[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.
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