Compounding needs federal regulation
Despite a deadly outbreak of fungal meningitis last fall that was traced to a compounding pharmacy in Massachusetts, Congress and the Food and Drug Administration have not resolved basic regulatory issues that underlay the contagion.
Contaminated steroid injections produced by the New England Compounding Center killed 46 people and sicked more than 650 others in 20 states. The company since has ceased operations.
Compounding traditionally involves a pharmacist tailoring a drug to an individual patient's needs. The FDA cited, as an example, making a medication identical to a commercially available drug, but excluding a dye to which a patient is allergic. There are many other examples.
In addition to the meningitis outbreak, there also are many examples where such drugs have done more harm than good. In 2011, a compounding pharmacy repackaged the cancer drug Avastin into single-use syringes, resulting in a dozen patients in the Miami area suffering serious eye infections and, in several cases, blindness. Early in 2012, 33 eye-surgery patients suffered rare fungal eye infections and blindness, in some cases, due to use of an injectable drug produced by a compounding pharmacy in Florida. In Virginia in 2007, the deaths of four cardiac patients were attributed to contaminated drugs used in heart surgery, that were made by a compounder.
The FDA regulates drug manufacturers but compounding pharmacies are regulated by the states - meaning 50 different sets of regulations - even though the compounded drugs often are sold across state lines, as in the contaminated steroids case last year.
Clearly, compounding has evolved from its traditional role and, in some cases, is much more like pharmaceutical manufacturing, and should be regulated by the FDA.
This is a pressing matter of public health. Congress should enable the FDA to draw bright lines between compounding and manufacturing, and give it the appropriate jurisdiction.