MICHAEL CAROME, MD, via Barbara Holzer [email]
Deputy director of Public Citizen’s Health Research Group, Dr. Carome said today: “The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections prepared by a compounding pharmacy highlights the failure of the Food and Drug Administration’s regulatory oversight of drugs prepared and sold by such pharmacies. What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable.
“The steroid injections, distributed by the New England Compounding Center in Framingham, Mass., have been linked to at least 119 infections in 10 states, and as many as 13,000 people have been exposed. The contaminated injections have been recalled, along with all other products distributed by the New England Compounding Center.
“The large-scale production of a drug — in this case, a drug that is intended to be sterile and injected into patients — appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce.
“Indeed, prior warning letters from the FDA to the New England Compounding Center and other compounding pharmacies appear to indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.
“However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients. By not aggressively enforcing regulations related to drug manufacturing by compounding pharmacies, the FDA has perpetuated a double standard: Traditional drug manufacturers must adhere to rigorous drug-safety standards intended, for example, to prevent the contamination of their products. But so-called compounding pharmacies engaging in large-scale drug production do not. This double standard has resulted in the unfolding public health catastrophe involving hundreds and potentially thousands of patients who received steroid injections for back pain.
“Congress should conduct an investigation into this tragic situation and hold oversight hearings as soon as possible. If current statutes and regulations provided the FDA with authority to prevent this disaster, senior FDA officials should be held accountable. If holes in the agency’s existing legal authority are identified, Congress should act immediately to pass legislation to remedy the situation.”
In “Comments on a Draft of the Safe Drug Compounding Act of 2007” (from 2007), Public Citizen noted: “The size of the pharmacy compounding industry is unknown and there is no requirement for compounding pharmacists to report problems with their products to any regulatory authority.”