Cephalon has received another query from the feds. As Pharmalot reports, the company disclosed a subpoena from the U.S. Attorney's Office in New York, requesting information about the company's leukemia drug Treanda. The subpoena follows Justice Department requests for documents about off-label use of the drug--and potential off-label marketing by the company.
The feds have asked in the past for a laundry list of information and documents, Pharmalot writes, including incomplete clinical studies that might support off-label uses for Treanda, and educational and speaker programs that mention off-label use.
The new subpoena cites the Health Insurance Portability and Accountability Act, otherwise known as HIPAA, Cephalon disclosed in a filing with the Securities and Exchange Commission. That's the law that set up privacy protections for patient medical records, among other things; it's why patients have to sign privacy-policy disclosures at hospitals and doctors' offices. "The company is in the process of responding to the subpoena and intends to cooperate fully," the SEC filing states.
This isn't Cephalon's first run-in with the Justice Department. In 2007 it pleaded guilty to a misdemeanor and agreed to pay a $375 million fine to settle an off-label marketing probe. As Pharmalot points out, the settlement included a Corporate Integrity Agreement.
- read the Pharmalot post
- see Cephalon's SEC filing