To understand the changing direction of enforcement action, it's helpful to first compare the settlement terms of two off-label promotion suits: Neurontin (gabapentin) and Serostim (somatropin), both negotiated by the United States Attorney's Office for the District of Massachusetts.
Neurontin In 1996, a whistleblower filed a civil qui tam action against Warner-Lambert, alleging that the company engaged in off-label promotion of Neurontin, and provided illegal kickbacks to physicians. The government initiated its own investigation and alleged that the company actively promoted Neurontin for off-label uses through its sales reps, medical liaisons, teleconferences, consultants' meetings, and advisory boards. Based on this, the government brought criminal misbranding charges against the company. The case was settled in 2004 when Warner-Lambert (later acquired by Pfizer) pleaded guilty to two criminal FDCA misbranding violations and settled separate civil charges.
To resolve the criminal case, the company pleaded guilty to distribution of an unapproved new drug, based on the theory that the distribution of Neurontin for unapproved uses constituted distribution of an unapproved new drug. The company also pleaded guilty to distribution of a misbranded drug, based on the theory that the FDA-approved package labeling contained inadequate directions for use for the off-label indications. As part of the settlement, Pfizer/Warner-Lambert agreed to pay $430 million in criminal fines and civil payments, and enter into a CIA with OIG. (See "CIA: Head-to-Head Comparison")
Serostim Between August 2000 and January 2004, six whistleblowers filed civil complaints against various Serono affiliates, alleging violations of the False Claims Act resulting from illegal marketing of Serostim, an FDA-approved drug for the treatment of AIDS wasting.