House Committee Probes NIH Actions After FDA Inspection

The House Energy and Commerce Committee has asked for additional information from NIH to verify corrections and the resolution of clinical research compliance issues, including fungal contamination, uncovered during a 2015 FDA inspection at the Institute’s pharmaceutical development section (see earlier story). The unit eventually shut down its operations until corrective actions are implemented and compliance is restored.

In a 5/25 letter, the committee asked NIH for audit and internal reports related to safety and compliance that were conducted since 4/2016 at the Institute’s Clinical Center. “After about a year since the NIH announced reforms to the NIH Clinical Center, it’s imperative the committee have an understanding of additional action taken to address our concerns, and ensure that NIH’s efforts to ensure safety and compliance of their work are effective,” the committee wrote.