The Evolution of the Regulatory Response to Products of Recombinant DNA Technology

Abstract

Safety and efficacy have always been the primary concerns of the FDA when dealing with new products. These concerns are magnified when a new, untested technology is producing the new products. To date, the products produced by recombinant DNA technology for use as pharmaceuticals in humans have been proteins. Although the biomedical community now has extensive experience in isolating and characterizing proteins, the proof that a protein is pure does not imply that the same protein will be safe or effective when injected into a person. However, before a protein can be proven safe and effective, proof is needed to show that the product has the desired structure and function and herein lies the first stage of the analytical challenge of safe pharmaceuticals.