26 Mar Fast Track: Topics for Consideration
The Food and Drug Administration is changing. However, is it evolving to better serve its customers? I believe the answer is a qualified “yes”, but the demands on the agency are growing while its resources are not. The growing demands of scientific discovery, regulatory needs, and competitive economic interests consume a lot of resources at FDA.
The explosion in biotechnology and other scientific discoveries is creating a tremendous strain on the technical and scientific capabilities of the agency. One reason for this strain is the frequent mismatch between FDA expertise and new product development. Another reason is that FDA reviewers often are isolated from new scientific and technical developments and therefore necessarily review current applications in the context of previously reviewed applications rather than in an innovative scientific framework. Also, some FDA staff are quite current in their scientific niches but others are decades behind. Finally, appropriate intellectual resources in the agency sometimes are not brought to bear on a particular product application because knowledge and information do not flow readily within the agency. In the next issue I will focus on user fees and some of the initiatives of Dr. McClellan, the FDA Commissioner, that may relieve some of these problems.
Enforcement and regulatory demands on the agency are growing in response to the public’s high expectations that FDA will protect them from every health risk or fraud. One example is the ephedra problem that forced FDA to propose labeling and manufacturing regulations for all dietary supplements and could even lead to premarket review of the products by the agency. Another example is FDA’s proposed registration requirements for food facilities and for prior notice of food imports in response to concerns about bioterroism. Of course, FDA spends considerable resources reviewing advertising and labeling of many products. I will talk about these issues in later columns.
Finally, competitive economic interests currently consume considerable resources at FDA and these demands are likely to grow. One example is FDA’s role in patent term extension. Another is the agency’s effort to control prescription drugs importation from Canada; FDA has threatened civil and criminal penalties for these importers.
FDA has many customers with diverse, and often, opposing expectations: inventors, manufacturers, research organizations, and consumers. Go fast; go slow! Be risk-averse; be innovative! Restrict commercial speech; allow free flow of information! Be controlling; be open!
Will FDA evolve successfully to meet new scientific, enforcement, and economic roles? Stay tuned!
Morris Waxler leads the FDA Consulting Practice at LaFollette, Godfrey & Kahn. His understanding of FDA policies, procedures, and processes are grounded in his 26 years as a successful scientist and manager at FDA and 2 years as a Regulatory Affairs Specialist with the Washington, D.C. law firm of Hogan & Hartson, L.L.P. Morris will provide periodic insights on the FDA to the Wisconsin Technology Network.
The opinions expressed herein or statements made in the above column are solely those of the author, & do not necessarily reflect the views of Wisconsin Technology Network, LLC. (WTN). WTN, LLC accepts no legal liability or responsibility for any claims made or opinions expressed herein.