However, scientists predict that in the future, genetic intervention in the reproductive tissues (i.e., ovaries and testes) may be possible in which the malfunctioning gene will be replaced with a properly functioning gene in the germ cells (i.e., eggs and sperm). This kind of gene therapy is called germline gene therapy. It would ensure that the normal gene, rather than the abnormal gene, is passed on to the offspring. Such an approach will make gene therapy more efficient, because it frees not only the affected person but also his or her progeny from the burden of the genetic disease. Conversely, with current gene therapy one must treat affected people generation after generation. As of the year 2000, more than 300 protocols for gene therapy were submitted for review by the Center for Biologics Evaluation and Research, a division of the U.S. Food and Drug Administration.4
