Last week President Bush signed the Genetic Information Non-Discrimination Act (or GINA) which the LAF endorsed and supported. The law is intended to protect individuals from employers or insurance companies misusing his or her genetic information. The passing of this law is a huge landmark in moving forward with targeted therapeutics and personalized medicine. But, most people probably didn’t go out and read the bill right away. So for those who want a summary, the Genetics and Public Policy Center has provided one that outlines what rights you have and what the bill does and does not protect.
In our next steps, it is important to remember that while genetic technologies have matured a great deal over the last decade, their use in the clinic to improve health is now entering the testing phase. The field called pharmacogenomics is emerging, but please be aware that the FDA has approved very few genetic tests for the purposes of determining therapies. So now comes stage two for personalized medicine. However, there are several tests in clinical trial now, but it is still going to take a few years to get tests validated and ensure they help to improve health. With the passing of this law there is likely to be increased marketing of various genetic tests with misleading claims as to how they can help. And many claims will not be FDA approved. So as we move forward we will need to make sure agencies like the FDA and the Federal Trade Commission are ready, willing, and able to make sure that those tests that do make it out to market are validated. We also must ensure that patients and clinicians alike are using them appropriately.