When The Government Overrides The Free Market

On Wednesday The Wall Street Journal posted an article about the current controversy about the cost of an EpiPen. Anyone who understands free market economics has been scratching their head trying to figure out why there was no competition to manufacture this product (and thus a more reasonable price). Well, The Wall Street Journal article provides an explanation. For the moment, I am going to overlook the fact that the company involved made a large donation to the Clinton Foundation and that the person in charge of the company is the daughter of Democratic Senator Joe Manchin.

The article at The Wall Street Journal explains:

In a statement, the Democrat (Hillary Clinton) assailed the “outrageous” cost of EpiPen, an emergency treatment for allergic reactions known as anaphylaxis, and she demanded that drug maker Mylan “immediately reduce the price.” Federal and Senate investigations are pending into these spring-loaded syringes filled with epinephrine (adrenaline) used primarily by children with life-threatening sensitivities to food or insect stings.

Mylan has raised the price of EpiPen in semiannual 10% to 15% tranches so that a two-pack that cost about $100 in 2008 now runs $500 or more after insurance discounts and coupons. Outrage seems to be peaking now because more families are exposed to drug prices directly though insurance deductibles and co-pays, plus the political class has discovered another easy corporate villain.

Still, the steady Mylan rise is hard to read as anything other than inevitable when a billion-dollar market is cornered by one supplier. Epinephrine is a basic and super-cheap medicine, and the EpiPen auto-injector device has been around since the 1970s.

Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.

Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.

But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.

The article concludes:

Mrs. Clinton claims the EpiPen price hikes show the need for price controls, and she says she’ll require drug makers to “prove that any additional costs are linked to additional patient benefits and better value.” Somebody in Congress should require the FDA to justify how its delays are advancing the same goals.

Price controls are not the answer–a government agency that cannot be corrupted by special interests is the answer. The FDA has been interfering with the free market, and the price of the EpiPen is exhibit A in the case against the FDA. I am all for safe drugs and clinical trials, but I am tired of federal agencies being used to pick winners and losers.

The Mess In Washington And Some Suggested Solutions

Today’s Washington Examiner posted an article about the eight worst federal agencies in Washington and how they could be fixed.

Here are some of the highlights. The article begins with the Department of Education. It has a 2016 budget of $79 billion. About 6 percent (250) of its employees are considered essential. It has existed for 36 years.

The article states:

McCluskey (Neal McCluskey, who directs the Center for Educational Freedom at the libertarian Cato Institute) said only two Department of Education activities can be justified: the Office for Civil Rights, to enforce the 14th Amendment, and Impact Aid, which gives federal funds to school districts that are burdened by nearby federal installations such as military bases or large science labs. Even then, the department doesn’t perform those two activities particularly well, McCluskey said, but at least they’re justifiable.

In the ideal world, McCluskey would simply get rid of the department. “What the federal government does in education, largely through the Department of Education, is unconstitutional. As important, we don’t have evidence it’s really helping. So why should it continue to do any of this?”

The next department the article lists is the Environmental Protection Agency (EPA). The EPA has a 2016 budget of $8.14. About 7 percent (1072) of its employees are considered essential. It began operating in December 1970.

The article reports:

Ozone rules, the EPA’s new regulations for smog, also are a captivating force for lawyers looking to sue the agency. Greens are suing the agency because the regulations made law last year were not strict enough. Hailed as the most expensive regulations in history, industry is suing because they argue they are too strict. As a twist, industry groups have come to the EPA’s aid in the lawsuit by the greens.

Tom Pyle, director of the conservative American Energy Alliance, says in addition to the EPA’s far-reaching regulations that need to be reined in, “the whole agency needs to be reorganized.”

For example, his group has proposed a host of streamlining proposals in recent years targeting the National Environmental Policy Act review process, known as NEPA.

The NEPA review process has become a key target for critics who see it as an overly burdensome and duplicative process for permitting energy and infrastructure projects.

Another agency the article lists that are in need of reform is the Department of Health and Human Services. Payments to Medicare and Medicaid providers are not carefully scrutinized and fraud is a problem. Another issue in the Department is the Food and Drug Administration’s lack of speed in bringing new drugs to the market.

