A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of 64 people. In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and other infections among patients who had received contaminated steroid injections from the New England Compounding Center (NECC) in Framingham, Massachusetts. The NECC was classified as a compounding pharmacy. The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can't be met by commercially available drugs. In October 2012, an investigation of the NECC revealed the company had been in violation of its state license because it had been functioning as a drug manufacturer, producing drugs for broad use rather than filling individual prescriptions. In December 2012, federal prosecutors charged 14 former NECC employees, including president Barry Cadden and pharmacist Glenn Chin, with a host of criminal offenses. It alleged that from 2006 to 2012, NECC knowingly sent out drugs that were mislabeled and unsanitary or contaminated. In a congressional hearing the FDA Commissioner was asked why regulators at the FDA and the Massachusetts Board of Pharmacy did not take action against the pharmacy years earlier. The legislators were told that the agency was obligated to defer to Massachusetts authorities, who had more direct oversight over pharmacies. The FDA Commissioner also stated, "In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding." The Drug Quality and Security Act (H.R. 3204, 113th Congress), a bill to grant the FDA more authority to regulate and monitor the manufacturing of compounding drugs, became law on November 27, 2013. The incident resulted in numerous lawsuits against NECC. In May 2015, a $200 million settlement plan was approved that set aside funds for victims of the outbreak and their families.
Outbreak In September 2012, an outbreak of fungal meningitis was reported in the United States. The U.S. Centers for Disease Control and Prevention traced the outbreak to fungal contamination in three lots of a medication called methylprednisolone used for epidural steroid injections. The medication was packaged and marketed by the New England Compounding Center (NECC), a compounding pharmacy in Framingham, Massachusetts. Doses from these three lots had been distributed to 75 medical facilities in 23 states, and doses had been administered to about 14,000 patients after May 21 and before September 24, 2012. Patients began reporting symptoms in late August, but, because of the unusual nature of the infection, clinicians did not begin to realize the cases had a common cause until late September. Infections other than meningitis were also associated with this outbreak, which spanned 19 states. As of March 10, 2013, 48 people had died and 720 were being treated for persistent fungal infections. In November 2012, some patients recovering from meningitis were reported to be experiencing secondary infections at the injection site. Although no cases of infection were reported to be associated with any other lots of medication, all lots of all medications distributed by NECC were recalled in separate actions by NECC and regulators. Subsequent analysis identified some contamination in other lots. On October 9, 2012, members of the United States Congress asked federal health officials for briefings on the outbreak as a first step toward possible legislative action to strengthen federal drug safety regulations. On November 14, 2012, members of a congressional committee investigating the outbreak accused the Food and Drug Administration (FDA) of failing to prevent the crisis by moving too slowly against the Massachusetts pharmacy. FDA commissioner Margret Hamburg testified that the agency's efforts to address problems at the compounding center had been hamstrung by Congressional interference, conflicting court rulings regarding FDA jurisdiction, and tenacious litigation by the compounding center itself. At the same hearing, the co-owner of NECC chose to plead the Fifth, refusing to answer all questions. By mid-December, over 400 lawsuits had been filed against NECC. In October 2012, Massachusetts shut down two more compounding pharmacies over sterility concerns after they conducted a surprise inspection. In December, unexpected inspections of three more Massachusetts pharmacies found problems as well. On December 21, 2012, the New England Compounding Center filed for Chapter 11 bankruptcy protection in the Massachusetts district bankruptcy court. On September 4, 2014, pharmacist Glenn Adam Chin was arrested at Boston's Logan International Airport before boarding a plane headed to Hong Kong, and was charged with one count of mail fraud. Chin was responsible for supervising the clean rooms at the NECC and was involved in compounding the contaminated methylprednisolone. The FDA affidavit stated that Chin had used improper sterilization and testing techniques, unsafe practices, falsified cleaning logs, and ordered pharmacy technicians to fraudulently mislabel vials. Chin was the first to be charged in the ongoing inquiry. On December 17, 2014, 14 former NECC executives and technicians, including co-founder and president Barry Cadden, were indicted on a host of federal charges related to the outbreak. Most seriously, Cadden and Chin were charged with helping orchestrate a massive racketeering conspiracy that led directly to 25 of the deaths.
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