by: Jeff S. Gibson, Attorney
The fungal meningitis outbreak that has spread across the nation which has sickened over 250 people and left 23 dead has raised many questions about compounding pharmacies. The Centers for Disease Control and Prevention (CDC) has been providing updates on the outbreak since the recall was issued on September 26, 2012 and has stated that is working in conjunction with local and state health agencies and the Food and Drug Administration (FDA) in its investigation.
It seems that the two questions that everyone wants answered are:
1. What is the actual source of the contamination?
2. Why did the FDA not have regulations in place to avoid this catastrophe?
If only it were as simple as that. As far as the answer to the first question, that is exactly what the CDC is working on right now. Three lots of a preservative-free methylprednisolone acetate injection manufactured by the New England Compounding Center (NECC) were implicated in this outbreak. Recently, the CDC was able to confirm the presence of Exserohilum rostratum in one of the lots. Exserohilum is a brown-black mold and has been identified as the predominant pathogen in this outbreak. Results are currently pending on the testing of the other two lots.
The bigger question is HOW did this happen. Since this steroid injection is a drug, it seems obvious that the FDA was in charge of regulating the manufacturing, advertising, and disbursement, right? Wrong.
The NECC is a compounding pharmacy, not a drug manufacturer. A compounding pharmacy creates custom medications for patients by blending drugs and ingredients to meet the needs of a specific patient per a doctor’s order. One simple example of compounding is the creation of a medicine in the form of a flavored suspension that can be given to a child instead of a difficult to swallow pill. Other examples can include drugs that are created by a pharmacist that omit certain preservatives or fillers to avoid an allergic reaction in a patient.
The steroid injections that are the subject of the fungal meningitis outbreak came from a compounding pharmacy. Upon further investigation, it appears that the New England Compounding Center was not filling specific prescription orders from doctors but was mixing up large batches (14,000 individual injections in this case) of medicines and selling them to medical facilities. This type of behavior is more like that of a drug manufacturer and should be subject of FDA regulation.
However, for years compounding pharmacies have lobbied lawmakers to keep FDA regulation away from the daily activities of making these drugs claiming that this type of oversight was already in the hands of the state board of pharmacy. The International Academy of Compounding Pharmacists (IACP) has spent over $1 million in the past 10 years to fight legislation that was aimed at giving the FDA the authority to inspect compounding facilities as well as restrict the distribution of compounded drugs across state lines.
The most recent effort to regulate compounding pharmacies came in 2007 when Massachusetts Senator Ted Kennedy along with Kansas Senator Pat Roberts and North Carolina Senator Richard Burr introduced the Safe Drug Compounding Act. This act was aimed at ensuring patient safety by instituting many changes, one of which was to establish limits on the quantity of a drug that could be prepared by a pharmacy. This would require facilities that mass produce drugs to fall under FDA guidelines and be treated the same as pharmaceutical manufacturers. Smaller custom compounding pharmacies would continue to be regulated by the state board of pharmacy where the facility is located. The act would have also required compounding pharmacies to establish sterilization protocols for drug preparation.
The Safe Drug Compounding Act was defeated in large part due to the lobbying efforts of the IACP leaving each state’s board of pharmacy responsible for regulating the practices of these facilities. The impact of the nationwide fungal meningitis outbreak has once again put the spotlight on compounding pharmacies and their practices. Legislators are already asking for answers and discussing the need for federal regulation. In the meantime, people who have been seriously injured, or had a loved one die as a result of the contaminated injections are seeking legal action for their damages.
(photo courtesy of CDC website)