Vol 22, 2013 Annals of Health Law 442
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
billions, for potential settlements with the federal government and the state
actions that typically follow in the wake of a DOJ investigation.235
VI. IS THE DOJ’S GOAL TO CHANGE BEHAVIOR OF PHARMACEUTICAL
COMPANIES, OR TO COLLECT HUGE REVENUES FROM INDUSTRY?
It seems apparent that there is no clear public policy view that is shared
by the courts, the FDA, Congress and the health care industry on the issue
of truthful statements that might be made in the context of off-label
marketing. Indeed, one state court said exactly that in a whistleblower case
brought under an Ohio statute.236 The court noted that although the FDA
issued “Guidance” relating to off-label marketing, it had not made binding
statements of public policy: “In view of these considerations, as well as
First Amendment problems with efforts to regulate commercial speech . . .
there is no clear public policy against off-label promotion.”237 Nonetheless,
companies are faced with substantial liabilities, in the form of strong-armed
settlements with the DOJ and a bevy of associated litigation, for what is a
questionable practice at best.
One might question whether the Government’s very aggressive
enforcement actions, leading to billions of dollars in settlements on a
regular basis, have actually changed corporate conduct. Commentators
offer interesting but not totally consistent views. On one hand, Kesselheim
noted that two years after a huge settlement by Pfizer relating to Neurontin
off-label promotion, sales had actually increased by thirty-two percent and
it was estimated that over ninety percent of sales were still for off-label
uses.238 This suggested to her that the prosecution made no difference to
corporate conduct. On the other hand, Osborn believes that American drug
companies have changed behavior in the face of the challenges.239 He
describes the elimination of compensation incentives for sales
representatives based on physicians’ off-label prescribing, limits placed on
the sales representatives’ discretion to engage in discussions with
physicians beyond treatment options, and limits on the specific physicians
the representatives may visit.240
These may be positive steps if the appropriate goal is to eliminate off-label promotion of drugs. But if one is of the view that off-label prescribing
235. E.g., Complaint, Pipefitters Local Union No. 120 Pension Fund v. White, et al.,
No. 12-cv-2624 (N.D. Ill. April 10, 2012) (following Abbott’s set aside of $1.5 billion for a
settlement related to allegations of off-label marketing of Depakote).
236. Long v. Rhone-Poulenc Rorer Pharm., Inc., 1999 U.S. Dist. LEXIS 14196 (N.D.
Ohio Feb. 23, 1999).
237. Id. at *7.
238. See Kesselheim, supra note 90, at 241.
239. Osborn, supra note 22, at 351.