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U.S. and EU Act Together on Global Medical Safety

This is the fourth post in our weeklong blog series, Talking Trade: Stories of the Transatlantic Exchange.

By Donald Prater, Director, FDA Europe at the U.S. Mission to the EU

U.S. demand for medical products grew substantially between the late 1990s and 2010, spurred in large part by the emergence of new medical technologies and services.  Increasingly, this demand has been met by imported products. Since 2002, for example, imports of pharmaceutical products and biologics have more than doubled, and medical device imports have quadrupled. Foreign-sourced pharmaceuticals now account for some 40% of medicines and an astonishing 80% of active ingredients in U.S.-consumed drugs.

pharmaceutical image 1Similarly, medical products in Europe are increasingly reliant on foreign-sourced materials and face the same challenges of longer and more complex supply chains. Additional shared challenges include an increasing number of clinical trials conducted across the world and risks from substandard/counterfeit/falsified products finding their way to consumers.

As the Director of FDA’s Europe Office, it is my mission to coordinate our global engagement within a European regulatory and public health context to ensure the safety and quality of FDA-regulated products. Many of the regulatory counterparts with which FDA works are located in Europe. In fact, over 50% of FDA’s international agreements are with entities located or headquartered in Europe.

With our European regulatory counterparts, FDA is actively sharing data, information, and technical expertise. Since 2009, FDA and the European Medicines Agency have enhanced our collaboration through the exchange of dedicated liaison officers embedded within each agency, and through engagement in 11 “clusters of activity”, including advanced medical therapies, biosimilar medicines, blood products, oncology, orphan products, patient involvement, pediatrics, pharmacogenomics, pharmacovigilance, vaccines, and veterinary medicines.

pharmaceutical image 2Ensuring the quality of products in a global environment is a tall order. At every stage in the production of pharmaceutical products, and all along the global supply chain, things can go wrong.  Products can be improperly formulated, manufactured, or packaged. They can be contaminated or counterfeited. And the challenges are multiplied when the supply chain stretches around the world.

Today, the FDA regulates products from over 150 countries, many with much less sophisticated regulatory systems than our own. International standards harmonization and collaboration, for example, in regulated-site inspection activities, can help leverage the limited resources of FDA and our foreign counterparts. It is for this reason that our regulatory partners in Europe are such an important ally.

In 2014, the U.S. and EU launched the U.S.-EU Mutual Reliance Initiative, a strategic collaboration between the FDA, the European Commission and the European Medicines Agency. The aim of the initiative is to determine that each side has the capability of conducting inspections that meet the respective regulatory requirements. Once a determination is made, each side would then be able to rely on the other’s inspections to be more efficient and effective in targeting resources for inspecting pharmaceutical operations and for other appropriate purposes.

This type of collaboration not only increases our ability to evaluate pharmaceutical facilities, but allows experts to learn from each other. It also benefits patients by refocusing efforts to better address problems before adverse public health outcomes potentially occur. The result: more efficient use of resources and improved pharmaceutical availability.

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