FDA's Drug Safety Changes: Safe Legislation; Unsafe Climate
The message from RPM's FDA/CMS Summit Conference: if you want to handicap the effect of the continuing drug safety debate around FDA, you can track the progress of the Kennedy-Enzi bill through Congress - and listen to the tone of the comments from the agency's top managers and its critics. Both will tell you what's at stake for pharma in 2007.
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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.
Overheard at JP Morgan's 25th Health Care Conference: Making Up for Lost Drugs: Pharma Attempts to Appease Investors
The annual JP Morgan conference has always been a stage for reviewing new solutions to the basic business-model problem of biotechnology. But as Big Pharma's troubles have grown, the conference has also become a showcase for large drug company problems. The quick fix: keep shareholders in the stocks by returning cash to them. Medium term: adopt one of four basic business models. Longer term: disaggregate.
The market resurrection of Tysabri demonstrates the power of risk management but raises a tough question: how far can FDA and industry go into the practice of medicine? Biogen Idec declare they are nt trying to tell doctors how to practice. The strict rules of the risk management plan suggest otherwise.