Investigation Into Meningitis Outbreak Now Includes State Inspectors

The federal government’s investigation into the recently outbreak of fungal meningitis, which occurred after patients were treated for back pain with contaminated steroids, has expanded to the state regulators who were supposed to be monitoring compounding pharmacies in Massachusetts.

The outbreak may be linked to steroid injections manufactured by the New England Compounding Center in Massachusetts. After a Tennessee man contracted fungal meningitis, federal investigators visited the NECC and found fungus in several vials of steroids. NECC voluntarily recalled the steroids; however, over 13,000 people had already received injections. Since the recall, 184 people have been diagnosed with fungal meningitis and 19 of those people died.

Consumer health advocates became critical of federal regulation of compounding pharmacies after this event, saying that the lack of regulation made it more likely that catastrophic events like this could occur. Compounding pharmacies are not overseen by the federal government; thus, there is greater chance that they deviate from standard procedures while making drugs. Advocates were concerned because compounding pharmacies make a wide variety of drugs to treat conditions from cancer to common colds.

Despite the lack of federal regulations, however, compounding pharmacies aren’t completely unregulated. State regulation agencies are supposed to oversee them. Thus, the U.S. House of Representatives has asked the Massachusetts Board of Pharmacies to share any information it had on New England Compounding Center prior to the outbreak with Congressional representatives. This testimony will allow federal lawmakers to determine whether state regulators did their job. It is unclear what will happen if it is determined the state regulators failed to regulate New England Compounding Center appropriately.

In the meantime, NECC has surrendered its license to manufacture pharmaceuticals in Massachusetts and is downsizing its workforce. It has also lost the right to license drugs in Michigan, where a large number of patients have been affected by the outbreak.

The investigation has already revealed that the FDA was concerned about the safety of steroids manufactured by NECC in 2006; state regulators are being called in to help determine why the company was still allowed to manufacture these drugs for six years after the initial concern.

NECC is already facing one lawsuit for allegedly causing a patient to get fungal meningitis; other lawsuits may follow. Senator Richard Blumenthal of Connecticut is calling for a criminal investigation of the company as well.