The worlds number one biotechnology group Amgen has been issued a subpoena by the New York state attorney general asking for documents regarding certain sales and marketing practices and promotional activities.
In a filing with the US Securities and Exchange Commission, the group said it has received the subpoena on May 10, which also asked for information on medical education, clinical studies, pricing and contracting, license and distribution agreements and corporate communications. Further details were not given, but the group said it intends to fully cooperate in its response.
Amgen also said it had received a letter from the US Senate Finance Committee on May 16 requesting a briefing to discuss the issues and concerns reported in the media related to the marketing and safety of its erythropoiesis-stimulating anaemia drugs Aranesp (darbepoetin alfa) and Epogen (epoetin alfa).
Senator Grassley has requested documents and discussion around whether the company: provided complete responses to FDA data requests; sponsored ESA trials that have been terminated, suspended, or otherwise not completed that showed evidence of serious adverse effects; informed the FDA of studies related to the use of Aranesp and Epogen to improve a patient’s quality of life; and what actions Amgen has taken to ensure that doctors and patients are informed of the new safety risks surrounding ESAs. Again, the group said it will cooperate fully with these requests.
Stronger warning for ESAs
Earlier this month, shares in both Amgen and Johnson & Johnson took a hit after an advisory committee of the US Food and Drug Administration recommended further marketing authorisation of Aranesp and Epogen and J&J's Procrit (epoetin alfa) be contingent upon adding additional restrictions to the drugs’ labels. The panel also voted 17-0 that the companies need to conduct additional clinical trials of the drugs to demonstrate their safety.
The committee's view came as no surprise given that the FDA recently said that new safety and dosage information needs to be put on the labels of Aranesp, Epogen and Procrit.
The new warnings advise physicians to monitor red blood cell levels and to adjust the ESA dose to maintain the lowest haemoglobin level needed to avoid the need for blood transfusions and physicians and patients are being warned to carefully weigh the risks of these products against transfusion risks.