Criminal investigators from the Food and Drug Administration were at the New England Compounding Center in Framingham, Mass., on Tuesday, officials said, in the first public indication that the federal government was preparing a case against the company linked to a deadly meningitis outbreak.
Federal and state officials have said they believe that contaminated pain medicine from New England Compounding had caused the deaths of 16 people and sickened more than 200. And while investigators from the F.D.A’s regulatory section have been in and out of the company’s offices since early October, Tuesday appeared to have been the first time criminal investigators were on site.
The F.D.A. is a regulatory agency, but embedded within it is a section devoted to criminal prosecutions. The agents at the company Tuesday were from that section.
An agency spokesman, Steven Immergut, confirmed that agents from the F.D.A.’s Office of Criminal Investigations were at the company on Tuesday, but gave no details. The office looks into suspected violations of federal laws meant to protect public health. Among the possible violations it investigates are making and selling unapproved drugs, and illegally importing F.D.A.-regulated products.
A spokesman for New England Compounding, Andrew Paven, said that agents had come with a warrant. Images of the entrance of the company cordoned off with yellow tape were shown on television news.
Late on Tuesday, the company’s lawyer, Paul Cirel, objected to what he called a “search” by federal agents, but said the company would cooperate.
“It is difficult to understand the purpose of this search, since we have been clear that New England Compounding Center would provide, and has provided, anything requested,” he said in a statement. “We’ve been clear that warrants weren’t needed; asking would have produced the same result.”
A spokeswoman for the United States attorney’s office in Boston, Christina Sterling, said the warrant was sealed, and its details were not publicly available. The attorney’s office also announced that it was investigating New England Compounding, Ms. Sterling said, though no officials from that office were at the company.
The action comes as Representative Edward J. Markey, a Democrat from Massachusetts who represents the district where the company is based, sent a letter to Attorney General Eric H. Holder Jr., demanding an investigation into whether the company had violated laws on which controlled substances can be sold. Last week, Richard Blumenthal, a Democratic senator from Connecticut, demanded that Mr. Holder begin an investigation into New England Compounding.
Also last week, Gov. Deval Patrick of Massachusetts said that New England Compounding had “misled” investigators, engaging in what appeared to be legal violations by selling large quantities of drugs without an individual patient name for each prescription.
But federal officials on Tuesday warned the public not to jump to conclusions. In a statement, United States Attorney Carmen Ortiz said, “I think that it is entirely premature to suggest what the results of the investigation will be.”
The drug implicated in the outbreak is methylprednisolone acetate, a steroid.
Source: New York Times at http://www.nytimes.com/2012/10/17/health/investigators-visit-office-tied-to-meningitis.html