PHARMACEUTICAL COMPANY LAWYER CHARGED WITH OBSTRUCTION AND MAKING FALSE STATEMENTS
BOSTON, Mass. – An attorney for a major pharmaceutical company was charged with
obstruction and making false statements 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 alleges 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 alleged 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 further 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. The company allegedly 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 alleged 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. A legal memorandum was allegedly 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 offlabel
promotion of [the drug] that may be used against [the company] in this or in a future
investigation.” Instead, Stevens represented that the company’s responses to the FDA’s requests
was “final” and “complete.”