BREAKTRHOUGH BIOTECHNOLOGIES: CAN THE FDA KEEP UP WITH THE SPEED OF SCIENCE?

Abstract

Biotechnology advances have the potential to dramatically change the practice of medicine. Currently research is underway to find cures for diseases that were before untreatable, and many biotechnology products are already on the market improving the drugs and devices we use today. However, one important factor to ensure that the pace of biotechnology goes on unhindered is proper regulation. As the guardian of public health, the Food and Drug Administration has struggled to meet the demands of the rapidly growing field. In particular, the FDA has recognized three potential breakthrough areas of biotechnology that may need regulatory reform: cell and gene therapy, pharmacogenetics / pharmacogenomics, and novel drug delivery. This paper will examine the current state of these three technologies and the regulatory landscape surrounding them.