and my smartphones, tablets and computers.  

As freedom trade-offs go, that’s a pretty good one.

The FDA Kills – John Stossel – Townhall Conservative

Photograph of the Taxus drug-eluting stent, fr...

Image via Wikipedia

The FDA Kills – John Stossel – Townhall Conservative.

It would be nice if politicians and regulators left us alone. But they don’t. They always want to do more. Recently, there have been shortages of some medicines. Cancer patients can’t get drugs they need. Why not?

One reason is that a big drugmaker shut down for a year in part to meet Food and Drug Administration rules. The FDA makes it so expensive and difficult to sell drugs that there isn’t an eager pack of companies rushing to the fill the gap. The free market would provide that, but government intervention, such as low Medicare reimbursement, strangles it. So people suffer.

Does the FDA say it’s sorry for its part and back off? Of course not. Regulators almost never do that. In fact, the FDA wants more power.

It wants to regulate how your doctor uses his smartphone. I’m not kidding! The FDA wants the power to approve mobile medical apps that let doctors monitor patients’ vital signs over their phones. As one doctor put it, “Even though I’m away from the hospital, I can still look at … real-time wave form data just as if I were at the patient’s bedside.”

Sounds great. It makes doctors more efficient. But the FDA basically says, “No, you just can’t put something on your phone if it’s a medical device. What if it doesn’t work right? We have to approve it first.”

That caution makes sense to people. Our first instinct is to say, “I don’t want someone getting rich off a device that might not work right. It might kill me. I want the FDA to make sure everything is safe and effective.”

But lawyer Jonathan Emord says our instinct is wrong.

“It is wrong because these regulations are costly, burdensome, and they prevent essential medical apps from getting into the marketplace,” Emord said.

But an app might kill me.

Emord said that although many medical apps are available, there is “not a single complaint that someone has died or been seriously injured by a single one.”

But what’s the harm in running apps past the regulators?

“There is so much corruption at the Food and Drug Administration … so much anticompetitive bias.”

The FDA takes bribes?

“Almost,” Emord explained. “If you feather the right nest, you will do well for yourself after you leave. This is well known.”

This is known as “regulatory capture.” A regulator makes it tough for some company’s competitor and then gets a job with the first company when he leaves his government job.

There’s a big cost to the public when companies submit applications and then wait years for FDA approval.

“We’re losing time, precious time that lives are dependent upon,” Emord said. “MIM Software developed a simple mobile device that would combine MRI images, PET scans, CAT scans all together and produce a super image that was better for diagnosis … right on your phone. To get that through the agency, it took two and a half years and cost some hundreds of thousands of dollars. All the while it could have been in use, and ultimately it was approved.”

Lawyers and reporters encourage bureaucrats to move slowly. If something goes wrong, the media make a huge fuss about it, and the class-action parasites pounce. But when the FDA delays a device for years and people die, we don’t report that. We don’t even know who the victims are.

Useful HIV drugs were available in Europe for years before the FDA approved them for use here.

A doctor at the Cleveland Clinic invented a medical app that helped physicians calibrate the amount of radiation to give to women with breast cancer. The FDA demanded so much extra and expensive proof of its safety that he abandoned it.

The FDA’s caution leads many companies to just give up on potentially lifesaving ideas.

Yet I don’t hear companies complaining.

“If you raise your head above the parapet and you become vocal in your criticism, the FDA remembers like an elephant and will stamp you out of existence. They’ll punish you. It’s so much discretion in their hands. They sit like emperors reigning over this stuff.”

Obama’s Drug Shortage Demagoguery – Michelle Malkin – Townhall Conservative

Drug Enforcement Administration badge.

Obama’s Drug Shortage Demagoguery – Michelle Malkin – Townhall Conservative.

President Obama couldn’t wait to trample over the legislative process again. This week, he issued his 98th executive order on an irresistibly exploitatable policy issue: prescription drug shortages. Soon, “One a Day” won’t just be a multivitamin. It’ll be the rate of White House administrative fiats.

Federal officials darkly suggest that selfish industry “stockpiling” is endangering Americans’ lives. “If we find out that prices are being driven up because shortages are being made worse by manipulations of companies or distributors,” the White House further threatened, “agencies will be empowered to stop those practices. And the FDA and the Department of Justice will be investigating any kinds of abuses that would lead to drug shortages.”

As usual, the underlying reasons for these marketplace conditions are gobsmackingly complicated. As usual, a significant portion of the fault lies with the government — not evil corporate “abuses.” And as usual, Obama’s unilaterally imposed “solutions” promise to do more harm than good.

