Waking Up to REMS: Redefining Marketing (Part 3)
This feature first appeared in The RPM Report, September 2009 (Also see "Waking Up to REMS (Part 3): Redefining Marketing" - Pink Sheet, 1 Sep, 2009.).
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The first stage of REMS implementation from March 2008 until December 2009 was relatively easy. FDA and drug sponsors leaqrned how to adapt existing communications programs and techniques to deliver new safety messages. Now both the agency and the sponsors are moving into new territory: evaluating REMS. Both are grappling with the challenge of how to show that programs are working.
FDA's new post-marketing safety authorities place unprecedented burdens on pharmaceutical marketers. But they do something else: redefine a favorite target of industry critics as a regulatory requirement rather than a suspicious activity.
Confidence in the vaccine has slipped in the US, regardless of political affiliation.