Pharmaceutical Company Lawyer Indicted For Obstructing FDA Investigation Into Promotions of Unapproved Uses of Prescription Drug
An in-house counsel for a large pharmaceutical company was indicted for obstruction of justice and making false statements in relation to an FDA investigation into promotions of “off-label” uses of the companys prescription drugs. According to the indictment, the in-house counsel sent a series of letters to the FDA in response to FDA inquiries that falsely denied that the company had promoted the drug for “off-label” uses, even though the attorney knew that the company had sponsored numerous such promotions. The lawyer also knew that the company had paid physicians to give promotional talks that included information about unapproved uses of the drug. One physician had been paid to speak at more than 500 promotional events and another at 488 such events.
The indictment also alleges that the lawyer did not provide the FDA with certain slides used by the physicians in their presentations even though the FDA specifically requested them. With knowledge that the slide sets contained incriminating evidence, the lawyer wrote the FDA, and instead of producing the slide sets, informed FDA that the responses made to FDA were “final” and “complete”. According to the U.S. Attorney for the District of Massachusetts, “there is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth. Federal agencies such as the FDA cannot protect the public health if the entities and individuals they regulate provide false information and conceal the true facts”.
Each of the obstruction of justice charges carry a maximum penalty of 20 years imprisonment upon conviction. Each of the false statement charges carry a maximum penalty of 5 years imprisonment. The pharmaceutical company for whom the lawyer worked was not charged with a crime and was not identified in the indictment.