Tuesday, August 20, 2013

The FDA’s war on compounding pharmacies

Compounding pharmacies are in the crosshairs of the Food and Drug Administration. Subjecting this time-honored tradition to more government regulation will not make it safer. In fact, it will increase cost of the healthcare for folks who use compounded medications, further restrict our health freedom, and diminish competition with the big pharmaceutical companies.

Compounding pharmacies make custom medications for patients with unique needs, such as a different dosage, or method of use, or if a patient is allergic to the fillers in a medication. Like all pharmacies, compounding pharmacies are regulated by their respective states.

However, since the FDA regulates the manufacturing of drugs, the US Senate is proposing legislation that would put compounding pharmacies under the purview of the FDA.
The bill, S. 959, would subject mom and pop compounding pharmacies to many of the same regulations as the big drug manufacturers. If it were to pass, the result would be many small mom-and-pop businesses shutting their doors permanently.

The Senate’s action is in response to a deadly outbreak of fungal meningitis caused by contaminated medicine distributed by the New England Compounding Center (NECC), a large and now defunct Massachusetts-based pharmacy.

The culprit behind the outbreak was a high-dose injectable steroid used to treat inflammation and pain associated with conditions like herniated discs and certain types of arthritis. Most compounding pharmacies do not produce this type of medication. In fact, it is alleged that, in this instance, NECC was repacking and selling the existing medication — a crime in itself — and was not actually engaged in the practice of compounding.

Incidentally, the FDA and local authorities were aware of dubious practices at NECC as early as 2006.

The reason doctors turned to the NECC’s more expensive product instead of cheaper generic versions is that there was a national shortage of these drugs, due to increased FDA inspections of drug factories. While the inspections turned up few actual health threats, they caused a disruption in the supply chain and many healthcare providers had no choice but to use more expensive (and in the case of NECC, less reputable) alternatives.
Thus, it appears that the FDA bears some culpability for the meningitis outbreak.
In the free market, failure is punished. When it comes to government, on the other hand, instead of the guilty agency being punished for incompetence, it is usually rewarded with more power and authority, and a bigger budget.

That is exactly what’s happening here.

The FDA has long held a bias against alternative medicine. For instance, it is illegal for manufacturers to claim that vitamins cure disease. Only drugs can make that claim. So we have are left with the curious situation in which the FDA denies the medicinal benefits of vitamins, even though it is a scientific fact that some disorders, such as scurvy, are caused by vitamin deficiency!

In another example, recent studies show that garlic and its primary active ingredient allicin can significantly lower blood pressure. While garlic has none of the side effects of anti-hypertensive drugs, garlic producers are prohibited from promoting this specific benefit of the plant.
Unfortunately, the FDA is a poster child for “regulatory capture,” which occurs when regulatory agencies become dominated by the very industries they were created to regulate.

Big Pharma uses the FDA to constrain competition from the world of alternative medicine, thus protecting their own profits in the process. Naturally occurring inexpensive treatments such as garlic and vitamins simply do not provide the profit margin that synthetic compounds do. No wonder the FDA prohibits even substantiated claims about their medicinal properties.

Small business owners understand full well how large corporations work in conjunction with the federal government to squeeze out the little guy — to eliminate the competition through burdensome regulation. The same is true when it comes to pharmaceuticals and the FDA.

Government consumer safety regulators often do more harm than good. There is a myth that without the government to protect us, we would live in a world of poisoned food, tainted medication, and exploding toasters.

In fact, the opposite is true. Companies like Underwriters Laboratories, Consumer Reports, and private certification agencies illustrate that the market is completely capable of providing for consumer safety.

In addition, government regulatory agencies undermine the practice of “buyer beware.” Consumers often view all products as the same, and safe, because the government regulates them. Whether it’s food, healthcare, or finance and banking, government regulation subverts personal responsibility and encourages dependency.

While there are certainly some unethical and even criminal businesspeople, the vast majority of businesses recognize that the path to success lies in providing safe, quality products that consumers like and trust. It is thanks to them, not government regulators, that we have a safer, higher quality of life than ever before in history.

One rogue business should not taint the reputation of an entire industry. Unfortunately, the Senate’s knee jerk reaction is typical: The federal government must do something!

As usual, that “something” will result in bigger government, and less freedom and less consumer choice.

Whenever government steps in, it is almost always to our detriment. This case is no different — and America will be all the less healthy for it.


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