With hurricane season at its peak, one might wonder, “What will the prevailing winds bring to the pharmaceutical, biotech and medical device industries, and how can manufacturers weather the storms?”
In recent years, three major trends have emerged:
• A decreasing number of FDA approvals (only 13 new molecular entities or new combination approvals in the first seven months of 2008).
• An increased focus on comparative effectiveness, as evidenced recently by legislation introduced to establish a private, non-profit institute to examine and generate evidence on treatments that achieve the best clinical outcome for patients (Comparative Effectiveness Research Act of 2008).
• Large reductions (20%+) in pharmaceutical manufacturer sales forces in favor of smaller, targeted field teams focused on payers.
With these major shifts, a solid payer value proposition for both
new and marketed products is…