Other agencies listed are the Internal Revenue Service, Office of Personnel Management, the Secret Service, the State Department, and the Department of Veteran’s Affairs.

Please follow the link to the article to read the details in each department. We need someone in Washington who is not afraid to upset the status quo.

More Laws Not Written By Congress

Yesterday’s Washington Times reported that the Health and Human Services Administration has rewritten the rules in ObamaCare regarding birth control.

The article reports:

The Obama administration on Monday ordered all insurers to provide IUDs, the contraceptive patch and other birth control free of out-of-pocket charge to all women, thereby rewriting the rules after reports that some insurance carriers were refusing to cover all types of contraceptives.

Insurers must now cover at least one brand of contraception in each of 18 different methods outlined by the Food and Drug Administration, such as one type of oral contraceptive pill, one version of the emergency contraceptive morning-after pill and, notably, the vaginal ring, which some women could not get before without paying out of pocket.

Please follow the link above to read the entire article, but I am only going to focus on two aspects of the law. First of all–the Obama administration ordered all insurers. Insurers are asked to comply with a law that was never even considered in Congress. How does the implementation of this law represent anything the voters had any say in? Secondly, in what way is anyone in charge of implementing this law accountable to the voters? Has the government completely taken over the health insurance industry–telling them what they can cover and what they can’t cover?

The article further reports:

The Supreme Court last year ruled closely held corporations do not have to insure types of birth control that violate their moral beliefs, and the Obama administration is expected to update its rules soon.

Religious nonprofits, meanwhile, are still pursuing their cases through the courts, arguing that the “accommodation” the administration designed for them still leaves them complicit in contraceptive coverage.

America was established as a representative republic–our public officials are supposed to represent us and be accountable to us. ObamaCare is an example of what happens when a political class that is deaf to the wishes of Americans ignores the law. Meanwhile, members of Congress committed fraud to make sure that they and their staff were exempt from ObamaCare (rightwinggranny.com). It is time to reign in Washington and get back to government by the people.

 

Facts Versus Spin

We have all heard the whining and moaning about the Supreme Court decision on Hobby Lobby. Some of the media has painted a picture of Hobby Lobby that makes you wonder why anyone would work there. As usual, the picture the media has painted has little to do with the reality of the situation.

On Monday, The Corner at National Review posted an article citing actual facts about Hobby Lobby and the benefits it provides for its employees.

The article includes some of the comments the political left has made about the decision:

“This is going to turn the dial back,” Representative Debbie Wasserman Schultz warned on MSNBC. The Democratic party’s national chairwoman added: “Republicans want to do everything they can to have the long hand of government, and now the long hand of business, reach into a woman’s body and make health care decisions for her.”

“Today’s Supreme Court decision unfortunately jeopardizes basic healthcare coverage and access to contraception for a countless number of women,” said Democratic senator Jeanne Shaheen of New Hampshire.

Consequently, Senate Democratic leader Harry Reid said that his party now must “fight to preserve women’s access to contraceptive coverage.”

The article also includes some facts about Hobby Lobby:

Imagine that a woman starts work at Hobby Lobby tomorrow morning — July 1. She joins Hobby Lobby’s health care plan. It includes access, copay-free, to the following categories of FDA-approved birth-control:

  1. Male condoms
  2. Female condoms
  3. Diaphragms with spermicide
  4. Sponges with spermicide
  5. Cervical caps with spermicide
  6. Spermicide alone
  7. Birth-control pills with estrogen and progestin (“Combined Pill)
  8. Birth-control pills with progestin alone (“The Mini Pill)
  9. Birth control pills (extended/continuous use)
  10. Contraceptive patches
  11. Contraceptive rings
  12. Progestin injections
  13. Implantable rods
  14. Vasectomies
  15. Female sterilization surgeries
  16. Female sterilization implants

That really doesn’t sound like she is being denied healthcare. The article reminds us that Hobby Lobby offers medical coverage for 16 different kinds of birth control for its employees. The legal case was to exclude four methods that are seen to cause abortions. Again, there is no ban on employees using these four methods, but Hobby Lobby will not pay for them.

