BOSTON, March 4 /PRNewswire-USNewswire/ -- A Fairport, New York man was charged today in federal court with obstruction of justice.
United States Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation in New England; Joseph C. Moraski, Special Agent in Charge of the Department of Health and Human Services Office of Inspector General; Keith A. Johnston, Resident Agent in Charge of the Defense Criminal Investigative Service; Mark Dragonetti, Resident Agent in Charge of the Criminal Investigative Service of the Food and Drug Administration; Jeffrey Hughes, Special Agent in Charge of the Veterans Administration Office of Inspector General and Randy Miskanci, Postal Inspector in Charge of the United States Postal Service Office of Inspector General announced today that THOMAS FARINA, age 41, of Fairport, New York, was charged in a four count indictment with obstruction of justice.
The indictment alleges that in the summer of 2004, FARINA, then a manager for a pharmaceutical company, altered and deleted documents from his own computer and directed sales representatives under his management to alter or delete from their computers documents that reflected the off-label promotion of a drug, at a time when they knew that their employer, was under investigation for promoting that drug for unapproved uses, and at a time when they had been specifically instructed to preserve all such documents relating to the promotion of that drug. The indictment specifically alleges as follows,
(1) Prior to the summer of 2004, FARINA had directed sales representatives to promote a drug for uses and at dosages that had specifically been denied approval by the Food and Drug Administration. The grounds for the FDA's non-approval had included safety concerns about the drug's use in those contexts and at the higher dosages.
(2) In early 2004, the pharmaceutical company and FARINA and these sales representatives were aware of the fact that the company was under investigation for the promotion of that drug for uses and at dosages for which the FDA had specifically declined to approve this drug. In March 2004, the company issued a document hold with respect to its sales force concerning that drug, including to FARINA and the sales representatives under his direction. In the summer of 2004, the company was in the process of collecting relevant documents from its employees computers relating to the promotion of that drug, in response to the government's investigation.
(3) In the summer of 2004, FARINA changed the clock on his computer and then altered and resaved documents in order to make them appear to have been last altered at an earlier time. He then deleted some or all of these documents. The documents that FARINA so altered and/or deleted included protocols and standing orders prepared or promoted by sales representatives under his direction that provided for the use of the drug at unapproved dosages and for unapproved uses.
(2) Also in the summer of 2004, FARINA caused another sales representative under his direction to alter documents and backdate the alterations on his computer in a similar manner to delete the reference to the drug and/or unapproved uses and dosages in standing order and/or protocols that had been promoted for unapproved uses by that sales representative, at the direction of FARINA.
(3) Also in the summer of 2004, FARINA caused another sales representative to alter and/or delete documents from his computer and the computers of others that reflected FARINA's instructions to his sales representatives to promote the drug for unapproved uses and dosages.
If convicted on these charges, FARINA faces up to 20 years' imprisonment, to be followed by three years of supervised release, and a $250,000 fine for each count of the four counts.
The case was investigated by the Federal Bureau of Investigation, the Department of Health and Human Services Office of Inspector General, the Criminal Investigative Service of the Food and Drug Administration, the Veterans Administration Office of Inspector General, the Defense Criminal Investigative Service and the United States Postal Service Office of Inspector General. It is being prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Sullivan's Health Care Fraud Unit and Trial Attorneys Mark Josephs and Amy Goldfrank in the Office of Consumer Litigation of the Department of Justice in Washington, D.C.
The details contained in the indictment are allegations. The defendant is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.
|SOURCE U.S. Attorney's Office|
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