The approval of human insulin synthesized in genetically engineered bacteria on October 29, 1982, marked a significant milestone in biotechnology. This “biopharmaceutical” was the first drug made using molecular genetic engineering techniques to be approved by the FDA. The development of human insulin was a response to the potential shortage of animal-derived insulin, which was the only treatment available for diabetes at the time. Eli Lilly and Company, in collaboration with Genentech, Inc., developed a process to produce human insulin in bacteria using recombinant DNA technology. The FDA approved the drug in just five months, a remarkably rapid review process. The approval of human insulin had a significant impact on the biotechnology industry, demonstrating the potential of genetic engineering to produce life-saving medicines. However, the author notes that the FDA’s review process has not kept pace with advances in technology, and regulatory barriers have hindered the development of other biotech products, such as genetically engineered animals and mosquitoes. The author calls for congressional oversight to create a more constructive balance between regulation and innovation.
A Cautionary Tale: Commemorating the FDA’s Pioneering Approval of Genetically Engineered Human Insulin
