Food & Drug Administration (FDA) (CLOSED)
United States v. Cephalon, Inc., 2:08-cr-00598 (E.D. Pa.)
Most recent update 10/16/08 (See end of document)
On September 29, 2008, the Attorney General and Acting United States Attorney in Philadelphia announced a criminal information and a civil settlement involving pharmaceutical company Cephalon. The case involves off-label marketing of three drugs, Actiq, Gabitril, and Provigil, for uses other than what the Food and Drug Administration approved. The company is charged with one count of distributing misbranded drugs with inadequate directions for use. In its plea agreement, Cephalon agrees to pay $50 million to resolve this information, including a $40 million fine, and a $10 million forfeiture. In the civil settlement among Cephalon, the United States and various states, Cephalon agreed to pay $375 million, plus interest, to resolve False Claims Act claims by the United States Medicaid and Medicare Trust Funds and other federal programs. State Medicaid programs and the District of Columbia will share $116 million of the civil settlement. The civil settlement also resolves four qui tam ("whistle blower") actions. The relators’ will receive $46,469,978. Cephalon has entered a five-year Corporate Integrity Agreement with the government requiring that, among other things, Cephalon send doctors a letter advising of this resolution, and give them a means to report questionable conduct of sales representatives.
The announcement was issued in a USAO Press Release.
The following documents are available below:
Government's Memorandum for Entry of Plea and Sentencing
Corporate Integrity Agreement
The United States District Court for the Eastern District of Pennsylvania, the Honorable Harvey Bartle III, held a hearing on October 10, 2008. The Court accepted Cephalon's guilty plea to the Information. On October 10, 2008, the Court entered its Judgment.