Cephalon Corporate Integrity Agreement

It recalls a similar agreement signed in 2006 by Eli Lilly on the off-label marketing of Evista. This agreement essentially took over the full supervision of Evista`s marketing to prosecutors. It is still in force. False “reverse” claims are situations where the alleged loss to the government did not result from an inappropriate payment to a producer (i.e. If the revenues are wrongly reimbursed under Medicare), but in which the government is entitled to the manufacturer`s payments. In this case, the reporters claimed that Cephalon had nullified false allegations by falsely attesting to compliance with the CIA`s reporting obligations. The company did so to evade its obligation to pay penalties under the agreement, the complaint says. On 29 September 2008, the attorney general and us attorney in office in Philadelphia announced a criminal investigation and a civil transaction with the pharmaceutical company Cephalon. The case includes the off-label marketing of three drugs, Actiq, Gabitril and Provigil, for applications other than those authorized by the Food and Drug Administration. The company is accused of distributing mislabeled drugs with insufficient instructions for use. In its Plea agreement, Cephalon agrees to pay US$50 million to resolve this information, including a fine of $US 40 million and a forfeiture of $US 10 million. In the civil agreement between Cephalon, the United States and various states, Cephalon agreed to pay US$375 million plus interest to resolve False Claims Act claims by the United States Medicaid and Medicare Trust Funds and other federal programs. The state`s and the District of Columbia`s Medicaid programs will share $116 million of the civil transaction.

The civil settlement also resolves four complaints that Tam (“whistleblowers”). The relators will receive $46,469,978. Cephalon has entered into a five-year investment firm agreement with the government, which requires, inter alia, that Cephalon send doctors a letter informing them of this resolution and give them the opportunity to report any questionable behavior by commercial agents. The United States District Court for the Eastern District of Pennsylvania, the Honourable Harvey Bartle III, stopped on October 10 A hearing was held on October 12, 2008. The court accepted Cephalon`s admission of guilt over the information. On 10 October 2008, the Court delivered its Judgment. United States v. Cephalon, Inc., 2:08-cr-00598 (E.D. Pa.) In 2008, Cephalon (now acquired by Teva) paid $425 million for off-label advertising practices related to a number of its products. The company entered into a CIA with the Office of the Inspector General of the Department of Health and Human Services and approved a wide range of corrective actions, including regular compliance certifications.

Undercover report on the industry`s relationship with the NHS inspired discussion for the UK`s sun law A doctor associated with similar activities got caught last year by the FDA in this sort of thing. Cephalon will pay $50 million to resolve off-label marketing charges, and $375 million plus interest to resolve False Claims Act charges. .