FDA and Global Administrative Law

by Sam Halabi — Monday, Nov. 2, 2015

In 2005, Benedict Kingsbury, Nico Krisch, and Richard Steward published their foundational article,The Emergence of Global Administrative Law, in which they argued that a discrete if amorphous body of law existed comprised of transgovernmental regulation and administration “designed to address the consequences of globalized interdependence in such fields as . . . environmental protection . . . telecommunications, trade in products and services, intellectual property, labor standards, and cross-border movements of populations . . .” While national food and drug regulatory authorities played little if any role in their discussion, Kingsbury, Krish, and Steward identified the kind of work FDA undertakes with respect to its global regulatory partnerships: administration based on collective action by transnational networks of national regulatory officials. Yet their assessment of what those networks do and why strongly implied that regulators participating in collaborative networks were driven primarily by their “regulatory mission” toward a discrete set of objectives like internal administrative accountability. FDA’s regulatory partnerships, by contrast, not only take a broader view of what their consumer protection mandate entails, but also the methods by which any given aspect of that mission might be advanced through bilateral or multilateral agreements.

The FDA has, through its Office of Global Regulatory Operations and Policy, long engaged foreign counterparts in exploring areas of mutual interest and forging common regulatory standards that expand access to safe drugs, medical devices, and food for both American and foreign populations. For human drugs, FDA has since 1990 worked with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical Products for Human Use (ICH). Through the ICH process, American, European, and Japanese drug regulatory authorities and pharmaceutical industries meet to discuss and formulate recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, reducing or obviating duplication of testing carried out during the research and development of new human medicines. Those recommendations in turn influence harmonization efforts globally. For inspection of pharmaceutical products, FDA has joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an informal organization of the drug manufacturing inspectorates from 39 countries which share pharmaceutical facility inspection information. For veterinary drugs, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, or VICH, endeavors to harmonize technical requirements for veterinary product registration. For medical devices, FDA cooperates with the International Medical Device Regulators Forum, or IMDRF, a voluntary group of medical device regulators who aim to accelerate international medical device regulatory harmonization and convergence.

Participation in harmonization initiatives, however, is quite different than negotiating and reaching common understandings with foreign counterparts which may be reduced to writing, an act which, whatever the technical legal consequence, exercises real influence on mutual expectations and conduct over critical consumer goods areas. In my next post, I will outline the key agreements FDA pursues and implements to further its consumer protection mandate in the food context specifically, which range from non-specific cooperative commitments as to intelligence sharing to product-specific and risk-specific memoranda of understanding or exchanges of letters meant to address priority consumer safety issues within the context of bilateral or multilateral trade and economic relationships to strongly worded “agreements” that contain treaty-like language and expectations. This analysis will not only shed light on how FDA engages regulatory partners, but also on the growing literature of global administrative law.

Cite As: Author Name, Title, 36 Yale J. on Reg.: Notice & Comment (date), URL.

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About Sam Halabi

Professor Halabi is a scholar of national and global health law with a specialization in health services, pharmaceutical and agrifood business organizations. He serves as a Scholar at the O'Neill Institute for National and Global Health Law at Georgetown University, where he has also served as a special advisor to the Lancet-Georgetown University Commission on Global Health and Law. His work is published in the American Journal of Law and Medicine, the Harvard International Law Journal, the Journal of Law, Medicine, and Ethics, the Lancet, and the Journal of the American Medical Association (JAMA). He has also published volumes on pharmaceutical regulation and global management of infectious disease with Oxford University Press and Elsevier Academic Press. Before earning his J.D. from Harvard Law School, Professor Halabi was awarded a British Marshall scholarship to study in the United Kingdom where he earned an M.Phil in International Relations from the University of Oxford (St. Antony’s College). During the 2003-04 academic year, he served as a Rotary International Ambassadorial Scholar at the American University of Beirut.

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