by Ben Vernia | November 9th, 2010
The Department of Justice announced on November 9 that it had obtained an indictment of a pharmaceutical company attorney for obstruction and false statements in the company’s response to an investigation of the company’s off-label promotion of a drug. According to DOJ’s press release:
An attorney for a major pharmaceutical company was charged with obstruction and making false statements, the Justice Department announced today. Lauren Stevens of Durham, N.C., was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).
The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or “off-label” – uses.
The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a legal memorandum was prepared for Stevens that set forth the “pros” and “cons” of producing the slide sets to the FDA. According to the indictment, one of the “cons” was that the slide sets would provide “incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation.” Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was “final” and “complete.”
Update: The indictment can be found here.
