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By Janet Woodcock, M.D.
We frequently see so many new reports about biomedical breakthroughs that it makes us wonder: "Is this real? Are these new treatments really going to mean anything to me or my family?" Pharmacogenomics, as discussed in this special issue of FDA Consumer magazine, is really happening now.
Why now? Why do we have an opportunity in 2005 that was not possible in the past? Well, the investment in biomedical research, the sequencing of the human genome, and the availability of many technologies today allow us to study each person in greater detail than ever before. We can understand the configuration of each individual's genes. We can do tests on body fluids and proteins to determine the perturbations of disease. And we can understand how individuals react to the course of a disease and to a treatment. These tests were not available in the past. They will allow us to detect differences between patients and diseases much more precisely compared with the relatively crude tools that have been available to doctors until now.
At the FDA, we currently see only a trickle of applications containing pharmacogenomic information, but we expect this trickle to become a flood over the next five years. And this is only good news for patients and their families. For the first time, physicians will have a chance to treat people as individuals, not as members of a "population." We will also be able to treat patients based on the actual biology of the disease--not just according to their symptoms.
People often have similar symptoms, but actually have very different underlying diseases that need different treatments. The pharmacogenomics revolution gives us a chance to sort this out and to treat people with the kind of therapy that's appropriate for them, personally. This gives all of us the chance to fulfill the promise of all the discovery and all the investment in biological science that's been going on during the last 30 years. And it will really help and enhance the health of all Americans. But there are obstacles and these can't be minimized.
For example, this new way of doing things, like most new technologies, can be expensive. And using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain therapeutics, and there may be reluctance on the part of product developers to go down this path. Additionally, there are scientific obstacles that must be overcome. But the biggest concern, really, is that the health care system won't be able to effectively use this information. It could become knowledge that we possess but we don't apply, and this could be tragic for those suffering from diseases or drug side effects. The FDA is working very hard to make sure that this doesn't happen. We want to ensure that these new technologies, which are the future of medical treatment, are developed and made available to doctors and patients as effectively as possible.
How can we make this happen? We're holding workshops and educational sessions with the scientific community, with the academic community, with the industrial sponsors who develop drugs and who develop tests, and with the public to inform them of both the promise and the obstacles. We're also developing guidance that will help developers choose the right pathways to bring these new products to market.
Just as importantly, we're working with the providers of health insurance and health care systems, with the National Institutes of Health, and with other parts of the federal government to make personalized medicine a reality. So, when you read the paper five years from now, we hope you will see news of new breakthroughs that are actually in the hands of health care practitioners. We also hope that you will see new tests and new therapies that are personalized to your specific condition and that can improve your health and not put you at risk of a serious side effect. If that article appears, then we will have been successful in our quest.
Janet Woodcock, M.D., is deputy commissioner for operations and chief operating officer at the U.S. Food and Drug Administration.