THE BUREAUCRATIC MINDSET

2 PARAGRAPHS 4 LIBERTY: 471

Look at the history of our federal Food and Drug Administration (otherwise known as the FDA): over the years it has evolved into protecting itself and its decision-makers from the criticism of bringing a new pharmaceutical drug to the market too fast. And, in this regard, a revealing article written by Henry I. Miller in the Winter 2023-2024 edition of the CATO Institute’s publication Regulation discusses the story of the FDA’s approval of synthetic insulin to counteract diabetes in humans in 1982. Since about 1922, insulin to counteract diabetes had been processed from the pancreases of pigs and cows. But it took more than two tons of pig and cow parts to produce just 8 ounces of insulin, and this new product still differed slightly from human insulin. Then, beginning in 1973, a new process using a new technique called “gene splicing” from human DNA was found to produce an almost unlimited supply of insulin that was almost identical to that produced by the human body. So this new insulin was brought to an FDA team headed by the author, Mr. Miller, to review the data and make recommendations as to whether it should be certified for sale to the public.

According to the author, since they were dealing with human tissue it took only five months to conclude that this new drug was safe for public use, when the average time back then for approval was 30.5 months. However, when he took his team’s recommendations to his supervisor, the response was “Four months? No way! If anything goes wrong with this product down the road, people will say we rushed it, and we will be toast.” So that was the “bureaucratic mindset.” But when that supervisor soon went on vacation for a month, the author took it to his boss, who was the division director, and he signed off. So the author goes on to cite the wisdom of one of my heroes, Dr. Milton Friedman, who said that to understand the motivation of an individual or organization you had to “follow the self-interest.” Why? Because it is in people’s self-interest to stay out of trouble, and a good way to do that is not to be seen as quickly approving a new drug or anything else that might later experience unanticipated problems. And that is still with us today, since it now takes an average of 10 to 12 years for the FDA to approve a new drug, and at an average cost of more than $2.5 billion. Imagine how many lives are lost and unnecessary suffering occurs because of that (bureaucratically logical) result! So that has been the bureaucratic mindset at the FDA, and probably most other administrative agencies, and undoubtedly with many other public and private organizations as well – and with many individual people too! We probably cannot change that reality, but all of us should be mindful of it and try to adjust accordingly!

(From a Family Circus cartoon about running a Marathon: “I suppose ‘the Thrill of Victory’ would be a whole lot more enjoyable if it wasn’t for ‘the Agony of Da Feet!’” )