Regulators Scramble to Contain Compounding Crisis as Industry Scrutinized

Posted 16 October 2012 | By

The US Food and Drug Administration (FDA) continues to warn consumers and healthcare providers about drugs manufactured by the New England Compounding Center (NECC), saying two additional drugs could be contaminated with dangerous types of fungus.

(Regulatory Focus) - FDA has warned of two additional drugs potentially infected with either fungal meningitis or aspergillus fumigatus, possibly widening the pool of patients affected by drugs compounded at NECC. The agency said it has not yet been able to substantiate the connection, and is continuing to investigate.

(CNN) - The Centers for Disease Control and Prevention (CDC) has announced it is aware of 214 cases of fungal meningitis and at least 15 deaths. The form of fungal meningitis found in the vials is particularly pernicious because it is difficult to detect.

(New York Times) - Sen. Richard Blumenthal (D-CT) has called for an, "Immediate criminal investigation" into NECC's actions. It remains unclear whether that investigation would be headed by Massachusetts' attorney general, federal authorities or both.

(Reuters) - FDA's efforts over the past decade to regulate compounding pharmacies have been routinely stymied by lobbying efforts spearheaded by the pharmacies, which have cumulatively spent more than a million dollars to defeat various efforts over the years. During that time, thousands of patients have been injured or killed by the lightly regulated products.

(The American) - FDA's problem is twofold: Murky regulatory authority and a lack of resources with which to regulate the thousands of compounding pharmacies that exist in just the US. Further, as FDA's inspections have gotten to be more comprehensive, many consumers and providers have been driven to these pharmacies by drug shortages, placing them at even greater risk for safety issues.

(The New York Times) - Compounded drugs have traditionally existed as one-off products specifically compounded for a single patient. NECC, meanwhile, was producing steroid products by the tens of thousands, blurring the line between compounder and pharmaceutical manufacturer.

(Boston Herald) - The meningitis outbreak marks the second major health scandal in Massachusetts in as many months, placing a harsh spotlight on Gov. Deval Patrick. Last month, the state's drug testing agency was rocked by allegations that a "rogue chemist" could have mishandled tens of thousands of samples in as many as 34,000 legal cases.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles