NIH Facility Shut Down Due to Drug Safety Concerns
The NIH today suspended all operations of its Clinical Center Pharmaceutical Development Section after discovering severe manufacturing deficiencies.
The National Institutes of Health (NIH) today suspended all operations of its Clinical Center Pharmaceutical Development Section (PDS), a factory that makes products for clinical studies conducted in hospitals and collaborating facilities, after discovering severe manufacturing issues and deficiencies.
In April, 2 vials of albumin produced at the facility were found to have fungal contamination. Vials manufactured from the same batch were administered to 6 patients, who have since been notified of potential contamination, though none have yet developed signs of infection or illness.
A subsequent FDA inspection of the PDS revealed a number of physical deficiencies, including flaws in the air handling system, as well as operational failures such as inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures. Other deficiencies were identified in the Clinical Center Pharmacy, but they were not as significant.
“This is a distressing and unacceptable situation,” said NIH Director Francis S. Collins, MD, PhD, in a press release. “The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s PDS is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”
In addition to ceasing the production and distribution of its products, the NIH will notify the approximately 250 patients across 46 different studies that are potentially affected.
“Our first responsibility is the safety and care of our patients,” Dr. Collins stated. “NIH leadership is determined to identify and correct all of the deficiencies that have led to this situation.”
An external group of experts in microbiology and sterile manufacturing practices has been tasked with assessing the facility and making recommendations to the NIH on required corrective actions. The NIH also plans to provide the FDA with an interim corrective action plan by June 19, 2015.