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By: Robert M. Califf, M.D., Commissioner of Food and Drugs
Recently I had the privilege of official travel to the U.K. and European Union (EU) with our extraordinary global affairs team. We visited with The Medicines and Healthcare products Regulatory Agency (MHRA) and representatives of the U.K. medical device, digital and pharmaceutical industries in London and then moved on to Oxford for an exchange and update on the conduct of clinical trials and mutual concerns about cybersecurity. We then traveled to Brussels, where we visited the U.S. Mission to the EU and met with the European Commission (EC), European Food Safety Authority (EFSA), and representatives of European medical products and food industries. Finally, we spent time in Amsterdam meeting with the European Medicines Agency (EMA).
While there were important exchanges relating to all of these commodities regulated by the U.S. Food and Drug Administration, the common theme of both our previous trip to Singapore and India and this excursion was the value of international collaboration and exchange of perspectives. We all want safe and nutritious food, safe and effective medical products, and freedom from the death and disability caused by tobacco products, and we are all increasingly dependent on our complex, interdigitated supply chains. We deal with the same fundamental issues as the regulators and public health officials we met with, and increasingly, the changes in our computing and data infrastructure are enabling us to share and exchange information much more quickly across the global expanse.
The dominant message in Europe about medical devices was a major concern from the industry about fragmentation of regulation in Europe relative to the more centralized U.S. system for device regulation. It’s been interesting during my career on all sides of device development, use in practice, and regulation, to experience a significant reversal of views of the industry about the U.S.-U.K.-EU comparisons. Early in my career, Europe was the primary focus for early device development, largely related to opinions about regulatory stringency that many believed led to a faster, less demanding path to market. Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health (CDRH) and the CDRH team have done a remarkable job of maintaining regulatory quality while using interactions with industry and the clinical practice world to create an innovative and vibrant ecosystem in the U.S. There is awareness in the U.K. and EU that more effective, predictable regulation can enable the industry to thrive while continuously improving the follow-up and surveillance of devices. Here, the remarkable success of the recent annual meeting of the International Medical Device Regulators Forum in Washington raised hopes that global, streamlined adoption of common regulatory approaches is a viable long-term goal.
Regardless of one’s view of BREXIT, one result has been that the MHRA has gone from being one part of the larger EU regulatory system working with EMA, to an agency that must operate on its own to regulate all drugs, devices and vapes in the U.K. Adjusting to the increase in workload has put major stress on the MHRA and the EMA initially lost a significant amount of regulatory capacity when the alliance changed. The MHRA will be losing a remarkably capable leader when Dame June Raine, DBE, retires this year. She is a strong leader who has held it together in a difficult time of transition. I’m sure the U.K. will find a new leader from its reservoir of medical product expertise to match the competent leadership of Emer Cooke at EMA.
Meanwhile, the EMA has regrouped from its London headquarters to a beautiful building in Amsterdam (the largest green wall in that part of Europe). Our drugs and biologics discussions with the EC and EMA covered a range of topics—access, shortages, generics, post-market evidence and rare disease needs among others. The opportunity for synergy across these domains is substantial and I look forward to the upcoming FDA-EU bilateral meeting at the FDA White Oak Campus in Maryland. And by the way, EFSA will be included at that meeting for the first time.
The regulation of food was not a part of the U.K. trip, but it was evident in our EU discussions that food safety and nutrition are “front burner” issues. The cultural values of Europe are heterogeneous—it’s a challenge to reach agreement among 27 countries—and in aggregate there are significant differences with the approach in the U.S. But we have much more in common than our differences. Huge effects on our societies will follow from how we deal with the promise and risks of new biotechnologies related to agriculture and sharpening our understanding of the impact of ultraprocessing on food cost and access, while getting on top of the evolving concerns about its impact on nutrition and disease. And we have historic differences in the manner in which we assess the risk of chemical substances in the food—understanding the best way forward will be important as we face growing concerns about the environment and its impact on individual and population health.
A final reflection: I’ve thoroughly enjoyed the chance to spend personal time with our Office of Global Policy and Strategy (OGPS) colleagues as we have traveled and interacted with others. This is a dedicated and talented group of people working every day to advance the FDA’s mission in complex, and often difficult circumstances. Taking a foreign post includes the amazing experience of living in a different place with a different culture, but it also brings stress and complexity with family and personal adjustment. Additionally, our OGPS colleagues have to deal with significant differences in regulations that guide our different product centers, and the foreign post employees must represent all these perspectives as they represent us in the field. As if that’s not enough, the multidimensional priorities of the FDA, the rest of the foreign mission and the needs and pressures of the host countries and regions require an adaptive mindset. I have asked Mark Abdoo and Kim Trzeciak to put together a strategic document on global affairs that looks forward to the next decade to shape our plans and requests for funding.
In conclusion, I ended the trips with appreciation for the importance of our global mission, reaffirmation of the high regard in which the FDA is held around the world, and admiration for the people who carry the FDA torch around the world. I’ll follow up with specific blogs with observations about the U.K. and EU in the near future.
