Thanks to numerous scandals, the FDA is under mounting pressure to step up its oversight of drug development and manufacturing. But what do the metrics look like? Well, the agency has now released numbers showing its efforts to inspect and audit facilities that are involved in drug development specifically, such as clinical trial investigators and institutional review boards.
So here is a summary: in fiscal year 2010, the agency conducted 792 inspections as part of its Bioresearch Monitoring Program, compared with 739 in fiscal year 2003. In each case, look-sees into clinical trial investigators accounted for half of that activity, underscoring the importance placed on ensuring that clinical trial work is handled correctly.
However, in fiscal year 2010, there were 400 inspections of trial investigators, down from 474 in the fiscal year 2009, although this figure was the largest annual tally since 2003. Of the 400 conducted in fiscal year 2010, 77 percent were the result of audits, with the rest due to complaints or referrals. By the way, 116 international investigators were inspected.
Not surprisingly, foreign inspections now occupy more energy. In fiscal year 2010, 70 percent of the investigators inspected were in the US, compared with 91 percent in fiscal year 2003. And 10 percent of the inspections were in Asia and the Pacific region, compared with 4 percent back in 2003. Inspections in Western Europe tripled, to 9 percent of the total.
However, when we eliminate the US from the data, Eastern Europe and Latin America are getting more attention which, of course, reflects the growing number of clinical trials taking place in those regions. Of 116 foreign investigator inspections, 34 percent in fiscal year 2010 were conducted in Asia, compared with 34 percent in 2003. The number of inspections of Eastern European investigators grew to 9 percent, from nothing in 2003. Latin American went to 14 percent from 9 percent.
Overall, there was a big increase in what the FDA calls an Official Action Indicated, rising to 10 percent in fiscal year 2010, from just 1 percent in fiscal year 2003. There were usually multiple deficiencies, but the vast majority involved protocols, recordkeeping, informed consent and accounting for drugs. Twelve percent involved fraudulent data, ahead of 7 percent for adverse events and 2 percent pertained to patient rights or welfare (you can see all the slides here).