Failure To Implement DTC Guidelines Could Trigger DOJ Scrutiny – Asst. U.S. Attorney
This article was originally published in The Pink Sheet Daily
Inappropriate direct-to-consumer advertising campaigns also expose companies to greater product liability, Assistant U.S. Attorney Meriwether says.
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Independent review panel will be established to handle complaints about pharmaceutical advertising.
“We think our DTC ads are wholly consistent with the philosophy underlying the learned intermediary rule,” General Counsel Frazier says. Merck expects the first Vioxx personal injury trial will commence in the first half of 2005 in either Texas or Alabama.
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications