Vioxx Withdrawal And Drug Safety: Register Now For Audio Conference Nov. 10
This article was originally published in The Pink Sheet Daily
Executive Summary
Office of New Drugs Acting Director Kweder will offer her insights and take questions on what the recall means for the agency's drug safety programs and its impact on industry. She will be joined by Harvard Medical School's Simon and Manning, Selvage & Lee's Pitts.
|
FDA Office of New Drugs Acting Director Sandra Kweder, MD, will discuss the impact of the Vioxx recall on drug safety regulation during an interactive Drug & Device Dialogue audio conference Nov. 10. Entitled "Vioxx: What went right, what went wrong?" the conference will explore how much safety information is enough, both before and after drug approvals, and whether the withdrawal of Merck's COX-2 inhibitor will impact the way the agency balances its objectives of getting important new drugs to market and determining their adverse event profiles. Drug & Device Dialogue is hosted by F-D-C Reports, Inc., publisher of "The Pink Sheet," in partnership with Arlington, Va.-based public affairs firm Polidais LLC. For registration information and further details, visit 1 www.drugdevicedialogue.com or call 800-332-2181. The audio conference will take place from 3 p.m. to 4:30 p.m. EST. Kweder will be joined on the conference panel by Harvard Medical School Associate Professor Lee Simon, MD, who will discuss the research that led to the Vioxx (rofecoxib) withdrawal and current data on the safety of other COX-2s. Simon was director of FDA's Division of Analgesic, Anti-Inflammatory & Ophthalmologic Drug Products from 2001-2003 and also served as a member and acting chair of the agency's Arthritis Advisory Committee. He was one of the senior investigators for the celecoxib development program in the U.S. The mechanics of the recall from a communications standpoint will be dissected by Manning, Selvage & Lee Global Health Director of Health Affairs Peter Pitts. A former FDA associate commissioner for external relations, Pitts also will discuss the potential impact of the Vioxx withdrawal on direct-to-consumer advertising policies. Opponents of DTC advertising are pointing to the Vioxx situation as proof that direct marketing to consumers leads to inappropriate drug use. The flurry of DTC ads by competing Rx and OTC anti-inflammatory drug marketers touting the comparative safety of their products is also raising questions. [Editor's note: For the most current information on this and other events, visit "The Pink Sheet" DAILY's Daybook, updated throughout the day.] - Cathy Kelly |