Senate committee seeks further ESA rebate informationA second congressional committee is seeking answers from Amgen about rebate practices related to its anemia drug Aranesp, an erythropoiesis-stimulating agent (ESA).
In a letter sent to Amgen on April 3, Sen. Chuck Grassley (R-IA), a ranking member of the US Senate Committee on Finance, requested “a discussion of the factors that are considered in determining the rebates/discounts Amgen pays to physicians, group practices, and physician clinics.” Specific questions and clarifications for Amgen mentioned in the letter include a “description of any factors specific to individual states that may impact Amgen's rebate/discount calculations,” and if “rebates/discounts take into account the purchase of another drug and/or other product(s) from Amgen or are rebates related to amounts purchased in certain time frames?”
The US Senate Committee on Finance has jurisdiction over Medicare and Medicaid programs, and therefore “has a responsibility to the more than 80 million Americans who receive health care coverage under those programs...to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices,” the letter states. Recent safety concerns surrounding ESAs led an FDA advisory committee to recommend a more limited use of the drug class in March. Grassley queried the FDA last May about the safety of ESAs and the availability of clinical information used to assess potential dangers.
Grassley's letter follows a similar request from the House Committee on Energy and Commerce, led by chairman John Dingell (D-MI), seeking company records associated with possible discounts offered to physicians on two other Amgen products, Neupogen and Neulasta, in return for prescribing Aranesp. The House Committee also requested DTC advertising records and copies of print and television ad creative.