Manhattan Moment: Renewing user-fee program will boost innovation, FDA performance

Is America still a place where big ideas can move policymakers to slash red tape in drug development to save lives, drive innovation, and spur economic growth? It certainly appears so. The Obama administration, industry, the Food and Drug Administration and patients’ groups have all come together in recent months to highlight the need for regulatory reforms to help patients gain faster access to safer and more innovative medicines.

Streamlining innovation begins with improving the FDA’s framework for evaluating the potential risks and benefits of new medicines — and making it as transparent, predictable and science-based as possible.