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Acquittal of Glaxo Lawyer Suggests It's OK to Lie to the FDA

The sudden and unusual acquittal of former GlaxoSmithKline (GSK) vp/associate counsel Lauren Stevens creates a dark new recipe for pharma lawyers who deal with the FDA: If it isn't a response to a subpoena, the ruling implies, it's OK to to lie to the federal agency.

In the case, Stevens was charged with making false statements to the FDA. In pretrial motions, she all but admitted she concealed from the FDA evidence that the company was illegally promoting the antidepressant Wellbutrin SR as a diet pill. In her defense, Stevens argued she relied in good faith on the advice of her lawyers, who were helping her respond to the FDA's requests.

The acquittal came in a directed verdict from federal judge Roger Titus -- a 2003 appointee of former president George W. Bush -- before Stevens even put on a defense. It does three damaging things in terms of the public's confidence in corporations:

  1. It suggests that corporate lawyers need not fear prosecution: Stevens demonstrated her innocence through her insistence that she relied on other lawyers to guide her, even though she knew she was sitting on 30 or more GSK slide shows in which Wellbutrin was illegally touted as a diet pill.
  2. It hurts the ability of prosecutors to find cooperating witnesses in their ongoing probe of GSK, as execs won't believe they are in danger of being charged or found guilty.
  3. And it strongly suggests that lying in response to an FDA request for information, rather than a subpoena, carries no legal penalty as long as your lawyer said it was OK.
Even the judge admitted that Stevens had not told the FDA the whole truth during the Wellbutrin probe:
"The responses that were given by the defendant in this case may not have been perfect," he continued. "Now, even if some of these statements were not literally true, it is clear that they were made in good faith which would negate the requisite element" --- intent to commit a crime --- "required for all six of the crimes charged in this case."
On top of that, Stevens' motion to acquit argued that she was innocent because the "FDA failed to engage" her invitation to one more meeting at which she planned reveal the slides. She didn't tell the FDA what would be revealed at the meeting, and she previously told the FDA that her production of evidence to them was "final," "last" and "complete."
And Stevens' paralegal testified that she made "untrue" statements to the FDA, according to the prosecution's motion against acquittal:
The defendant's paralegal also testified that the answer the defendant planned to give the FDA â€"- if asked to explain her failure to produce the documents â€"- was "untrue."
Memos that Stevens had written and received suggested she knew she was doing something wrong. In a handwritten note to herself about a "Dr. Pradko," a GSK man whose slides had not been turned over to the FDA because they touted off-label dieting uses for Wellbutrin SR, Stevens wrote, "Govt might say: FDA: off-label -- Co. liked it/condoned it":

Similarly her lawyers warned that one of the "cons" of turning over the slides was:

Provides incriminating evidence about potential off-label promotion of [Wellbutrin] that may be used against [GSK] in this or in a future investigation.
Before Judge Titus ruled, prosecutors warned him:
Holding that corporations and their attorneys are free to mislead and deceive the government (and may promise but then not provide information when it turns out to be damaging), so long as the government's request does not come in the form of a subpoena, would set dangerous precedent that if followed could cripple the ability of a myriad of government regulators to carry out their missions.
That "dangerous precedent" is now in place.


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