The US Food and Drug Administration and pharmaceutical companies are failing to meet their obligations in filing and monitoring information from post-marketing or Phase IV studies, according to an internal Department of Health and Human Services report.
The Office of the Inspector General of the DHHS – the department that also governs the FDA – concludes that the agency is unable to monitor the progress or completion of post-marketing studies effectively, does not consider the issue a top priority and has limited powers if drug applicants fail to comply.
The finding is worrying as nearly half (48%) of new drug applications cleared between 1990 and 2004 included at least one post-marketing study as a condition of approval, according to the OIG.
The OIG’s finding come just a few weeks after another federal body – the Government Accountability Office – questioned the FDA’s ability to monitoring the safety of drugs once they are n the market because its current structure causes a conflict of interest, in which officials who have previously deemed a drug safe may be reluctant to reverse their decisions later.
Among the findings of the OIG report were that 35% of the annual status reports (ASRs) that drugmakers were due to file in fiscal 2004 were either missing entirely or contained no information on outstanding post-marketing study commitments.
The FDA disagreed with the finding that it cannot monitor post-marketing studies effectively, but acknowledged that its procedures needed to be improved and said efforts to achieve this were already in place.
Crucially, the agency insists that to meet the requirements could require a change in the legislature, and the OIG said its report has been modified to reflect that possibility.
The FDA recently launched its own internal investigation into its handling of post-marketing studies. This probe, conducted by independent audit firm Booz Allen Hamilton, got underway in April and is expected to take around a year to complete.