The FDA’s International Regulatory Cooperative Activities

by Sam Halabi — Tuesday, June 16, 2015

In my last two posts, I emphasized the relationship between regulatory capacity building, harmonization, and cooperation using examples from the CDC’s and USAID’s experiences in Liberia and Laos. Yet so far as global supply chains go, the FDA is now and since its establishment has been the most important agency with respect to both cooperation with foreign national regulatory authorities and the promotion of harmonization activities with international organizations and consortia.

Given FDA’s preeminence in the field, it is surprising how little research has been conducted into how FDA envisions its role as a global regulatory partner, the instruments it uses to shape that role, and how its self-perception of that role has changed over time. To some extent, FDA’s global role is constrained by the idiosyncrasies of Congressional and Executive management. For example, despite the fact that FDA is the most important food regulatory agency, the US office engaging with the most important international food safety organization, the Codex Alimentarius Commission , is housed within the Food Safety and Inspection Service of the USDA. Congress passed the most sweeping legislation affecting food safety in 70 years with the Food Safety Modernization Act, substantially growing FDA’s international reach, but retaining the Codex office at USDA.

But even within the food and drug safety portfolios clearly within FDA’s authority, there is no systematic analysis of FDA’s essentially diplomatic activities. For example, FDA is party to over 120 international agreements including confidentiality arrangements, statements of intent, exchanges of letters, memoranda of understanding, systems of recognition agreements, agreements formed within broader bilateral cooperation agreements forged by the White House, and free standing quasi-treaties that, at least on their face, appear to bypass or at least modify the diplomatic processes typically associated with engagement with foreign sovereigns. What, if any, coherent picture of FDA’s global role can be assembled from these international agreements? In my next several posts, I’ll attempt to shed light on that question.

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

This entry was tagged .

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.

Leave a Reply

Your email address will not be published. Required fields are marked *