House Committee Calls On EPO Marketers To Provide Information, Halt DTC Ads
This article was originally published in The Pink Sheet Daily
Executive Summary
Inquiry also requests Amgen and Johnson & Johnson cease financial incentives to physicians.
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The House Committee on Energy and Commerce is requesting that erythropoietin marketers Amgen and Johnson & Johnson cease direct-to-consumer advertising for their anemia products, stop providing financial incentives to physicians to increase prescriptions and provide additional information about the safety and marketing of the drugs. Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., issued letters to the two drug makers March 20 calling on them to cease DTC advertising for the products until after FDA's Oncologic Drugs Advisory Committee meets May 10 to discuss the safety of the product and FDA has had time to complete a safety review. The inquiry stems from the emergence of new data about the effect of aggressive dosing of EPO products on mortality. FDA issued a public health advisory March 9 announcing the addition of a "black box" warning for EPO products alerting physicians to use the lowest dose of the products (1 (Also see "EPO Aggressive Dosing May Be Curtailed By New Black Box Warning" - Pink Sheet, 9 Mar, 2007.)). "Clearly off-label use of these dangerous drugs must be halted, and that will not happen until the direct-to-consumer advertising is suspended and the financial incentives to physicians are curtailed," Rep. Dingell said in a statement. In the letters to the two drug makers, the lawmakers estimate that as much as $700 million in annual sales of EPO products come from off-label uses. However, Amgen, the marketer of Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), told "The Pink Sheet" DAILY that it has never used DTC advertising to promote either product. In addition, "Amgen does not give financial incentives to physicians," the company said. "Amgen will fully cooperate with the committee inquiry and looks forward to sharing the requested information regarding our medicines," the firm added. J&J, which markets Procrit (epoetin alfa), said it has not advertised the drug to consumers since 2005. "When we did run consumer advertising, our ads did not promote off-label uses and were consistent with the product label at the time the claims were made," J&J said. Similarly, the company said it does not provide financial incentives to physicians to prescribe drugs including Procrit. "We are in receipt of the letter from the committee chairman and will cooperate with the committee's request for information," J&J added. "We are in the process of discussing the specific questions raised in the letter." The House committee is also requesting that Amgen and J&J answer several questions related to EPO products, such as when the companies learned of the suspension of any EPO study halted out of concern for safety; when FDA was notified of the suspensions; and descriptions of conversations the companies have had with FDA related to DTC ads since the agency was advised of the adverse events included in the black box warning. J&J and Amgen were invited to participate in the ODAC meeting to review the effects of EPO on survival in February (2 (Also see "Boxed Warning In Development For Procrit, Aranesp" - Pink Sheet, 1 Mar, 2007.) -Jessica Merrill ([email protected]) |