Biopharmaceutical firm Cephalon revealed in its annual report that it has received a subpoena from the USPS Office of the Inspector General, regarding its drug Fentora, also known as fentanyl. Neither the company nor the OIG would provide additional details on the subpoena, but it may be related to an earlier investigation into Cephalon’s promotion of “off-label” uses for some of its products. Here is the statement from the company’s annual report:
In January 2011, we received a subpoena duces tecum (for documents) from the U.S. Postal Service Office of Inspector General (“Postal Service”) in connection with an investigation relating to Postal Service employees’ workers’ compensation claims. The subpoena requests that we provide to the Postal Service documents pertaining to FENTORA. We understand that this investigation is being conducted by the Postal Service in conjunction with the Civil Division of the United States Attorney’s Office in Philadelphia. We are in the process of responding to the subpoena and intend to cooperate fully.
In 2008 the company agreed to pay $425 million to settle charges that it had improperly marketed another fentanyl product, Actiq. The Department of Justice at the time pointed out that the company had “promoted Actiq for use in patients who were not yet opioid-tolerant, and for whom it could have life-threatening results.” The drugs are opiates- similar to heroin, and are sold in the form of lozenges on a stick- in effect, heroin lollipops.
The USPS OIG participated in the 2008 investigation, and commented:
These types of investigations are an important part of the Postal Service Office of Inspector Generalâ€™s mission to prevent and detect fraud, waste, and misconduct in the Postal Service, and to promote the integrity and efficiency of postal programs. This includes federal programs that the postal service participates in or contributes to such as the federal workersâ€™ compensation program, under which these drugs were paid for by the postal service. Drugs promoted off-label can lead to potential safety issues and unnecessary, inflated program costs for the Postal Service and others.
Note to whistle-blowers: three former Cephalon employees who informed on the company received $46 million for their troubles…