The Media and I: Drug Approval Reciprocity

By Henry I. Miller, MS, MD — Nov 23, 2023
In this radio conversation, Lars Larson and I discuss his concerns about the testing and approval process for new drugs and medical procedures in the United States.
Image by Michi S from Pixabay

We discussed the dangerous shortages of important, commonly prescribed drugs in the U.S. Patients are unable to get prescriptions filled, and hospitals are scrambling to ensure adequate supplies of drugs that are in shortage or to find substitutes for them. At last count, more than 140 were on the FDA's shortage list.

One way to streamline the approval process and reduce excessive regulations of drugs would be a policy change that would enable overseas manufacturers to sell products in the U.S. that already have received marketing approval from certain foreign governments with standards comparable to those of the U.S. FDA, and vice versa. In other words, reciprocity: An approval in one country on the list would be reciprocated automatically by the others. 

Reciprocity would ameliorate other problems as well, such as the FDA dragging its feet on the approval of important drugs and vaccines that have been given the green light elsewhere. 

You can find the audio of our entire conversation with Lars Larson  here, and my article, "Drug Shortages Plague Doctors And Patients. There’s A Straightforward Policy Solution," here.


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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