FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs

NIH Task Force Finds Problems With Compounders Are ‘Widespread and Longstanding’

Dec. 21, 2015
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Following congressional outcry, an NIH task force issued findings that show underlying problems with its now-shuttered drug compounding facilities were “widespread and longstanding,” but did not cause any direct harm to patients.

At the center of the controversy was the NIH Clinical Center’s Pharmaceutical Development Service (PDS), which was shut down indefinitely on June 4 after a May 10 to 29, FDA inspection found serious issues.

Despite reassurances by the NIH, the House demanded information on all patients in NIH clinical trials. The task force monitored the status and safety of research participants receiving PDS products, identified alternative product sources to minimize research interruptions, worked with the FDA to develop corrective actions and scrutinized the root cause of the failures at the facility and its sterile drug production.

The task force’s report says that the problems would require significant facility construction for both the PDS and the NIH’s Intravenous Admixture Unit to meet cGMP compliance. The report notes that even at its construction, the PDS was not designed to meet cGMP requirements for all of the types of products that were planned.

In response to the task force’s findings, NIH Director Francis Collins says he will establish a new Office of Research Support and Compliance within the NIH Office of Intramural Research to maintain compliance with research regulations and standards.

Collins also will examine structural and cultural issues and make recommendations to improve the organization, financing, and management of the NIH Clinical Center in spring 2016.

To view the task force’s report, go to www.fdanews.com/12-15-15-NIHReport.pdf.