[Posted on behalf of Jeffrey Skopek, Academic Fellow, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration (for now – and soon headed off to Mylan), gave a keynote address exploring the ways in which the FDA’s mandate is increasingly difficult to achieve in an era of globalization.
In the first part of the talk, she provided an overview of the FDA, discussing the extent to which FDA-regulated products infuse nearly every aspect of life. For example, 20 cents of every consumer dollar spend in the US is on a good that is regulated by the FDA (for a total of over 2 trillion dollars). Further, the FDA must achieve this monumental task at very lost cost to the public – just 8 dollars per person per year.
The second part of the talk identified various ways in which modernization (e.g., the speed of technology, communications, and commerce) and globalization (e.g., the complex global regulatory landscape) is making the FDA’s mandate more difficult. Just as disease knows no borders, product safety and quality no longer know any borders. For example, FDA regulated products originate from more than 150 countries, 130,000 importers, and 300, 000 foreign facilities. And the number of FDA regulated shipments at over 300 ports has skyrocketed. For example, 10-15% of food products are imported, 50% of medical devices are imported, and 40% of drugs are imported. Further, the global supply chains are complex and hard to oversee, in part because the increased number of individuals, producers, and companies are geographically dispersed; and also because the new and hard to regulate distribution channel for products, such as the internet.
The third part of the talk identified the actions that FDA is taking to deal with these challenges and strengthen the global product safety net. The first is the establishment of foreign posts that help FDA understand what is happening abroad; establish contacts with counter-parts; and conduct foreign inspections (which have increased 186% since 2008, to 2706 inspections in 2012). The second is improved technology, including the deployment of the PREDICT system at the border and a hand-held device known as CD3 that can be used to detect counterfeit drugs and packaging in the field. The third is the development of multi-lateral and bilateral relationships (over 30 arrangements with foreign counterparts) that are conducting joint inspections, working to harmonize and set standards, and conducting training with counterpart agencies to increase understanding of FDA regulations. The fourth is the strengthening of regulatory systems abroad, as it is much better to have countries controlling what happens within their own borders, rather than to have FDA trying to control things from outside.
The fourth part of the talk identified the actions that the FDA should take going forward. To do so, FDA formed a Globalization Steering Committee, a cross-section of agency experts tasked with developing a framework and action plan to guide the future regulation of FDA imported products, and addressing globalization challenges 10 years down the road, as well as those of today. It identified several core pillars. The first is to partner with foreign counterparts to create a global coalitions of regulators. The second is to build global data information systems. The third is to expand intelligence gathering with an increased focus on risk analytics (e.g., identify signals of potential risks before they occur; determine how to monitor those signals; enhance risk analytics capabilities; and build a supporting infrastructure that enables experts to readily access and analyze data). The fourth is to effectively allocate agency resources based on risk, and leverage third parties (e.g., use intelligence to align and deploy resources more effectively; allow FDA to maintain broad-based oversight but enlist others to conduct audits and activities on behalf of FDA; create flexibility to shift resources to the most pressing dangers; and treat like risks in equivalent ways, regardless of geographic location). More generally, in developing this global coalition of regulators, we must maintain and respect foreign state sovereignty by relying on common science based standards; focusing on comparability, not equivalence; and learning from other operating and governance models.
In conclusion, she highlighted that the FDA cannot solve these challenges alone—that there is a role for industry (which must take full accountability), consumers (who must be informed), and other regulators, organizations and associations (who must all work together). Only in this way will we be able to ensure that safety and quality no longer begin and end at the border.
In the Q&A, Jeffrey Senger inquired about the relationship between law and public health, asking whether the legal standard for action should be different from the public health standard, and whether the law should be an excuse to do nothing. Autor replied that there can be a bias for inaction; that we should sometimes have a bias for action, as there are often more options for action than the lawyers at first recognize; and that in general, we need to be more balanced. Holly Lynch then asked whether clinical trials, where industry has relied on private contractors to do international inspections, can provide a model for the FDA. Autor responded that the FDA needs to use more third parties, but needs to make sure it has a system to check the checkers. A third participant asked about two bills that have been introduced in Congress to introduce track and trace systems, asking what she thought about the chance of passage, and what her thoughts were on the potential conflicts with other states/nations that are developing their own systems. Autor responded that she thinks that chance for passage is good, in part because California is implementing a system, which is creating momentum to get a federal standard.
