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.
Alan Goldhammer, PhD, is vice-president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA),