Which statement about insulin reflects its regulatory milestone?

• A. It is the first recombinant DNA drug product (protein) approved by the FDA.
• B. It is the first small-molecule drug approved for diabetes.
• C. It is a lipid hormone involved in metabolism.
• D. It is a carbohydrate used in glucose transport.

Answer: (A)

Insulin marks a regulatory milestone because it was the first therapeutic protein produced by recombinant DNA technology to be approved by the FDA. This showed that a human protein could be made in microorganisms, purified, and used safely in patients, delivering a consistent, scalable supply and reducing immunogenic concerns associated with animal-derived insulin. It’s not a small-molecule diabetes drug, a lipid hormone, or a carbohydrate—insulin is a peptide hormone. The approval of recombinant human insulin thus demonstrated that biotech protein drugs could meet rigorous safety and efficacy standards, opening the door to the vast field of biologics that followed.