House Democrats Unearth Rampant Lack Of Oversight In Compounding Pharmacy Industry

House Democrats led by Rep. Ed Markey, D-Mass., released a report Monday highlighting a lack of oversight of compounding pharmacies like the one responsible for the outbreak of fungal meningitis last year that killed 53 people and sickened 733.

Named "State of Disarray," it includes five main findings, including a general lack of information among state boards of pharmacy regarding which pharmacies engage in compounding, the mixing of customized medications based on doctors' prescriptions.

Only two states, Mississippi and Missouri, routinely track the number of compounding pharmacies in their state and only 32 are able to provide historical data on the number licensed in their states.

Furthermore, none of the state boards currently require pharmacies to disclose the volume of drugs they produce or whether or not they are sold across state lines.

The survey unearthed a significant lack of oversight in the production of even sterile compounding services, indicating that only 13 states know which pharmacies include this service. Of the 13, only five have inspectors trained to identify problems with sterile compounding.

When it comes to maintaining pharmacy inspection records, less than half of the nation's 50 states keep any historical record for compounding pharmacies necessary for identifying systemic and repeated safety problems. 

The report further revealed a complete absence of state-to-state policing. Thus, when issues arise with out-of-state pharmacies, states do not consistently inform the state of origin or the FDA.

Finally, despite general increases in state board pharmacy budgets, the number of inspectors remains low with an average of just 5 inspectors employed by each state.

In all, only five state boards were able to estimate the number of inspections performed at compounding pharmacies.

The problem, according to the report, is that, unlike drug manufacturers, compounding pharmacies do not have to register with the Food and Drug Administration (FDA) or follow any of its specified procedures.

To counteract this problem, Markey publically voiced his support that the FDA receive more power on the subject of regulating these pharmacies, saying in a press release, "Even states with stronger compounding standards cannot effectively police the activities of pharmacies in 49 other states that sell drugs across state lines, which is why the FDA must step in and protect public health."

Opponents to this idea, namely Republicans on the House Energy and Commerce Committee and compounding industry lobbyists, argue that the FDA could have shut down the company responsible for the meningitis outbreak with existing powers.