There’s no question that drug shortages exist and that they have been on the rise. According to the U.S. Food and Drug Administration, 246 drugs are now scarce. It’s a record. Why? I’ve rounded up just a few of the reasons:

— DEA rules. In some cases, manufacturers have been ensnared by federal Drug Enforcement Administration regulations. Take Adderall, the attention-deficit hyperactivity disorder medication. As ABC News reported earlier this year, Shire Pharmaceuticals makes Adderall “and is under contract to provide the generic form of the drug to Teva Pharmaceuticals and Impax Laboratories, which mass produce the generic.” According to Shire, their supplies have been hampered by DEA restrictions on the amphetamine-based medications, which are tightly monitored controlled substances.

— FDA rules. According to the American Society of Health-System Pharmacists and other professional organizations, “several drug shortages (e.g., concentrated morphine sulfate solution, levothyroxine injection) have been precipitated by actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative, which is designed to increase enforcement against drugs that lack FDA approval to be marketed in the United States.” These industry experts point to additional new drug manufacturing approval processes that are “lengthy and unpredictable, which limits their ability to develop reliable production schedules.”

— Manufacturing problems and generic drug status. Sterile injectables such as Propofol, a widely used anesthesia drug, are notoriously difficult to make. The timeline is long; interruptions in manufacturing one drug can affect multiple products. Sterile injectables can be contaminated easily. Several batches have been recalled in recent years because of dirty particulate matter found in vials.

Recall and liability headaches have led manufacturers to get out of the business. Moreover, as low-priced generic drugs, sterile injectables just aren’t as attractive to pharma companies already weathering tough economic times. When drugs go off patent, the prices decrease. The rest is elementary.

“If the costs associated with making a drug begin to outweigh the profits,” the New England Journal of Medicine explained, “companies may wish to discontinue production of the drug in favor of a newer, more profitable product. If the number of companies making an older drug decreases, and there is a delay or problem in manufacturing, shortages can and do occur.”

— Bush-era Medicare price controls and Obamacare price controls. Everyone from the free-market Wall Street Journal editorial board to renowned death panelist Ezekiel Emanuel agrees that low prices yield inevitable shortages. President Bush and Republicans imposed a 6 percent cap on cancer drug price increases that took effect six years ago. Health care analyst John Goodman adds that Obamacare exacerbated a separate federal price distortion, which requires drug companies to provide rebates to certain hospitals and clinics “of 23.1 percent for brand drugs; and 13 percent for generic drugs off of their average manufacturer’s price on qualifying outpatient drug use.”

Emanuel, the controversial former Obama health care guru, provided an unexpected shot in the Democrats’ market-bashing arm in a recent New York Times op-ed: “You don’t have to be a cynical capitalist to see that the long-term solution is to make the production of generic cancer drugs more profitable.”

But instead of a sober debate about the wildly divergent reasons for some of these shortfalls, Obama’s perpetual campaign machine gave us taxpayer-funded videos that yank the heartstrings and smear pharmaceutical companies. Instead of an honest assessment of the proposed government “fixes,” Washington bureaucrats are using patients as human shields to disguise new power grabs.

Unfortunately, the only cure for Team Obama’s overdose of toxic demagoguery lies at the ballot box. We can’t wait.

MILLER: Red-tape timeout – Washington Times

MILLER: Red-tape timeout – Washington Times.

Job creation requires moratorium on Obama regulations

President Obama stubbornly clings to the idea that adding government regulations will help the economy. Even the dire economic conditions won’t get in the way of his ideology.

On Tuesday, Mr. Obama dictated a suite of brand-new mandates for trucks and buses that will send shipping costs through the roof. Any day now, the Environmental Protection Agency (EPA) is expected to release new ozone rules that could cost the economy $1 trillion and destroy 7.3 million jobs, according to an estimate by the Manufacturers Alliance.

When it comes to putting people out of work, Mr. Obama is second to none. He took office with the unemployment rate at 7.8 percent. It’s now 9.1 percent.

Freshman Sen. Ron Johnson, Wisconsin Republican, has more experience in creating jobs than our community-organizer-in-chief. For 31 years, Mr. Johnson ran a plastic-sheet production company he started with his brother-in-law.

“The regulatory burden that we’ve been putting on businesses for decades has gone into hyperdrive during the Obama administration,” Mr. Johnson told The Washington Times in an interview. “It’s really gone into super-hyperdrive now that they have lost their filibusterproof majorities in Congress. The only way they can push their agenda now is by doing it through the regulatory agencies. I thought we need to call a time out. Stop the madness.”

Mr. Johnson introduced the Regulation Moratorium and Job Preservation Act, which would stop federal agencies from implementing any significant new regulatory actions – except for national security and national emergencies – until the unemployment rate drops below 7.7 percent. The legislation already has 19 GOP co-sponsors.

