The subpoena, issued from the New York state attorney general on May 10, sought documents relating to marketing activities, medical education and clinical studies, Amgen said. The company, which markets the erythropoiesis stimulating agent (ESA) Aranesp, added that it intended to fully cooperate with the subpoena.
Amgen also said in the filing that it had received a letter from the US Senate Committee on Finance requesting a briefing to discuss the issues and concerns reported in the media as to the marketing and safety of ESAs. The committee was interested in data requested by the FDA, Amgen’s response, any trials that have been terminated due to adverse effects, and what the company has done to inform doctors and patients of the risks surrounding the use of ESAs.
The use of ESAs, which are approved to treat certain patient groups with anemia, has been under the spotlight recently following reports of adverse effects. The FDA has subsequently warned doctors and patients not to use ESA drugs in higher doses than approved.