The Safety of Food and Drug Imports
February 6, 2010
After her first eight months as Commissioner of the U.S. Food and Drug Administration (FDA), Margaret Hamburg, M.D. came to CSIS yesterday to discuss the current state of food and drug safety, the need for ‘massive change’ within the global regulatory framework, and announced a new FDA program. A panel following Dr. Hamburg’s keynote address brought together perspectives from private industry, former government officials and experts on trade to discuss the FDA’s new initiatives. This panel featured Commissioner Hamburg; J. Stephen Morrison, Director of CSIS’s Global Health Policy Center; Reuben Jeffry III, Senior Advisor, CSIS President’s Office; Thomas Bollyky, visiting fellow at the Center for Global Development; and Henry Chin, M.D., of the Coca-Cola Company.
The FDA is the federal agency responsible for the safety, security, and efficacy of human and veterinarian drugs, food supply, medical devices, cosmetics, and most recently tobacco, to name a few of the agencies responsibilities. In her address, Dr. Hamburg emphasized that the traditional approach to regulation needs a ‘significant overhaul’. In order to truly protect Americans from unsafe food and drugs in the 21st century, the FDA needs to change from a reactive to a proactive agency, and efforts should be made towards creating accountability and cooperation within a new collective global supply chain; creating benefits not only for the U.S., but for global health as well.
Dr. Hamburg noted that within the current FDA system, less than one percent of the 20 million FDA-regulated imports are inspected each year. The FDA is responsible for regulating food products imported from more than 150 countries, which come from more than 300,000 foreign facilities and its mission to protect Americans from unsafe food and drug products is increasingly difficult. While many factors add to this reality, that there has been little systematic change to the FDA, as rapid globalization has created complex food and drug supply chains which cross through developing and developed countries alike. As Dr. Hamburg said, “Today the FDA faces a daunting set of tasks. Globalization has multiplied the scale of our responsibility, and the challenges we face.”
In order to compete with counterfeit drugs, terrorists looking to do harm, and unintentional side effects such as food additives, filth and faulty or diseased products, Dr. Hamburg announced the new FDA system PREDICT, showing a video on how it will work. This risk-based screening system will assists in alerting FDA reviewers to target products which are highest-risk, and allows lower-risk products to go through the screening process more efficiently. To hear more about this new system from Commissioner Hamburg, you can listen to this CSIS podcast.
Other priorities which Dr. Hamburg noted to create a stronger, more proactive FDA included: better controls at point of production, locating FDA officers in foreign countries, building and strengthening bilateral and multilateral regulating agreements with countries; holding importing companies responsible for their supply chain, setting best practices, enforcing penalties and incentives for companies based on compliance; and deploying FDA resources strategically to ensure that money is spent effectively and efficiently.
The paradigm shift Dr. Hamburg outlined is one she noted will be difficult in this time of economic crises, needing the support of our international partners, private stakeholders and Congress. The panelists who represented various important sectors gave their insight on how partnerships can be bridged, and reinforced the need for a 21st century approach to food and drug safety. Tom Bollyky, who wrote a CSIS report on this subject, reinforced and emphasized Dr. Hamburg’s call for a new strategic framework for food and drug safety and that the FDA cannot create safe supply chains on its own, and that the effects are globally beneficial. Reuben Jeffry III, former undersecretary for economic, energy and agricultural affairs at the Department of State, stressed the need to incorporate other federal agencies such as Department of Agriculture and Office of the U.S. Trade Representative into discussions on food and drug safety; the need to leverage existing forums such as the G-8 or G-20 for multilateral cooperation; and the importance to look at what implications new policies would have on underdeveloped nations where regulation is much more difficult and expensive. Dr. Henry Chin of Coca-Cola, highlighted that many of the changes FDA is pursuing are transformations the private industry put into affect many years ago, as it is socially responsible and in the best interest of businesses as well. Dr. Chin said he would be happy to share best practices with the FDA, and noted that a difficulty that private industry faces, which the FDA does as well is harmonizing regulations from one country to another. Moderator, J. Stephen Morrison pushed the panelists to look at what success would look like five to ten years down the road, and to suggest which forums would be most appropriate for leveraging international participation.
“And I think the overall message that I hope to convey is that FDA is a critical player, domestically and internationally” ended Dr. Hamburg, “in promoting and protecting the health of the public, and that in order to do so, we need to be adequately supported, we need the appropriate authorities, we need to be in a position to truly leverage science and technology and we need to work in full partnership.”
Read the transcript to the event here. A full video of this event is forthcoming.
Special thanks to Elizabeth Morehouse for this article.