The article concludes:

Those who are screaming themselves hoarse after the Hobby Lobby decision would agree that Yeshiva need not serve unkosher food, and PETA need not include calf meat on its menu. Yes, somehow, Hobby Lobby is evil because it pays for 16 kinds of contraceptives, and expects its employees themselves to purchase four others that might kill human babies.

At its core, the Left’s moaning over Hobby Lobby is less about access to medicine and more about access to free stuff. 

I disagree with the writer’s conclusion. This is not about free stuff. It’s about convincing the low-information voter that there is a ‘war on women’ in conservative politics and that they need to vote for Democrat candidates. There are very few Americans who will do their homework and get the facts on this case–most will rely on news that quotes the type of statement quoted in the beginning of this article as fact. Would it be fair to say that Democrats regard women’s healthcare as the right to kill babies and that right must be protected?

It’s Not Really About Safety–It’s About Money

The Democrats have claimed that they want to make abortion safe and rare, but when it comes to supporting laws that make the procedure safer for women, they protest. The recent changes to abortion law in Texas are a good example of this.

Today the Daily Caller is reporting that the 5th U.S. Circuit Court of Appeals has overturned a lower court‘s decision that the changes in abortion laws in Texas were unconstitutional.

The article reports:

The higher court’s opinion upheld the requirements that a lower court deemed unconstitutional — specifically the mandate that abortionists have admitting privileges in nearby hospitals and that the administration of abortion-inducing drugs comply with Food and Drug Administration protocols.

The ruling had one caveat, that the requirements may not be enforced against abortionists who already applied for admitting privileges but are still waiting to be accepted by hospitals.

There is a risk in any medical procedure, including abortion. What the new law does is put provisions in place to help ensure a woman’s safety if something goes wrong during an abortion. There is no reason that Planned Parenthood and other pro-abortion groups should fight this as they have been claiming for years that their desire is to make abortions safe.

Abortion is about money, as the chart below from the Life Issues Institute illustrates (PPFA stands for the Planned Parenthood Federation of America):

planned parenthood profitUnfortunately, killing babies is big business.

 

Enhanced by Zemanta

Just Because It’s Legal Doesn’t Mean That It Is Safe

I will admit I really don’t know much about marijuana. I never smoked it, and the only contact I have ever had with a heavy marijuana user was a high school student who probably changed his life for the worse because of his marijuana use. It didn’t kill him, and he didn’t move on to other drugs, but it definitely impacted his life in a negative way. He was a very smart and gifted person who I don’t believe ever even approached his potential. Eventually he became a Christian and put the drugs behind him, but I am convinced that they took a heavy toll.

There are debatable risks of marijuana, and there are some risks that are not debatable. Newsbusters posted an article yesterday about the fact that less than 10 percent of legal marijuana is tested for substances that may be harmful. Some of the things that have been found when marijuana has been tested are molds, mildew, e-coli.

The article reports:

Reporter Barry Petersen talked to a biologist who tests pot. After asking her what could be in the newly legalized drug, Gennifer Murray responded, “We have found molds, mildew, e-coli.” She informed, “…What you can die from is contaminated cannabis.”According to Murray, less than ten percent of legalized marijuana in the state is tested.

Why are state legislators so anxious to put the people of their states at risk by legalizing marijuana? It really doesn’t make sense.

Enhanced by Zemanta

How Over-regulation Impacts Local Food Producers

I have lived in Southeastern Massachusetts for almost 35 years. When my husband and I and our daughters first moved here in October 1978, our neighbors told us we had to go see “The Big Apple.” Having New York City roots, we found this rather odd until we realized that The Big Apple was a local orchard and farm growing a variety of produce. Later, one of my fondest memories is driving the daughter of the owners (the Morse family) home one night and following their beautiful Christmas star through the snow to their house.

What I am trying to say is that The Big Apple is a local tradition. It has fresh cider, doughnuts, rides through the farm, apple picking, and a wonderful atmosphere. Unfortunately, government over-regulation may put The Big Apple out of business.

Today’s Attleboro Sun Chronicle posted a story about the impact of new government regulations on small family farms.

