In a striking departure from usual practice, the Justice Department has brought criminal charges against a former executive of pharmaceutical giant GlaxoSmithKline, accusing her of making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin.
The indictment, which was announced on Tuesday, marks a dramatic shift away from punishing drug makers for wrongdoing without charging company executives.
“This is absolutely precedent-setting — this is really going to set people’s hair on fire,” Douglas B. Farquhar, a Washington lawyer and close observer of the drug industry, told The New York Times. “This is indicative of the FDA (Food and Drug Administration) and Justice strategy to go after the very top-ranking managing officials at regulated companies.”
The indicted official, Lauren C. Stevens of Durham, N.C., is a former associate general counsel for GlaxoSmithKline. The charges stem from a series of letters she penned in 2003, which denied that doctors had spoken at company events and promoted uses for Wellbutrin that the FDA hadn’t approved.
Lawyers for Stevens, 60, denied the allegations and predicted she will be acquitted.
The announcement came after months of hints from the FDA that it was preparing to crack down on wayward executives. In April, Eric Blumberg, the agency’s deputy chief counsel for litigation, told a roomful of drug industry officials, ”Very soon, and I have no one particular in mind, some corporate executive is going to be the first in a long line.”
Blumberg struck a similar note last month, when he told a conference on drug industry law, ”If you are a corporate executive — or counsel advising such a client — do not wait for the first case to decide now is the time to comply with the law.”
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