Avandia and the Commercial Impact of FDA's Credibility Gap
GlaxoSmithKline's diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA's credibility.
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If there's a theme to many of the top pharmaceutical stories of 2007 it's infrastructure: the crisis of owning too much infrastructure when R&D productivity is at its lowest level since 1983, and the economic power of leveraging someone else's. That's the connection, for example, between: Bristol-Myers "selective integration" strategy and its huge partnering deals with Pfizer and AstraZeneca; the rise of biopharma-focused private equity; the investment boom in China; the emerging strategies focused on reaping value from proof-of-concept development; even the now customary twin-tracking of the IPO/M&A process. Other key events for 2007 that will re-shape the playing field for 2008: the new role of CMS as a partner with FDA in the regulatory process; the continuing importance of large molecules and discovery platforms to Big Pharma; and the strategic restructuring of spec pharma.
FDA is trying to get safety messages out to consumers more rapidly. A recent warning on Nexium and Prilosec shows how complicated these early warnings can be.
A preview of the emerging health care companies profiled in the current, all-profiles issue of Start-Up. This month's profile groups are "Start-Ups in Obesity," "New Technologies for Infertility," and "New Zealand Biotech." Plus these Start-Ups Across Health Care: Intelect Medical, N Spine, and Solace Pharmaceuticals.