Congress is gearing up yet another investigation of consumer drug advertising.
The House Committee on Energy and Commerce requested documents from Amgen and Johnson & Johnson pertaining to the promotion of anemia drugs.
The documents requested include records relating to DTC, print and TV ads, contracts with physicians and information related to marketing dollars.
Both letters cite “disturbing safety issues in connection with a class of drugs known as Erythropoiesis-Stimulating Agents (ESAs), which are designed to prevent the need for blood transfusions in cancer and dialysis patients suffering from anemia.”
The committee, led by chairman John Dingell (D-MI), asked J&J to provide information on Procrit, stating concern that “J&J may have used misleading DTC television and print advertisements…to help fuel excessive and dangerous off-label use of the drug, particularly in connection with unsubstantiated ‘quality of life' claims.”
Amgen has not marketed its anemia products (Epogen and Aranesp) DTC, but the committee asked the company to provide Aranesp rebate info. The committee letter suggests that bundling practices have “helped fuel excessive and dangerous off-label use of Aranesp.”
“While Amgen does not believe [drug rebates] have led to inappropriate or excessive off-label use of ESAs, to avoid even the appearance of such concerns, earlier this year, Amgen restructured the rebates of its Aranesp contracts to be based on share of sales rather than sales volume,” says Amgen spokesperson Ashleigh Koss.