March: Biodefense & food supply safetyFDA needs to move with the times

Published 6 March 2008

The FDA tasks and responsibilities grow as its budget and resources are cut; FDA commissioner says agency needs to adapt to changing safety concerns and technological advances in both industries

The Food and Drug Administration (FDA) needs to adapt to changing safety concerns and technological advances in both industries, said a representative last week. Andrew von Eschenbach, commissioner of food and drugs at the FDA, explained that the body must reform to meet the new challenges posed by the globalization of food. “Urbanization has given way to globalization, and the industrial age now embraces the information age,” von Eschenbach said. “As with the past these changes are filled with promise but also peril as they impact on our health. Society must respond and, I believe, recreate the FDA.” He used new safety issues as examples of new challenges facing the FDA, such as the risk of botulism in canned chili sauce and E.coli and salmonella contamination in ready-to-eat fresh cut produce. This represents an area of importance that the FDA must focus on. Other areas are food protection, drug safety, the scientific foundation for regulatory decisions, work force development and essential infrastructure. Only in December, a year-long review entitled the Report of the Subcommittee on Science and Technology said the FDA failed to support new technologies or to ensure food safety as a result of being under-funded and under-resourced.

Von Eschenbach said collaboration with the food and drug industry and with government will help the FDA carry out systematic and systemic change to successfully carry out its intended functions. He said that “It is no secret in Washington that as the FDA’s responsibilities have grown, the resources devoted to them have not kept pace. Strengthening the FDA for this new century will require an investment, providing our agency with a budget and authorities that are commensurate with the scale and scope of our mission.” The food commissioner said the FDA must develop a disciplined process for assessment of the problem to obtain the information necessary for devising the appropriate intervention.

Furthermore, it plans to increase its workforce by 700 new employees in 2008, improving its resources in the hope of successfully carrying out its functions. This was primarily made possible by the passage of the FDA Amendments Act of 2007. He also said the FDA must improve on its monitoring and detection strategies, but enhancing its response to lessen adverse outcomes. Von Eschenbach referred to a new program to be introduced called the Sentinel Initiative. It will be a collaborative effort with public and private partners to create a distributed, nation-wide system that will allow FDA to analyze large databases of information about the safety of medical products as they are used by diverse populations. He said: “This emphasizes the need for FDA to enhance its collaborations. We are forging multiple partnerships with Federal agencies like Customs and Border Protection, the Centers for Disease Control and Prevention, and the US Department of Agriculture, as well as State agriculture and health colleagues, private sector organizations, and our international counterparts.”

Therefore, the FDA needs to continue to get its budget increases, he said. Its federal budget request for 2008 totaled $2.1 billion, a $105.8 million increase from 2007. Additionally, he said greater authority was needed from Congress to better regulate the food supply. It has developed a Food Protection Plan, which calls for ten new legislative authorities. Von Eschenbach called on Congress to grant those new authorities by Memorial Day. He said: “I will continue to make my staff available day or night to work with Congress on these important initiatives-we need this legislation.” From the industries, he asked for strong corporate responsibility and compliance with regulatory standards as well continued support of the user fee programs with amounts appropriate for the services rendered. And from the public, he said the FDA is looking for support and patience, as well as trust and confidence in our work.