Weaknesses in the US Food and Drug Administration’s (FDA’s) ability to monitor clinical trials have been identified by the US Department of Health and Human Services (HHS).
These include a failure to provide sufficient oversight to ensure the protection of patients participating in clinical trials. In particular the HHS reported that data limitations prevent the FDA from effectively managing clinical trials conducted through its Bioresearch Monitoring Program.
Inspection of clinical trial sites is another area the Government Accountability Office (GAO) has been monitoring after the HHS reported that only one per cent had been checked between 2000 and 2005.
The GAO’s own investigation into the FDA’s activities has highlighted a failure to analyse how gender and age affects the safety and effectiveness of particular drugs.
A recommendation was made by the GAO in 2001 that the FDA “consistently and systematically discuss gender differences in their written reviews of new drug applications” but the agency has failed to implement this.
In addition the GAO is concerned the FDA is not analysing the impact age has on the safety and efficacy of drugs even when the product is treating conditions that are commoner in the elderly.
The GAO’s investigation into the FDA’s ability to oversee clinical trials started in January 2007, when the area was identified as being “high-risk”. These are classified as areas vulnerable to fraud, waste and mismanagement or those in need of significant changes to address major challenges.