FDA Faulted for Spotty Oversight of Data Coming from Overseas

"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.

Costly Inspections

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.

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