The Media and I: Drug Reciprocity

By Henry I. Miller, MS, MD — Sep 19, 2024
Lars Larson began our most recent conversation by noting the increase in life expectancy in the U.S., largely due to advances in drug development. However, he quickly pivoted to criticize current drug shortages, which was the subject of a recent article of mine.
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I confirmed that drug shortages are indeed a serious issue. A University of Utah study found that there are shortages of more than 300 essential drugs, including pain relievers, cancer medications, anesthetics, and even basic IV solutions. Lars raised concerns about relying on foreign production for crucial goods, suggesting incentivizing companies to produce these drugs domestically. 

I offered a more practical solution -- allowing reciprocity of drug approvals between the FDA and foreign drug regulators, enabling drugs already approved in countries like the UK or Australia, or the European Medicines Agency, to be marketed in the US automatically, without lengthy negotiations and reviews. However, US drug companies are reluctant to endorse this change in policy because of fear of foreign competition.  The FDA also dislikes the proposed policy, because of fear of redundancy.  

Reciprocity in drug approvals is the most practical and efficient solution to the drug shortage crisis.

You can hear the whole conversation here.

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Henry I. Miller, MS, MD

Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.

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