Kenneth I. Kaitin, PhD

The US drug regulatory system fails to address the country’s most urgent medical needs with the resources appropriate for the task. But change is possible, say Christopher-Paul Milne and Kenneth I. Kaitin.

For decades, blockbuster product development has driven the pharmaceutical industry. Under that model, a handful of products-and, in some cases, a single product-produce the lion's share of revenue and dictate a company's strategic direction. As companies get larger, they rely more and more on blockbusters to sustain their growth. The high cost of developing major, successful drugs only reinforces the need to focus on blockbusters. It's a vicious cycle that remains firmly in place for most Big Pharma.