Overseas sites were inspected much less frequently than those in the U.S., the investigation disclosed. "Our regression analysis indicated that FDA was 16 times more likely to inspect a clinical investigator at a domestic site than a foreign site," according to the report.
FDA staff told the investigators that logistical challenges hamper their ability to inspect foreign trial sites.
"According to these officials, inspectors are generally allowed one week, including travel time, to conduct these inspections. FDA is unable to easily extend the inspections if significant compliance issues or other problems arise," the report said.
Other obstacles cited by the FDA included the need for work visas and translators, as well as the expense.
Officials told the HHS investigators that each inspection costs about $40,000 and the trend toward multi-site trials with small numbers of participants per site made it more difficult for the agency to justify the costs of inspections.
FDA's Sharfstein indicated that the agency shared the concerns expressed in the report and was taking steps to address them.
"For each [Office of the Inspector General] recommendation, the Agency either has ongoing efforts to address the recommendation or has initiated development of new procedures that will incorporate the recommendation," he wrote.