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NIH Suspends Drug Production Unit After FDA Inspection Finds Major Problems

Posted 05 June 2015 | By Alexander Gaffney, RAC

NIH Suspends Drug Production Unit After FDA Inspection Finds Major Problems

Pharmaceutical companies frequently find themselves sanctioned by the US Food and Drug Administration (FDA) for failing to adhere to federal good manufacturing practice (GMP) requirements. But it's an exceptionally rare occurrence to see FDA cracking down on a fellow federal government agency, as it is this week.

On 4 June 2015, the National Institutes of Health (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."

FDA Inspection

But despite its public claims of excellence, NIH's pharmaceutical operations appear to have suffered from some of the same problems that have plagued private-sector pharmaceutical compounders for years.

NIH's statement indicates that a complaint triggered an inspection of PDS' facilities by FDA in late May 2015. Specifically, two vials of albumin "were found to have fungal contamination." At least six patients may have been exposed to albumin made from the same batch, NIH said.

For federal regulators, the contamination is at least troubling, and potentially far worse. In 2012, deficient practices at a Massachusetts-based compounding pharmacy resulted in dozens of deaths and the eventual overhaul of federal regulations overseeing compounding pharmacies.

Inspection Findings

The report generated by FDA's inspection of NIH's PDS indicates a long series of problems at the facility, many of which are similar to deficiencies found at private-sector facilities.

For example, FDA observed an employee processing sterile drugs without proper covering from protective equipment. PDS also failed to conduct air flow studies, which are used to ensure that products are protected from potential airborne contaminants.

Other problems were more serious. FDA determined that the drug production operations at the facility were inherently deficient because the facility had not been designed to separate the aseptic processing area from the common pharmacy. That increases the risk of contaminants being introduced in the aseptic area.

FDA's inspection report also notes extensive concerns about air quality. Certain exhaust vents did not contain required filters or screens, and air systems meant to limit the spread of contaminants did not function properly at all times.

Inspectors also said PDS failed to collect sufficient information about the "microbial quality" of the manufacturing environment. NIH staff did not routinely monitor the air or production hoods for microbial contaminants, and FDA said it found insects in two of the cleanroom's light bays.

In all, FDA's report—essentially an FDA Form 483—had 17 deficiency observations.

NIH said it would immediately suspend operations at PDS "until all problems are fully understood and corrected." Existing products were being tested for contaminants. NIH is also working to secure alternative arrangements for the approximately 250 patients enrolled in trials sourced with drugs from PDS.

A corrective action plan is expected to be submitted to FDA by 19 June 2015, PDS said.


NIH Statement

FDA Inspection Report

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