Ex-Glaxo Lawyer Discusses FDA Investigation of Wellbutrin

Ex-Glaxo Lawyer Discusses FDA Investigation of Wellbutrin

October 4th, 2012 // 2:33 pm @


Last year, the federal government lost a closely watched case in which a former GlaxoSmithKline lawyer had been indicted for obstructing an FDA investigation into whether the drugmaker illegally marketed its Wellbutrin SR antidepressant as a diet pill. The indictment initially signaled a rare effort by the feds to hold a pharma exec accountable for breaking the law, a move that alarmed drugmakers and their legal teams.

A federal trial judge, however, tossed the case, which turned, in part, on whether the lawyer, Lauren Stevens, should have been able to claim she relied on the advice of outside counsel during her interactions with the FDA. The Stevens legal team had argued she did not attempt to conceal information, but rather did not produce info in the absence of an FDA subpoena. They also maintained she did not make false statements to the agency (back stories here, here, here and here).

The dismissal was, of course, embarrassment to the feds. As for Stevens, the now-retired attorney has kept a low profile. A few days ago, however, the now-retired attorney made a public appearance at the annual meeting of the Association of Corporation Counsel and talked about her experience. “You can’t go through something like this without being changed, and for the better,” she told the crowd, according to Corporate Counsel.

In her discussion, she reviewed events leading to the indictment, an episode that actually began in 2002, when the FDA sent Glaxo a letter about possible off-label marketing of Wellbutrin. Since the audience was filled with lawyers, she attempted to convey some of the lessons that she learned. For example, she reportedly drew laughter when noting that it’s best to have outside counsel sign letters to agencies. In other words, let someone else be first on a firing line.

What else? Using “outside counsel was absolutely critical. Be sure it’s someone who will be there for you six or seven years later.” And she cautioned that taking detailed meeting notes can prove useful years later. “This isn’t a lesson about don’t take notes, but about take effective notes,” she said, according to Corporate Counsel. “…Had we not had those notes I wouldn’t have remembered all those things we did back in 2003.” But, she added, be careful about writing e-mails, which can be admitted as evidence.

Finally, she told the crowd not to make legal arguments in letters to agencies. She recalled, Corporate Counsel writes, that her letters to the FDA contained “a lot of advocacy and zealous representation. If I were to do it again, I think I would set a different tone in the letters.” Perhaps it may be worth keeping in mind what Sgt. Joe Friday of Dragnet fame used to say: “Just the facts, ma’am.”

“I think the criminalization of the practice of law is here, and I don’t think it’s necessarily going away,” Stevens told the WSJ Law Blog. “The government will continue to be aggressive in looking at in-house counsel. I know sometimes it feels like we have a target on our back.” Since the dismissal, however, the feds have not attempted to bring a similar case.


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