October 29th marks the 40th anniversary of one of biotechnology’s most significant milestones — the approval by the FDA of human insulin synthesized in genetically engineered bacteria to treat diabetes. The first “biopharmaceutical,” or drug made with molecular genetic engineering techniques, to be approved, it launched a revolutionary era in drug development.
Insulin is secreted in the pancreas and is essential to the metabolism of carbohydrates and fats. Insulin deficiency leads to the development of diabetes. Many diabetics require regular injections of insulin to maintain life and health.
As the FDA medical reviewer and the head of the evaluation team for “Humulin,” I had a front-row seat. The saga is remarkable in several ways, not least of which is that although both the drugmakers and regulators were exploring unknown territory, the development of the drug and its regulatory review progressed smoothly and rapidly.