Posted by Kristin Koehler, Lauren Roth and Elizabeth Kolbe
On March 5, 2013, Par Pharmaceuticals (“Par”) became the latest pharmaceutical company to settle allegations of off-label promotion. Specifically, Par resolved criminal misbranding allegations by pleading guilty to a one-count misdemeanor violation of the Federal Food, Drug, and Cosmetic Act. The company also settled related civil allegations that its conduct violated the False Claims Act. In total, the company agreed to pay $45 million in criminal fines, forfeiture, and civil penalties.
The government alleged that Par promoted the use of Megace ES—an appetite stimulant approved for the treatment of patients with significant weight loss as a result of AIDS—for non-AIDS-related geriatric wasting. The government’s alleged evidence of misbranding included actions such as: (i) setting sales goals that exceeded the current sales trends for on-label use, (ii) creating call plans that included long-term care facilities and practitioners who treated geriatric patients, and (iii) adopting a strategy to convert physicians to Megace ES without regard for whether the physicians had been prescribing the competitor product for on- or off-label purposes. As part of this effort, Par’s marketing allegedly failed to acknowledge risks unique to elderly patients and made inaccurate or misleading comparative effectiveness claims between Megace ES and the competitor product, such as suggesting that practitioners “upgrade” their patients to Megace ES and falsely claiming that Megace ES worked faster than the competitor product.
As part of the global resolution of these claims, Par executed a Corporate Integrity Agreement (“CIA”) with the Office of the Inspector General of the Department of Health and Human Services (“OIG”) and the company accepted compliance-related obligations in its plea agreement with the Department of Justice. Among notable aspects of its CIA, Par must adopt restrictions on how incentive compensation is calculated for Megace ES sales professionals and it must institute a clawback mechanism for compensation previously paid to senior executives—two provisions that first appeared in the GlaxoSmithKline CIA (June 2012), but have not been required by OIG since then. Pharmaceutical executives, compliance professionals, and industry advisors had been waiting to see whether these requirements would be unique to GSK (which, to-date, remains the largest single settlement in history), or whether OIG would seek to impose them under other circumstances as well. Interestingly, although intervening settlements with Boehringer Ingelheim (October 2012) and Amgen Inc. (December 2012) were resolved for far higher dollar amounts than Par’s case, related CIAs had not included the incentive compensation provisions. Thus, going-forward, although it is now clear that OIG will seek to extend these provisions to other companies, predicting when it will do so remains a challenge.
The Par settlement concludes three qui tam suits filed in the District of New Jersey: U.S. ex rel. McKeen and Combs v. Par Pharmaceutical, et al., U.S. ex rel. Thompson v. Par Pharmaceutical, et al., and U.S. ex rel. Elliott & Lundstrom v. Bristol-Myers Squibb, Par Pharmaceutical, et al.