December 3, 2012
A federal grand jury reportedly has launched an investigation into the compounding pharmacy at the center of the fungal meningitis outbreak that has killed 36 people in seven states.
The grand jury in Boston has begun issuing subpoenas to former workers of the New England Compounding Center (NECC), the Boston Globe reported over the weekend, citing unnamed sources. It is expected to hear from at least some witnesses in court as soon as this week.
Grand jury investigations are a step prosecutors take before determining whether or not to press charges.
The newspaper reported workers from at least one other company, Massachusetts’ Medical Sales Management, which handled sales and administrative support for the Framingham, Mass.-based NECC, also received subpoenas.
When federal agents raided NECC’s headquarters in October, U.S. Attorney Carmen Ortiz confirmed at that time “this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center.”
Agents from the FDA’s Office of Criminal Investigations were pictured carrying boxes of documents out of the office.
So far, more than 500 individuals and 36 deaths have been tied to tainted preservative-free methylprednisolone acetate made by NECC and shipped to pain clinics in 23 states. More than 14,000 patients were exposed to the potentially contaminated injection.
A series of reports and inspection results released since the outbreak started in late September paint a picture of a negligent pharmacy.
Inspection reports from the FDA stated NECC found numerous instances of bacteria and mold growing in rooms meant to produce sterile products months before the current outbreak. Despite knowing this, the regulator also said NECC failed to document action to prevent contamination of its sterile drug products.
A report from the House Energy and Commerce Committee stated Massachusetts Department of Public Health inspectors found NECC workers cleaning sterile compounding areas when it visited in late September. They also found signs of bleach decontamination.
“Despite NECC’s apparent attempt to present the facility as compliant, state investigators still identified ‘serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public’s health and safety at risk,’ ” the House report stated.
Regulators also found NECC shipped products before it received sterility test results.
During a hearing before that committee, NECC President and co-owner Barry Cadden appeared to testify but declined to answer any questions, invoking his Fifth Amendment rights.
The Globe reports prosecutors are expected to focus on potential charges of fraud, selling tainted drugs, and defrauding Medicare and Medicaid. The crimes carry sentences of 3 years to 20 years in prison.
Since the outbreak, NECC, along with sister company Ameridose, has recalled all of its products and shut down completely. The company also faces several civil lawsuits.
The FDA has tied two other NECC products, cardioplegic solution and triamcinolone acetonide epidural injection, to possible meningitis infections.
Members of Congress sternly questioned FDA Commissioner Margaret Hamburg, MD, in separate hearings in the House and Senate held on back-to-back days. Lawmakers questioned why the FDA didn’t do more sooner to stop the NECC if it knew of questionable practices.
Hamburg said the FDA’s authority over compounding pharmacies is “limited, unclear, and contested” as pharmacies are regulated by state pharmacy boards, while the FDA oversees drug manufacturing. The line is blurry over whose responsibility it is to regulate companies like NECC which operate like small manufacturers, the FDA said.
Senators seemed more open to the idea of giving the FDA and state boards of pharmacy a more clear role over who regulates such compounders.