Valeant: The U.S. investigations

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Valeant Pharmaceuticals International Inc. is the subject of four separate investigations in the United States, the company disclosed in a quarterly filing with U.S. regulators Monday:

• The U.S. Dept. of Justice’s (DoJ) civil division and the U.S. Attorney’s Office for the Eastern District of Pennsylvania said in a letter to Valeant dated Sept. 10 that they are probing possible false claims related to predecessor company Biovail Pharmaceutical Inc.’s reporting of prices in connection with the Medicaid Drug Rebate Program. Valeant said it plans to respond to a request for documents and information.
• Valeant subsidiary Bausch & Lomb Inc. received a subpoena on Sept. 15, from the Dept. of Justice regarding payments made and agreements between B&L and medical professionals; the transactions are related to two B&L surgical products. The company was told by the government that the subpoena is linked to its criminal investigation into possible violations of federal health care laws. B&L is co-operating with the investigation.
• Valeant received two separate subpoenas on Oct. 14 from the U.S. Attorney’s offices in Massachusetts and the Southern District of New York, with requests for materials mostly related to the company’s patient assistance programs. The subpoenas also request information relating to the company’s financial support for patients, distribution of the company’s products, data provided to the Centers for Medicare and Medicaid Services and pricing decisions. The company says it is reviewing the subpoenas and “intends to co-operate with the investigations.”
• A “voluntary request letter” from the U.S. Federal Trade Commission (FTC) was received on Oct. 16 in connection with the FTC’s “non-public investigation” into Valeant’s recent acquisition of Arizona-based Paragon Holdings I Inc. The FTC is requesting that Valeant provide – “on a voluntary basis” – information and documentation related to the Paragon acquisition. Valeant said the letter is being reviewed and that it plans to co-operate with the investigation.