Regulating Medicines in a Globalized World With Increased Recognition and Reliance Among Regulators: A National Academies Report

Authors

Lawrence O. Gostin, Georgetown University - Law Center - O'Neill Institute for National and Global Health LawFollow
Alastair J. Wood, Vanderbilt University
Patricia A. Cuff, National Academies of Sciences, Engineering, and Medicine

Document Type

Article

Publication Date

3-5-2020

DOI

10.1001/jama.2019.21793

Abstract

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains. Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously. The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, Engineering, and Medicine convened an expert committee to explore the benefits of mutual recognition and other reliance activities among regulators.

Even well-resourced regulators (for example, the FDA, the European Medicines Agency, the Pharmaceutical and Medical Devices Agency Japan, and Health Canada) find it difficult to ensure the safety, efficacy, and quality of medicines in a globalized world. Regulatory failures cause harm to the population and undermine public trust in government. In 2008, following discovery of contaminated heparin originating from China, the Bush administration authorized the FDA to coordinate certain product manufacturing inspections with Australian and European regulators in China and India—setting the stage for “third country” inspections (ie, inspections conducted outside the jurisdiction of either regulator). Yet concerns about the quality of active pharmaceutical ingredients and finished pharmaceutical products persist. For example, in 2018, the FDA recalled generic medications used to treat hypertension and cardiovascular disease because of contamination.

Publication Citation

Journal of the American Medical Association (JAMA), Vol. 324, No. 2, Pp. 145-146.

Scholarly Commons Citation

Gostin, Lawrence O.; Wood, Alastair J.; and Cuff, Patricia A., "Regulating Medicines in a Globalized World With Increased Recognition and Reliance Among Regulators: A National Academies Report" (2020). Georgetown Law Faculty Publications and Other Works. 2302.
https://scholarship.law.georgetown.edu/facpub/2302