Inspector General of the US Department of Health and Human Services has made a devastating report last week on the capability of the US FDA in overseeing clinical trials in that country. The office of the Inspector General found that the FDA inspected just one per cent of clinical trial sites during the period between 2000 and 2005. It should mean that out of an estimated 350,000 trial sites in the whole of the US, FDA was believed to have inspected just 2,855. And whatever inspections of trial sites carried out by FDA were largely targeted on completed trials and often focused on verifying the quality of the data rather than human safety. Strangely enough, there was a lack of follow up inspections on sites which had been issued warnings after being classified as 'official action indicated' for violations of regulatory practices. The FDA is supposed to re-inspect these sites that have been already warned to ensure that there are no repeat violations. But as per the FDA data, which was been found inadequate by the report, the agency only conducted three re-inspections for every 100 inspections that were classified as 'official action indicated'. Another major fault observed is that the FDA did not maintain registries for clinical trials and institutional review boards. Maintaining a registry for clinical trials is considered crucial for identifying all ongoing trials and trial sites in the country.
FDA has been found wanting with regard to safety monitoring of clinical trials for some years now. In 1998, the office of Inspector General had stated that institutional review boards lacked expertise to sufficiently monitor clinical research taking place in its jurisdiction. Again in 2000, FDA was accused of lacking clear and specific guidelines so as to ensure human subject protection. A serious deficiency with the US FDA in protecting subjects from unreasonable risks is the inadequacy of databases and lack of coordination within its ranks. The existing post-marketing surveillance of the FDA is also not adequately protecting patients. The serious adverse drug reactions of already marketed drugs in the US during last 10 years had more than doubled. These are serious charges at an institution which is the regulatory agency of the world's largest and most sophisticated pharmaceutical market. The US government has to wake up to this reality and start a swift fire fighting operation to prevent further erosion of the credibility of US FDA. If the FDA continues to falter, there could be large scale manipulation of clinical trials by the sponsors and contract research organizations leading to marketing of dangerous drugs threatening lives of patients worldwide. Withdrawal of Merck's Vioxx in 2004 and the recent adverse reaction reports of GSK's Avandia have already left a dark shadow over the agency.