Pfizer Settles Off-Label Promotion Charges

Pfizer has agreed to pay $55 million plus interest to settle charges that Wyeth (acquired by Pfizer in October 2009) improperly promoted the drug Protonix (pantoprazole). Protonix is a proton pump inhibitor used to treat forms of gastro-esophageal reflux disease (GERD). It was approved for short-term treatment of erosive esophagitis, a condition that could only be diagnosed using endoscopy. The US Department of Justice, however contends that Wyeth promoted Protonix for treatment of all forms of GERD, including more common forms that could be diagnosed without endoscopy.

According to the Justice Department’s press release, the government alleges that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication, and that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD. In addition, Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn” even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. Finally, the government claims that Wyeth used continuing medical education programs as promotional vehicles for off-label use.

The claims settled by this agreement are allegations only. Pfizer denies these allegations, and there has been no determination of liability. Since August 2009, Pfizer has been under a Corporate Integrity Agreement with the Department of Health and Human Services, which agreement remains in effect.