The article reports:

With new rules proposed by the U.S. Food and Drug Administration, The Big Apple would likely face expensive water testing requirements, paperwork and other changes covering not only its fields and orchards but its farm store, which washes fruit and serves up specialties like candy-coated apples.

“There’s a lot of paperwork,” Peg Morse said, adding that meeting the regulatory requirements could require as many as three or four additional full-time workers. The new rules would also require stepped-up water sampling and testing.

…The proposed new irrigation and water testing standards alone could cost the farm more than $20,000 per year, they say.

Currently, the Morses test water once a year. The new rules would require weekly testing of each and every water source the Morses use.

Since they draw from three irrigation ponds and two wells, John Morse sets the cost of testing, alone, at $400 per week.

There are lots of other changes, too, he says.

The farm will have to replace its wooden apple picking boxes with plastic ones, upgrade its machinery and change the way it applies fertilizer.

Proposed rules require nine months between the time manure is applied to a field and harvest time. With New England‘s short growing season, such a rule doesn’t make sense, Bonanno says.

The Morses say they’re worried about the new rules and how they would affect not only their business but their customers. All the added expenses would have to be paid by someone, and most likely would be passed on to the consumer.

“We might have to charge $12 for a bag of apples we now charge $6 for,” John said. “Who’s going to pay that?”

The article reminds us that if we drive the local farmers out of business, America will be forced to import more food from countries that do not have the strict agricultural standards that America has. Our attempt to increase food safety may in fact result in having a food supply that is less safe.

The bill involved in these changes is H.R. 933. The good news is that there is an amendment to the bill, H.AMDT.221 to H.R.1947, which requires a scientific and economic analysis of the FDA’s Food Safety and Modernization Act prior to final regulations being enforced with the focus of the analysis being on the impact of the bill on agricultural businesses of all sizes.

If the original bill is enforced, we will lose many sources of local produce throughout the country. In Southeastern Massachusetts, we will lose the experience of taking our children to a wonderful place where they can see apples sorted and drink fresh cider. That would also be a major loss.

Enhanced by Zemanta

Some Good News From The Medical Profession

The U.K. Express is reporting today that a drug has been discovered to slow the amount of brain damage suffered by people who have multiple sclerosis (MS).

The article reports:

Data presented at the European Committee for Treatment and Research in Multiple Sclerosis congress, showed the drug cut the risk of an attack by up to 60 per cent and brain shrinkage by 35 to 39 per cent.

Gavin Giovannoni, Professor of Neurology at Barts and the London NHS Trust, said the “important” research should bring patients improved quality of life.

Please follow the link above to the article to see the specifics. This is fantastic news for people suffering from MS.

Enhanced by Zemanta

The Health And Human Services War Against Religion Continues

A website called Catholic Online is reporting a new aspect of Obamacare. Under Obamacare, children 15 and over in the state of Oregon will now be able to undergo sterilization without parental consent. Just for the record, children younger than 18 need parental consent to get their ears pierced.

The article states:

The “Required Health Plan Coverage Guidelines” set forth by the U.S. Department of Health and Human Services states: “Non-grandfathered plans and issuers are required to provide coverage without cost-sharing consistent with these guidelines in the first plan year.that begins on or after August 1, 2012.All [FDA] approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.”

Under Oregon State Law, the state’s revised statutes (ORS) defines “informed consent” for 15-year-olds independently pursuing reproductive sterilization as being “(a) Based upon a full understanding of the nature and consequences of sterilization pursuant to information requirements set forth in ORS 436.225(1); (b) Given by an individual competent to make such a decision; and (c) Wholly voluntary and free from coercion, express or implied.”

I need to state here–I am not Catholic and I am not opposed to sterilization of an adult who makes that choice. That is not the point. What is happening here is that a major decision that will affect a child for the rest of his (or her) life is being made without parental input. That is just too much government for my taste.

 

Enhanced by Zemanta

Another Industry Suffering From Overregulation

The Washington Examiner posted an article today on the government-caused drug shortages America is experiencing. Yes, you read that right.

The article reports that prescription drug shortages tripled from 2005 to 2010 and reached record levels in 2011 as manufacturers ceased operations or ran into production problems.

