Life Sciences

Amgen gets subpoena from NY AG

Pharma Compliance Alert, May 30, 2007

Amgen received a subpoena from New York's attorney general, it said last week in a Securities and Exchange Commission (SEC) filing. The subpoena seeks documents related to the company's promotional, sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications.

Amgen's SEC filing also said that the company received a letter from the Senate Finance Committee "requesting a briefing to discuss the issues and concerns reported in the media" related to the marketing and safety of erythropoiesis stimulating agents. Amgen said Ranking Member Chuck Grassley (R-IA) requested documents and discussion about data requested by the FDA, Amgen's responses to those requests, and other information regarding clinical trials and adverse events. Amgen says it will fully cooperate.

Finally, Amgen said on May 11, a class action shareholder litigation suit was filed against it and several individual defendants alleging "false statements that resulted in a fraudulent scheme and course of business operated as a fraud or deceit on purchasers of Amgen publicly traded securities." It also alleges off-label marketing and failure to disclose negative results of clinical studies. Amgen said in the SEC filing that it had not yet been served with the complaint.

Read more on the SEC Web site.

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