Regulatory Focus™ > News Articles > State and Local Officials Launch Criminal Probe of Compounder as FDA Criticized

State and Local Officials Launch Criminal Probe of Compounder as FDA Criticized

Posted 25 October 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) continues to grapple with problems stemming from an outbreak of fungal meningitis caused by tainted steroid injections manufactured by the Massachusetts-based New England Compounding Center (NECC). The saga is now moving steadily into an investigative stage, with state and federal officials announcing the launch of a criminal probe, legislators calling for a government investigation into the compounding sector, and outside groups calling for an investigation into FDA.

(CNN) Federal and state officials have launched a criminal investigation into NECC after identifying a number of potentially criminal acts allegedly perpetrated by the company before the outbreak. The allegations include improper compounding and distribution, improper sterility testing and practices, and failure to follow basic manufacturing standards. More: (Boston Globe) (Med Page Today) (AP)

(House) Representatives Elijah Cummings (D-MD) and John Tierney (D-MA) have both called on the Government Accountability Office (GAO) to investigate the pharmaceutical compounding industry, saying they are interested in knowing, "How many other companies are engaged in similar activity and whether they may be falling through the cracks between state and federal regulating agencies."

(Public Citizen) Advocacy group Public Citizen is calling for an independent investigation into FDA's handling of NECC, saying it, "Failed to use its established regulatory authority to protect the public from the dangerous practice of large-scale drug compounding."

(Pharmalot) Massachusetts' governor, Deval Patrick, has called for yearly surprise regulatory inspections for compounding pharmacies operating in the state.

(FDA) Commissioner Margaret Hamburg praised state and local health officials, whom she said had been instrumental in linking NECC's products to the meningitis outbreak and bringing the matter to FDA's attention.

(New York Times) Would you build a drug production facility next to a recycling center? For NECC's owners, the answer is 'Yes.' The New York Times reports this and other disturbing findings about the company's sterility practices that may have led to the outbreak, though they caution the source of the contamination has not yet been found.

(Reuters) Lawsuits against NECC and various other physicians and clinics which injected the drug into patients have started, and their success may hinge on a single question: is an injection a product or a service?

(Knox News) FDA made headlines earlier in the week when it released a massive, sprawling list of facilities which had been sent NECC products. The problem: It contained tons of inaccuracies, forcing it to issue an amended list just a day later. Providers and state health officials said they were frustrated with the errors, saying it confused patients and created more work for regulators.

(Boston Herald) NECC's pharmacist has surrendered his license in the state of Tennessee, where the meningitis outbreak has impacted patients the hardest.

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