Bloomberg.com reports that a former officer and general counsel for GlaxoSmithKline
(GSK), a London-based drug manufacturer, was indicted on November 8, 2010,
for making false statements to the FDA and with obstructing an FDA investigation.
In 2002-2003, the FDA was investigating the promotion of Wellbutrin SR, an antidepressant drug, for possible uses not approved by the FDA. The attorney, Lauren Stevens, now residing in North Carolina, is charged with making false statements in a series of correspondence with the FDA and with withholding documents that could have proved that Wellbutrin SR was being promoted for uses such as weight loss, which had not been approved by the FDA.
Among other things, Stevens had sent letters to various doctors and had learned about the improper and illegal promotion of the drug. GSK had paid at least two doctors to give about 1,000 promotional talks to other doctors promoting the off-label (non-approved) use of the drugs. The indictment alleges that Stevens knew about the off-label promotions but concealed such materials from the FDA and made false statements concerning her knowledge of the off-label promotion activity.
If convicted on each of the six counts of the indictment, Stevens could be sentenced to a total jail term of up to sixty years. Stevens’ attorneys say that she is innocent of all charges and that she relied on the advice of a nationally prominent law firm that had expertise in working with the FDA.
We wait with bated breath to see whether or not any other officers of GSK will be charged or indicted. And of course, under our law, Stevens is presumed to be innocent of all charges.
“FDA Announces New Restrictions on Avandia Access,” Colorado Business Litigation Lawyer Blog, posted 09/29/2010
“Between a Rock and a Hard Place,” Colorado Business Litigation Lawyer Blog, posted 09/21/2010
“Gene Patents – Rewarding Innovation or Inhibiting Research?“, Colorado Business Litigation Lawyer Blog, posted 09/21/2010