NIH Plots out Path Forward After Disastrous FDA Inspection

Posted 22 June 2015 By Alexander Gaffney, RAC

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The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities.

Background

On 4 June 2015, NIH issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) following an inspection by FDA that found "a series of deficiencies."

PDS is NIH's pharmaceutical development arm, and manages investigational drugs for government-run clinical trials. The section is run by about 20 staff, and acts as a compounding pharmacy with specialized capabilities.

"[PDS staff] oversee the production of tablets and capsules and sterile parenteral dosage forms, as well as the formulation and production of dosage forms not available from commercial sponsors," NIH explains on its website. "The analytical unit conducts quality control studies to ensure the integrity and purity of the products produced."

During an inspection, FDA staff uncovered numerous and troubling deficiencies, including many conditions which could cause drugs to become contaminated. At its core, FDA said, the facilities had not been designed properly, which increased the chances of contaminants entering the facility from aseptic areas, improperly designed exhaust vents and more.

In all, FDA's report noted 17 alleged deficiencies.

NIH Remediation Plan

On 19 June 2015, NIH released two interim corrective action plans (CAPs) establishing the steps it plans to take to address the problems found at its PDS Clinical Center.

"As part of the plan, NIH will hire a contracting firm experienced in Current Good Manufacturing Practice (CGMP) regulations and procedures," it said in a statement. "The firm will provide a full evaluation of the PDS operations and make recommendations for improvement and for addressing all FDA concerns."

NIH will also establish an "external group of advisors" to oversee the implementation of the corrective action plan, it added.

NIH said it expects all corrections to be in place by September 2015.

 

NIH Statement

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Tags: NIH, National Institutes of Health, Pharmaceutical Development Section, PDS, Corrective Action Plan

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