The FDA has just issued regulations and policy positions on compounding pharmacies that sell their products across state lines. A compounding pharmacy is a pharmacy that practices like most pharmacies did until well into the 20th century: Pharmacists actually compound chemicals into a medicine, rather than dispensing a pill or vial made by a manufacturer. That is why the mortar and pestle is the traditional symbol of pharmacy. Traditionally, the Food and Drug Administration did not scrutinize these pharmacies. In 2012, the New England Compounding Center was responsible for sending impure steroid injections to twenty states, which caused an outbreak of fungal meningitis that infected 751 people and killed 64. Congress reacted by passing amendments to the Drugs Quality and Security Act in November 2013, giving the FDA the power to regulate compounding pharmacies.
The question nobody asked was: Is this necessary? There was no general crisis of quality in compounding pharmacies. Authorities in Massachusetts shut down two pharmacies and investigated three more. The New England Compounding Center went bankrupt in December 2012.
This type of crisis always causes federal overreach, the negative consequences of which take years to appear. A previous example is the Kefauver-Harris amendments of 1962, which granted the FDA the power to prevent a drug from coming to market unless its manufacturer could demonstrate “efficacy” (whatever that means) as well as safety. This has significantly increased the cost of drug development, and killed more patients than it has saved. Whether allowing the FDA to regulate compounding pharmacies will have similarly painful effects, only time will tell. Nevertheless, the FDA’s record suggests pessimism.
Come on! The purpose of gummint regulation is to concentrate wealth and power in the medical-pharmaceutical-hospital-insurance complex, and compounding pharmacies, like Canadian and Mexican drugs and choice of independent doctors, were standing in the way of “progress.”
We can’t possibly have independent pharmacies and physicians standing in the way of an increased government presence in healthcare. The “gummint” knows what’s best for us, and they can’t keep an eye on some cowboy outlaw pharmacies!
Yes, any time there is a (relatively) isolated problem the government tries to come to the “rescue” and exploit the situation. However, as Milton Friedman said, rather than the government protecting the consumer, it is more necessary to protect the consumer from the government.
Exactly! We know what is in our best interests, and its not more government!
There never is any wider problem threatened, only the idea that there COULD be. But, as noted here, more often than not the government’s “solution” is worse for consumers though.
One bad apple ruins the bunch.
Because the government’s solution entails less choice and competition and more regulation. If consumers really want power, they should sought after solutions that aren’t in the government interests.
“The FDA has just issued regulations and policy positions on compounding pharmacies that sell their products across state lines.”
When there is a slip up that causes harm to individuals, you can expect a government overreaction. It is quite possible this is an isolated incident, but it gives an opportunity for the government begin to shut out independent pharmacies.
Something like this is no different than a drug recall that is done by one of the big pharma companies. However, since this was done by a compounding pharmacy and not a massive corporation, they will get punished.
I totally disagree. There have been massive problems with compounding pharmacies. NECC just brought more light to the problems. NECC was not the only incident involving deaths and illnesses form compounded drugs. Congress is the one who passes laws. They are the one who acted and they acted in part because state boards refuse to do anything, compounding pharmacies put up constant refusals to the FDA’s and the state boards that do acts request to even inspect the pharmacies. Totally not an isolated incident and anyone who says is either distorting the facts or not knowledge. Franks’, Apothecure, Nuvision, and now the death of a baby.