Regulatory Focus™ > News Articles > House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit

House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit

Posted 02 October 2015 | By Zachary Brennan 

House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit

The House Energy and Commerce Committee is asking the National Institutes of Health (NIH) for more information on how the temporary closure of its drug manufacturing facility has impacted patients in NIH clinical trials.


The US Food and Drug Administration (FDA) earlier this summer uncovered a series of deficiencies at NIH's Pharmaceutical Development Section (PDS), which acts as a specialty compounding pharmacy managing investigational drugs for clinical trials run by the institutes.

The NIH subsequently suspended operations at PDS after FDA raised 17 deficiency observations, including concerns over possible contamination and air quality.

In June, 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, including the hiring of an outside firm to evaluate the operations.

'Grave Concerns'

But now, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) are seeking more information on precisely how the site's closure is impacting "the welfare of patients in experimental trials who are dependent upon drugs manufactured in the PDS."

The additional information is sought after NIH told the committee last month that several clinical trial protocols "were and continue to be harmed by the disruption caused by the PDS problems," which the congressmen said raises "grave concerns."

Of the 1,332 patients enrolled in 62 affected protocols, NIH said most patients were not affected by the clinical holds because they were not scheduled to receive their study drug during the time of the suspension. And patients who were scheduled to receive their study drug were evaluated on a case-by-case basis by the FDA.

However, some NIH researchers complained of multiple negative effects from delays in obtaining vaccines and other treatments, as well as one patient who had been receiving and benefiting from treatment discontinued because of the PDS issues.

The representatives point to one instance in which a NIH researcher did not seek waivers with FDA to obtain access to a treatment because the "process was too bureaucratic, even though other NIH researchers had done so."

Reps. Upton and Murphy say that NIH's treatment of these patients and "to just leave them hanging, and with no compassion, falls into the definition of 'patient abandonment' and cannot be tolerated."

By next Tuesday, 6 October, the committee seeks information about the status of all the patients in the studies that were suspended as a result of the PDS issues.

Letter to NIH


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