The emergence of recombinant DNA technology in the 1970s has given rise to new diagnostic techniques based on DNA probes. The Food and Drug Administration's interest in these probes stems from its regulatory responsibilities regarding DNA probes as medical devices. The agency also sees DNA probes as valuable tools in meeting its mission of identifying, preventing, and resolving public health problems, especially in the area of food safety. The development of DNA probes for genetic diseases is raising medical and ethical questions that must be addressed by the medical community, whose ultimate responsibility must be to see that this new technology is used wisely, appropriately, and correctly.
KIE: The author writes about DNA probes, a spin-off technology from recombinant DNA research, from two perspectives: that of a physician, and that of the federal Commissioner of Food and Drugs. Young discusses the Food and Drug Administration's role in regulating DNA probes, as well as the agency's interest in using the probes to confront public health problems such as food pathogens. He also comments on some aspects of molecular biology's growing role in medicine. Young emphasizes that the FDA's responsibility for regulating DNA probes is limited, and that the medical community is obligated to ensure that the probes are used appropriately as diagnostic aids, particularly when screening for genetic disease.