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President Obama's choice for agency leadership should take into account several factors.
The Pharmaceutical Research and Manufacturers of America (PhRMA) looks forward to President Barack Obama's expeditious selection of a future leader for the US Food and Drug Administration. Because of the vital nature of FDA's public health oversight, identifying a strong, independent FDA Commissioner should be among the first accomplishments of the new administration.
In recent years, FDA has been buffeted by a series of leadership changes. Stable FDA leadership befits this integral agency, helps ensure public health, empowers its talented staff, and inspires confidence in its scientific and regulatory decision-making. As President Obama narrows a talented list of potential commissioners, he should keep a few defining strengths in mind.
Management style. The ideal candidate must be resilient and independent to support a strong, autonomous, and science-based agency. The new commissioner also must have strong managerial skills, essential for directing science-based activities at an agency that is in the process of expanding its ranks with hundreds of new employees. Managerial skills will be particularly important in an agency that is striving to implement groundbreaking reforms to better position itself to tackle future challenges, including modernizing FDA methods for evaluating safety and efficacy throughout a product's life cycle.
New regulatory controls. FDA continues to implement new authorities, granted in 2007, to help ensure drug safety after marketing. The agency has quickly embraced its enhanced postmarketing authorities, calling for mandatory distribution of consumer medication guides and mandatory postmarketing clinical trials. FDA also has mandated new Risk Evaluation and Mitigation Strategies, which can enhance the communication of drug risks with patients and healthcare professionals. These new authorities—each critical to enhancing drug safety—require effective management going forward.
The agency regulates products that account for one quarter of every dollar spent by consumers in the US. It is unreasonable to expect the commissioner to possess the vast knowledge of science, toxicology, microbiology, and biotechnology needed to evaluate FDA's entire regulatory portfolio. Instead, FDA staff is akin to a public corporation and the commissioner a chief executive officer, adeptly managing employees' skills and providing a unifying vision, while retaining the ability to tackle the agency's thorniest decision-making. The commissioner will need the foresight to devise a coordinated and coherent management plan that integrates personnel and resources.
As the agency manages new resources and authorities, it must continue to reasonably assess benefits as well as risks, understanding that careful balance assures patients prompt access to promising new medicines. At a time when it might take up to $1.3 billion to develop a new medicine and $1.2 billion to bring a biologic to market, the agency must strive for a streamlined regulatory pathway that is transparent, efficient, rational, and science-based, without sacrificing rigor.
Outside partnerships and advisors. An important avenue for FDA to gain input from outside researchers and the public is through its advisory committees. New legislation aims to improve the transparency of the these committees and their membership. The new commissioner must retain FDA's focus on this important matter and facilitate the efficient use of outside experts.
Resources and risk. In the fall of 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA), which strengthened the agency's ability to protect and preserve public health. The measure significantly increased user fees to provide FDA the resources necessary to improve and modernize its already strong drug-safety system. The agency will be able to enhance its use of epidemiology studies and large medical databases as a result. In addition, the agency already is modernizing its Adverse Events Reporting System with the aim of better evaluating risk- communication and risk-management programs. It will be important for the new commissioner to implement these tools carefully and in cooperation with all stakeholders.
PhRMA supports enhanced tools and resources to help identify emerging safety risks. For example, the association supported the creation of new public–private partnerships authorized by FDAAA. These partnerships will help to craft the pharmacovigilance system of the 21st century.
FDA's Sentinel initiative is one such important partnership. Industry officials, academics, and government researchers will work side-by-side to develop a new electronic system that will enable agency officials to survey a broad array of data to identify possible drug side effects. This active surveillance program should improve the efficiency of postmarket surveillance of medicines and, ultimately, benefit the millions of patients using these products.
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), AGoldhammer@phrma.org