The EPA and its backdoor “cap-and-trade” rules are the primary target.

“I do not know why they are trying to regulate us back to the Stone Age, but that is really what they are trying to do,” Mr. Johnson explained. Democrats “want to see electricity rates skyrocket. How do you grow an economy with rising energy prices? They just don’t grasp the fact that in order to grow an economy, you need energy.”

The other problem with excess regulation is that it encourages industry to pack its bags looking for a friendlier business climate. A medical-device manufacturer in Wisconsin, for example, is waiting to get Food and Drug Administration approval for a device to help people with glaucoma.

“That business will go offshore,” Mr. Johnson said. “It is not a huge business, but the problem is that these regulations destroy businesses on a case-by-case basis; they destroy jobs on a worker-by-worker basis.”

Mr. Obama already has spent $4 trillion in borrowed money during his time in office, and his lavish “shovel-ready” schemes have failed to stimulate anything other than the length of the unemployment lines. Mr. Johnson’s alternative would let the real job creators – the private sector – take over. They’re the ones who know how to get the job done.

Emily Miller is a senior editor for the Opinion pages at The Washington Times.

Blog: Food Totalitarians on Parade – Part Deux – American Thinker

Blog: Food Totalitarians on Parade – Part Deux. – American Thinker.

Chuck Roger

Well that didn’t take long. Yesterday, in a post discussing a New York Times op-ed that called for heavy taxation on “unhealthy” foods, I asked, “How long before some starry-eyed but angry-faced Democrat proposes legislation to force ‘healthy food’ advertising?” Now The Daily Caller reports that food producers could face government regulations requiring “healthy” composition profiles for foods marketed to children two to seventeen years old.

If enacted, new regulatory criteria will reclassify many foods which the FDA presently considers healthy as off limits for advertising to children. In the present formulations, eighty-eight of the top 100 most-consumed foods will be considered ineligible for advertising. “Unhealthy” foods won’t be able to be marketed using in-store displays, TV, radio, the Internet, printed media, movie theater concessions, video games, and various other outlets.

A Kraft Foods official points out that while “food and beverage companies should market responsibly to kids,” the proposed advertising limitations are “so restrictive that foods like reduced fat peanut butter or two percent milk string cheese could not be advertised to children.” In other words, food totalitarians are behaving like totalitarians.

Companies that market irresponsibly pay the price at the hands of consumers after word of product misrepresentations gets around. The marketplace determines product success rates–an utterly reliable, time-tested principle.

In yesterday’s post, I wondered, with “[s]ugar, salt, trans-fats, [and] fats in general” coming “under assault by sanctimonious busybodies seeking to dictate ‘healthy’ eating to everyone,” how long would it be until Americans see government-mandated “healthy food” advertising?

We have our answer. Watchdogs at the Food and Drug Administration, the Federal Trade Commission, the Centers for Disease Control and Prevention, and the United States Department of Agriculture have joined together to force parents to solve childhood obesity. Again from the Daily Caller:

The government proposal would require that foods marketed to children and teens come from one of the following food groups: fruit, vegetable, whole grain, fat-free or low-fat milk products, fish, extra lean meat or poultry, eggs, nuts and seeds, or beans. They must also contain no more than trace amounts of saturated fat, trans fat, added sugars and sodium.

Federal food totalitarians are ignoring the actual causes of childhood obesity. Unscrupulous advertising doesn’t even make the long list of cause candidates. Besides hardwired eating urges, there is also at least one strong contributing factor to childhood obesity: parental behavior.

Does any clear thinker honestly believe that advertising restrictions and federally-dictated food composition changes will transform parents into automatons who feed kids bogusly-hyped, reformulated food thingies? Most parents look for fast, easy, desirable, filling foods to satisfy kids’ hunger pangs. “Improved,” “healthier,” yucky, lightweight fare doesn’t make it onto most parents’ shopping lists for good reason: tasteless, unsatisfying concoctions stay in the pantry until said concoctions could be used to hammer in nails; bland, unsubstantial plant materials sit in the fridge until pungent, multicolored growths appear.

So here I go again, making another ridiculous but increasingly likely prediction. Will we next see legislation that calls for kids to be taken from parents who provide the “wrong” foods, those kids then remanded over to the more responsible, more caring state? Remember, many observers scoffed at the suggestion that, in America, Americans would be ordered by the state to buy medical insurance coverage.

 

A writer, physicist, former high tech executive, and Cajun, Chuck Rogér invites you to sign up to receive his “Clear Thinking” blog posts by email at http://www.chuckroger.com/. Contact Chuck at swampcactus@chuckroger.com.

 

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