The US National Institutes of Health to address deficiencies in unit that makes drugs for research studies

The US National Institutes of Health (NIH) has submitted an interim plan to address recent problems identified by Food and Drug Administration (FDA) inspectors that led the NIH to suspend manufacturing at its pharmaceutical development section. In May, the FDA determined that there were serious manufacturing problems at the NIH Clinical Center’s Pharmaceutical Development Section (PDS), which makes drugs for research studies conducted in hospitals and collaborating facilities.

Beyond halting drug production on 22 May, the NIH has also quarantined all sterile products that were produced prior to that date, and it has implemented re-testing of all quarantined lots.

The NIH’s plan to address the deficiencies will mean hiring a contracting firm experienced in current good manufacturing practice regulations (cGMP) to evaluate PDS operations. In addition, the NIH will establish an external group of advisers with expertise in cGMP facility management, clinical research, engineering and regulatory requirements to consider the contractor’s recommendations and oversee any changes.

The NIH has set out key milestones in its plan, including training and re-training personnel in GMP by 14 August.

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