The FDA Is Stifling Pharmaceutical Innovation

Commentary From Robert Zubrin on National Review.com (Sept. 2):

I started looking into the Food and Drug Administration (FDA) when I found it is preventing America from effectively responding to the COVID-19 epidemic. By blocking businesses and schools from using cheap, fast tests that could enable them to identify and send home COVID carriers, the FDA is stopping us from employing a technology that would allow us stay open while crushing the pandemic.

Is this an isolated case of malfeasance by the FDA? Or is it part of a consistent pattern?

In further researching the matter, I encountered numerous reports of similar past instances, but nowhere were they better analyzed and summarized than in the 2018 book Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It. Written by former Upjohn research scientist Dr. Mary Ruwart, the book is a comprehensive — and frankly shocking — indictment of a federal bureaucracy gone mad.

The FDA was established in 1906 by the Pure Food and Drug Act, but it was relatively harmless until its powers were radically expanded in 1962 by the passage of the Kefauver–Harris amendments that gave it absolute power over the pharmaceutical industry. As documented extensively by Ruwart, since that time, the FDA has indulged in ever greater abuse of these powers, inflicting alarming harm on America — and humanity at large — in the process.

By radically and continually expanding the paperwork, testing, and other legal and regulatory obstacles to bring a new drug to market or treatment to practice, since 1962 the FDA has caused the development time for new drugs to triple (from an average of four years before the amendments to twelve today), the cost to multiply 40-fold, and the number of new drugs introduced per year to be cut fivefold. Within five years of the amendments’ passage, 98 percent of U.S. drug companies (including all the small innovative ones) were eliminated from the drug-development business. Before the amendments, 50 percent of all new drugs invented worldwide were developed in the U.S. Today, it is 15 percent. Not only that, many new life-saving drugs have been kept out of the United States for as many as 20 years after they were put into use in the U.K. or Europe. [read more]