The article reports:

Last year, nearly half of hospitals reported experiencing a drug shortage on a daily basis, according to a survey of 820 hospitals by the American Hospital Association. About 82 percent of hospitals said they delayed treatment because of a shortage, and 35 percent of hospitals said patients experienced “adverse outcomes.” The survey did not categorize those outcomes, a spokeswoman said.

So what is going on? The Federal Food and Drug Administration (FDA) has increased its enforcement efforts. The article explains:

…the FDA’s “zero tolerance” regime is forcing manufacturers to abide by rules that are rigid, inflexible and unforgiving. For example, a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

We elected this government. We are responsible. The only way to fix this is to unelect everyone who has worked toward bigger government and more regulation and elect people who want smaller government and less regulation. It’s up to us.

 

Enhanced by Zemanta

Hidden In The Small Print…

Big Government is reporting today on some aspects of ObamaCare that I don’t think any of us had considered. Your cell phone is about to become a medical device (yes, you read that right) and your own stem cells are drugs. Good grief!

The article reports:

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.

…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!…

We have entered the Twilight Zone. If you care to leave the zone, please vote Republican in November.

Enhanced by Zemanta

Tackiness Prevented

Jeff Jacoby at the Boston Globe posted an article today about the decision last week by US District Judge Richard Leon to block a Food And Drug Administration (FDA) rule that would require cigarette manufacturers to put graphic images on cigarette packs showing the dangers of smoking.

A few disclaimers here–I don’t smoke–never have–I hate the smell of cigarette smoke, but I don’t think smokers should be forced to stand in the freezing snow outside a restaurant to enjoy a cigarette. (However, they do need a separate section of the establishment with a separate ventilation system,)

However, required graphic images on cigarette packs is a bit much even for a non-smoker like me.

The article points out:

The FDA’s gruesome new labels are not designed to provide consumers with useful information about the hazards of smoking. After 45 years of mandatory Surgeon General’s warnings, every non-comatose American knows perfectly well that cigarettes are a noxious health risk. That’s why the share of Americans who smoke at least occasionally has fallen to an all-time low of 19.3 percent, or less than 1 in 5 — a far cry from the more than 42 percent who were smokers in 1965. No one, not even Big Tobacco, disputes Washington’s right to require cigarette makers to disclose pertinent facts about their product’s dangers. Those disclosures, it’s clear, have been effective.

The government has no power to require the cigarette companies to put graphic images on their cigarette packs. To me, the requirement that there be an anti-smoking warning is a stretch.

Enhanced by Zemanta

Unintended Consequences Of Changes In Food And Drug Administration Policies

The American Spectator reported today that there is a shortage of essential cancer drugs due to some changes in policy at the Food and Drug Administration (FDA).

The article reports:

The shortfall is the result of stricter FDA regulation, government price controls on already discounted but complex drugs, and policies that discourage the use of new medications. Companies, facing lower prices, tighter regulation and increasing government control over what drugs will be used and when, are exiting the U.S. market and investing in product development in China and India where, sadly, it is easier and cheaper to produce next-generation medicines.

As usual, government interference in the free marked is having a negative impact on the lives of Americans.

The article further points out::

Provenge, the first cancer vaccine, stalled at the FDA for years. Once approved, it faced 18 months of additional delay while the Obama administration figured out whether to pay for it. The gauntlet cancer patients face with Provenge is being extended to everyone waiting for a medical breakthrough under Obamacare. Before a medical innovation can be used or paid for, the government will now demand additional research demonstrating that a new product will be more effective and cheaper than existing technologies. Since most new products come from small start-ups with limited cash, such a requirement means life-saving innovations will not be available at all.

There will always be some risk associated with a new drug, but is it better to let people die than to take a reasonable risk?

This is the same government that decided that in order to save money, women under the age of fifty should not get mammograms. Since breast cancer can occur at any time and tends to be more aggressive in women in their thirties, this is the kind of decision that will result in women dying. I know a number of women who had breast cancer in their thirties and forties. They would never have discovered the cancer in time if the government policies of no mammograms until age fifty had been in effect.

Let the government do government things and the medical community do medical things. All Americans are negatively impacted when the government attempts to micromanage healthcare.

Enhanced by Zemanta