By: Howard Sklamberg, J.D., Lou Valdez, and Donald Prater
On a recent trip to Brussels, our FDA delegation met with many of our European Union (EU) regulatory counterparts and stakeholders to discuss ways to strengthen our shared commitment to product safety and public health.
Reflecting the broad scope of our transatlantic dialogue, we engaged on an array of issues, including supply chain safety, quality metrics, risk-based surveillance, data integrity, mutual reliance, and food safety systems.
Building on previous exchanges between FDA and the European Parliament (EP), we first met with Members of the Environment, Public Health and Food Safety Committee, known as ENVI. ENVI Committee members visited FDA in 2013 and 2015 to share their perspective on how certain health-related topics are being addressed in the European Union. In addition, our FDA delegation exchanged views on recent trilateral cooperation with India and China on Good Clinical Practices and food safety and other approaches to cooperation on the international stage.
We then met with the head of the European Commission’s Directorate General for Health and Food Safety (DG SANTE), Director General Xavier Prats-Monné, and his colleagues.
We shared our observations on several topics, including:
- How drug development has changed, including globalization of suppliers and distributors;
- The challenges among regulatory bodies in keeping pace with risk-based allocation of inspection resources;
- The complexity of the global supply chain and the need to collaborate on enforcement;
- The significant progress being made on the Mutual Reliance Initiative (MRI);
- Pharmaceutical GMP inspections; and
- The interaction among FDA’s Europe, China, and India offices and regulatory counterparts in the EU and Governments of China and India.
We then turned to food safety. Currently, the U.S. and the European Commission are working on a Food Safety Systems Recognition arrangement, a program that FDA has developed to increase regulatory cooperation and build toward reliance on the work of regulatory counterparts.
Such cooperation is facilitated through the reciprocal assessment of one another’s food safety systems to ensure the safety of foods produced under one another’s oversight. The United States already has an arrangement in place with New Zealand and recently signed one with Canada.
We also reviewed the Food Safety Modernization Act (FSMA) and discussed ways FDA and the European Commission can assist suppliers in the EU to better understand the FSMA requirements. Acknowledging that food safety standards are quite high in the United States and the EU, we discussed ways we can leverage the systems on both sides of the Atlantic to further protect consumers and more efficiently use our oversight resources globally.
Next up were meetings on medical devices and cosmetics with the Directorate General for Internal Market, Industry, Entrepreneurship, and SMEs, also known as DG GROWTH.
We were welcomed by Carlo Pettinelli, Head of the Directorate for Consumer, Environmental and Health Technologies, and we discussed the key objectives of the Medical Device Single Audit Program (MDSAP) of the International Medical Device Regulators Forum (IMDRF). Mr. Pettinelli acknowledged the importance of MDSAP, and indicated that the European Commission would continue to provide coordination and communication to support the engagement of EU Member States in the program.
We also set aside time for discussion with key industry stakeholders representing medical products – primarily drugs and devices, including, the American Chamber of Commerce Healthcare Committee to the EU and the European Federation of Pharmaceutical Industry Association (EFPIA). There we reviewed FDA’s Pharmaceutical Quality and MRI initiatives.
Our trip concluded with a media roundtable and a briefing to the Deputy Chief of Mission and staff at the U.S. Mission to the European Union. Our FDA Europe Office is based at the USEU and provides critical support to U.S. Ambassador Anthony Gardner.
Throughout all our meetings, one theme was crystal clear: Transatlantic cooperation is vitally important to address the challenges and opportunities of a globalized marketplace. By carefully evaluating and understanding each other’s regulatory systems, there is tremendous potential to better allocate our resources based on risk, and improve the safety of food, medical products, cosmetics, and other products around the world.
Howard Sklamberg, J.D., is the Deputy Commissioner for Global Regulatory Operations and Policy
Mary Lou Valdez is the Associate Commissioner for International Programs
Donald Prater is Director of FDA’s Europe Office