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.