The FDA must be “a consistent catalyst for innovation,” insisted FDA commissioner Margaret Hamburg, M.D., in a July 13 letter to colleagues. That determination couldn’t come at a more critical time.
The scientific, logistical, and administrative challenges are significant. “Innovative products that are truly transformative create unique scientific and regulatory challenges,” Dr. Hamburg acknowledged. The food, drug, and cosmetic industries have a global reach and a global supply chain, with international regulatory hurdles. Administratively, the FDA faces the challenges of any large organization—providing the resources and training necessary to keep its staff of 12,000 performing at peak efficiency.
Following the April release of its Strategic Priorities 2011–2015 document, the FDA has released several proposals to streamline drug testing, nanotechnology, and low-risk diagnostics, as well as draft companion diagnostics guidance, in an attempt to increase regulatory uncertainty and the speed and accuracy of reviews.
But, as Dr. Hamburg recently wrote to colleagues, “The most obvious change is that the Agency’s programs will be divided into directorates that reflect the core functions and responsibilities of the Agency.” Her goal is to better support core functions and to link programs that share common regulatory and scientific foundations. The seven existing centers, she emphasized, will remain under their current leadership.
To enhance consistency, the position of Deputy Commissioner for Medical Products and Tobacco is being established to oversee the “Special Medical” programs and to provide “high-level coordination and leadership” across the seven centers. The FDA is also establishing the Directorate of Global Regulatory Operations and Policy, to move the FDA from “an organization regulating domestic products to one overseeing a worldwide enterprise.”
The Office of the Chief Scientist will continue its efforts to “improve FDA’s science and address issues of cross-cutting scientific concern.” The National Center for Toxicological Research will report to this office. The FDA is also forming the Office of Foods to implement the Food Safety Modernization Act, and the Office of Operations to oversee administrative functions, including information technology and finance.
This implementation shares some commonalities with the improvements proposed by BIO CEO Jim Greenwood in his keynote speech at this year’s BIO International convention in Washington, D.C. There, he advocated establishing the FDA as an independent agency, updating its mission statement to create a clear mandate to encourage the development of innovative products, creating a chief innovation officer, and developing a progressive approval pathway.