Studies on FDA lead to changes in testing standards

The Food and Drug Administration (FDA) is developing guidelines for higher standards for data when testing medical devices on humans, according to the New York Times.

Such standards will include more narrowly defined targets in tests and following patients enrolled in trials more closely. The announcement was made by Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health. The comments were made before the release of two studies that found inadequacies in two trials that the FDA accepted. The trials dealt with high-risk cardiovascular devices, including pacemakers and　implanted defibrillators.

One review was conducted by the FDA and researchers at the Beth Israel Deaconess Medical Center in Boston. The other was published in The Journal of the America Medical Association and was performed by the University of California, San Francisco. They both examined clinical trials used by the FDA from 2000 to 2007. Not only are the quality of these studies important for patient safety, but also because the US Supreme Court recently made a decision that protects the makers of high-risk devices from lawsuits if their product was approved by the FDA.

The two studies found that trials often lack sufficient data and details. Twenty-five percent of the studies did not follow enough patients to have statistically significant data results. While　the study did not find　a correlation between the lack of high-quality data and problems with the devices, Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center, says he believes such links are a possibility.

The FDA critiqued some of the studies’ findings, but the agency is taking action to address the inadequate data and follow-up issues. Dr. Rita Redburg, a professor at the University of California, San Francisco, says she is glad the FDA is being proactive. Action is really the only acceptable response, as the agency must be held to high standards in order to protect patients. With devices such as pacemakers and implanted defibrillators being so high-risk, it is of the utmost importance that the group responsible for approving such devices is held to the highest scientific standards.