Qualities in a nutshell. Overall, new FDA leadership will be tasked with deftly implementing recently granted authorities, and prioritizing the allocation of bolstered Congressional appropriations and enhanced user fees paid by America's pharmaceutical research and biotechnology companies. The new commissioner will need to work with diverse partners, including researchers, Congress, the White House, patients and pharmaceutical research companies on such measures as the Critical Path Initiative, which improves the scientific bases for product development and manufacture.

Without question, user fees have helped to provide FDA with the essential tools and staffing it needs to protect and promote the public health. However, like Congressional leaders and the White House, PhRMA recognizes the consequences of the agency's insufficient funding. A strong, well-funded FDA is critical to the health and safety of the American public. The incoming FDA commissioner should embrace the need to advocate for an empowered, fully-funded FDA, with a willingness to request additional Congressional resources and authorities, as needed.

The Reagan-Udall Foundation, for example, provides an important place for industry and regulators to work together on mutually beneficial goals such as improving science, streamlining drug approvals, and leveraging industry experience with cutting-edge research tools. While the research foundation has begun its work through private funding, congressional appropriations are needed for it to fulfill its true promise. Through such efforts, FDA and its new commissioner have the potential to follow the lead of the National Institutes of Health, charting the path and leading important public–private partnerships that help patients live longer, healthier, and more productive lives.