Drug & Device News

GAO Finds FDA's Safety Tracking System Lacking

A report issued in December by the Government Accountability Office (GAO), faults the U.S. Food and Drug Administration's (FDA's) management of postmarket drug safety information. The FDA is supposed to keep track of postmarket studies and other data concerning safety problems with FDA-approved medications that have entered the market, but its current systems are apparently inadequate for this purpose. According to the report, “Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER (Center for Druge Evaluation) of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.” Because of these inadequate systems, data is not being recorded and made accessible in a way that would allow the FDA to publish statutorily required reports on potential drug safety issues.

According to the report, the FDA agrees with the GAO's findings and is working to improve its systems to address its concerns.

Test Subject Dies While Taking Experimental Drug

A man taking part in a French drug trial died in January while undergoing treatment with an experimental painkiller drug. He was one of 90 healthy men who had volunteered to be tested with the drug, which was being developed by Bial, a Portuguese pharmaceuticals company. The volunteers were given the medication in differing amounts, and at different times. In all, six test subjects had to be hospitalized, and it was feared that three of them might have suffered brain injuries from the medication. Other test subjects had been treated in clinical trials before this group, with no major adverse reactions.

On Feb. 4, the French General Inspectorate of Social Affairs (IGAS) published a report concerning its investigation of the ill-fated drug trial. Although it did not opine as to the cause of the participant's death, the agency found that the French drug trial company involved made several mistakes after its test subject was hospitalized. One of these was carrying on with the experiment the following day, before finding out if the hospitalized subject was recovering (he was not, and his condition had worsened). The company also failed to inform the remaining test subjects about the hospitalized subject's condition, which violated the terms of their signed informed consent forms stating that they would be informed if anything happened that might affect their willingness to continue with the drug trial.