Colorado health officials filed a complaint against the New England Compounding Center regarding the business practices of that facility. The director of the Massachusetts Board of Registration in Pharmacy took no action regarding the complaint. The NECC has now been identified as the source of tainted medication that has led to more than 30 deaths and hundreds of meningitis cases across 19 states. In the wake of this outbreak, the director of the MBRP has been dismissed. It is not clear if he will face legal action.
Some of the controversy surrounding the meningitis outbreak has targeted the oversight, or lack thereof, brought to bear on businesses in the pharmaceutical compounding business. The Food and Drug Administration has clear authority over drug manufacturers, but compounding companies often fall under the authority of state agencies. The Colorado complaint alleged that the NECC was operating as a drug manufacturer. For instance, compounding pharmacies are required to have advance prescriptions for which they are assembling compounds. The NECC was mass producing compounds without advance prescriptions. By failing to order an investigation or to follow-up on the complaint in any way, the director may have paved the way for the outbreak that threatened thousands of patients nationwide.
Among the many reforms being called for in the compounding industry is more transparent state rules and FDA authority to inspect these facilities. With the FDA already acknowledging that it is understaffed, it is unclear if greater authority would be enough to protect the people who rely on compounded medications.
Thousands of compounding pharmacies are currently operating in the United States. While many are serious about the safety of the medications they provide, there are others that are perfectly willing to cut corners to maximize profits. It is generally left to the affected individuals to pursue compensation through product liability and personal injury lawsuits to protect consumers from dangerous practices like those at the NECC.
Source: Medpage Today, “Meningitis: Head of Pharmacy Board Fired,” by Michael Smith, 8 November 2012