FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

FDA Voice Interviews Deborah M. Autor, Esq.

En Espanol

FDA Voice: Thanks for agreeing to talk with us – can you tell us a little about your job at FDA?

Deputy Commissioner Autor: My goal is to make FDA’s response to globalization challenges and import safety a top priority. A little bit of background – last July 2011, Commissioner Hamburg established the Office of Global Regulatory Operations and Policy (“GO” or “Global Operations”) as one of FDA’s new Directorates. This office provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product efforts. I provide broad direction and support to the Offices of Regulatory Affairs and International Programs and I also work on making sure FDA integrates its domestic and international programs to promote and protect public health.

Deborah M. Autor, Esq.FDA Voice: What brought you to GO?

Deputy Commissioner Autor:  There have been fundamental global shifts that have major implications for consumers – and transforming FDA from a domestically focused agency operating in a globalized economy to a truly globally focused public health agency that oversees a worldwide enterprise is a now both a necessity and monumental challenge. Given my almost twenty years of professional experience working on issues related to FDA-regulated products, when Commissioner Hamburg offered me this opportunity to lead GO and help with transforming FDA into a modern public health regulator in a globalized economy, I welcomed the opportunity.

FDA Voice: Tell us more about what you were doing before GO.

Deputy Commissioner Autor: I joined FDA in 2001, and from 2006 to 2011, I served as Director of the Office of Compliance at CDER. Before that, I was a trial attorney at the U.S. Department of Justice, Office of Consumer Litigation, and in private legal practice before that. So pretty much my entire professional career has been focused on FDA-related issues.

FDA Voice: What’s the favorite part of your job at FDA?

Deputy Commissioner Autor: By far, the favorite part of my job is working with the passionate and dedicated people at FDA. They exemplify the best in public service and it’s a privilege to work collaboratively with such great people on critical public health issues.

FDA Voice: What major changes have you witnessed in FDA over the past ten years?

Deputy Commissioner Autor: Global economic conditions and innovations in technology, science, and communications have dramatically changed the landscape of FDA regulated products and, in addition, global production of FDA-regulated goods and materials has exploded over the past 10 years. For example, FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities. In 2011, nearly 24 million shipments of food, devices, drugs, cosmetics, radiation-emitting products, and tobacco products arrived at U.S. ports of entry. Ten years ago, that number was closer to 6 million. So you can see how globalization has fundamentally changed the economic landscape in the U.S., and it will continue to have major implications for FDA.

FDA Voice: How can we meet the challenges of globalization?

Deputy Commissioner Autor: We have come up with a plan, and last June, 2011, we published a special report, “Pathway to Global Product Safety and Quality,” which lays out our global strategy and action plan. I hope people will read the plan, but in short it lays out an approach focusing on four pillars of: building global coalitions of regulators; establishing global information sharing and networks; increasing intelligence-gathering and risk analytics; and, leveraging third parties. The Pathway focuses on how FDA, given its limited resources, can have the greatest impact on public health–a goal we all share.

FDA Voice: How do you envision FDA ten years from now? 

Deputy Commissioner Autor: Our goal for the future is to build a public health safety net for consumers around the world, created, supported, and maintained by global coalitions of regulators. In the future, we will be operating under a model that relies on strengthened collaboration with other regulators, improved information sharing and gathering, data-driven risk analytics, and the smart allocation of resources, leveraging the combined efforts of government, industry, and public- and private-sector third parties. It is clear that FDA, and our many partners, are ready to face the global challenge together!

FDA Voice: Thank you so much for your time!

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy