DOAA news in brief

Vet all DTC before it circulates, AZ tells FDA

AstraZeneca has proposed that all direct-to-consumer (DTC) drug adverts should be submitted to the US Food and Drug Administration (FDA) for review prior to use. The Anglo-Swedish company made the recommendation in a letter to the FDAís public hearing on consumer-directed promotion of regulated medical products. The FDA is currently considering revising the rules about safety and risk information prescription drug commercials should include and whether all consumer-directed advertisements must be reviewed before they are circulated. Pharmaceutical companies have recently been the subject of highly critical FDA warning letters with respect to existing promotional campaigns.

Drug promotions examined at FDA hearing

US prescription drug adverts have come under the microscope as US Food and Drug Administration (FDA) hearings over the future of direct-to-consumer (DTC) advertising have got under way. At the hearings, Diana Zuckerman, president of the National Research Center for Women & Families showed several ads for Merckís withdrawn painkiller Vioxx depicting women in idyllic situations. She said the FDA should consider regulating image selection "because imagery can be as powerful as any wording". Several speakers attacked off-label promotions of antidepressants. Peter Lurie of health advocacy group Public Citizen showed the 11-member panel an internet-based promotion for the acne drug Differin that promised teenagers free music downloads in exchange for signing up at the website, and for getting a prescription and refilling it.