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  1. FDA Voices

Reflections on Travel to Europe – Part Three

Photo collage - Background image of European Union flag. Top photo - exterior of European Medicines Agency (EMA) headquarters in Amsterdam. Bottom photo - interior of EMA headquarters.

By: Robert M. Califf, M.D., Commissioner of Food and Drugs

This trip finally gave me a chance to take my first train ride through the Chunnel—frankly, it was disappointing as it was already dark so there was no view going into the tunnel and there is no view at any time of the day under the ocean! The good news is that we were traveling with FDA colleagues—a real treat.

Robert M. Califf, M.D.
Robert M. Califf, M.D.

After a good night’s sleep, we visited the U.S. Mission to the European Union (EU) in Brussels, an important historic focus for the U.S.-Europe relationship. Brussels has always had a particular significance to me because my dad was in the Battle of the Bulge, centered not far from Brussels, and he was saved from capture by Belgian people in the countryside.

We visited Ambassador Gitenstein, the U.S. Ambassador to the EU, and got a useful briefing from the mission staff representing the variety of U.S. Government agencies with posts in Brussels. The stress levels are high with the war continuing in the Ukraine coupled with issues in the Middle East. The intertwining of public health and the business of food, medical products and healthcare delivery gave us plenty to talk about concerning the synergies and tension between protecting health and international trade as a key element of the economy. I was honored to spend time with our staff in Brussels—what a complex and interesting job representing the many aspects of the FDA in a complex multinational environment.

Carlos Goncalo das Neves, Chief Scientist of the European Food Safety Authority (EFSA) came to visit us and we had a virtual session with EFSA’s leadership, including Executive Director Bernhard Url. It was not surprising to learn that they are watching our proposed foods program reorganization closely and share aspirations to use better data, genomics and risk-based analytics to drive a safer food supply. There is also a growing scientific interest in the issue of ultraprocessed food and its impact on health. Jim Jones, the FDA’s Deputy Commissioner for Human Foods, Don Prater, D.V.M., the FDA’s Acting Director, Center for Food Safety and Applied Nutrition and our FDA team joined the EFSA call, giving me a chance to call out Don for his previous service in the Brussels post.

Our visit to the European Commission (EC) yielded a rich discussion ranging from food safety and nutrition to the difficulties encountered implementing the new EU medical device regulations, to generic drug shortages. The EC’s Directorate-General SANTE is the Directorate responsible for food safety and health, led by Stella Kyriakides with a competent and focused staff. The complexity of coming up with consensus on regulation in the EU was impressive, but the Commissioner and her staff were focused on many of the same issues that concern us.

We had a nice train ride from Brussels to Amsterdam (the trains in Europe are impressive!) and quickly went to work across the street from the hotel at the beautiful European Medicines Agency (EMA) headquarters.

We connected on a range of common issues with the EMA. As it relates to drugs and biologics, the benefits of broader collaboration were clear in areas like rare disease and cell therapy treatment, combination products, clinical trial methods and real-world evidence. We also shared concern and intent to develop strategy to deal with the pervasive influence of misinformation on the health of our populations and the need to bolster confidence in public institutions. Improving the resiliency of the generic drug supply chain is a major common interest.

Emer Cooke, the Executive Director of the EMA, was a superb host. The connection between EMA experts and complementary experts at the FDA was in full view, and enthusiasm was high for our bilateral meeting that starts tomorrow at the FDA White Oak Campus in Maryland.

My main takeaways from the trip: 1) The tremendous benefits to our well-being if we can collaborate effectively across the world given that we‘re grappling with common problems in a complex global supply chain environment. 2) The magnitude of the complexity is vast, so it’s critical that we spend energy where it will make the most important differences for public health. 3) The high esteem in which the FDA is regarded across the world. As Churchill said: “the price of greatness is responsibility.” 4) Gratitude for our staff, both those who work in foreign posts and in the U.S. for the dedication and hard work for the good of Americans and people around the world.


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