June 5, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – The National Institutes of Health Clinical Center suspended operations of its Pharmaceutical Development Section after two vials of vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination, the federal agency said Thursday afternoon.
In April, two vials made from the same batch were administered to six patients, however the National Institutes of Health (NIH) said it is not known whether those or other vials were contaminate by the fungus. The six patients have been notified and are being followed closely for any signs of infection, although at this time none of the patients has shown signs of infection or illness, the NIH said.
However, 46 additional studies have been potentially affected. There are more than 250 patients who were expected to participate in the studies who were expected to receive products manufactured by the PDS The National Institute of Health said is in the process of notifying the scientists and patients participating in these studies.
“The vast majority of these patients are not immediately due for treatment and NIH is working to secure alternative sources for the products,” the NIH said.
The manufacturing and compliance problems were discovered over a 10-day inspection period in May following a complaint filed with the U.S. Food and Drug Administration (FDA).
Among the problems the FDA identified in their inspection were deficiencies in the “physical facility, including flaws in the air handling system, and operational failures including inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures.”
NIH Director Francis S. Collins called the situation distressing and unacceptable. Collins said protecting patients are the first priority of the NIH.
“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 Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible,” Collins said in a statement.
Operations at the facility have been suspended until all problems are corrected. Materials produced at the site are being tested for additional contaminations. The Pharmaceutical Development Section makes products for certain clinical research studies conducted in the hospital and collaborating facilities.
NIH said it will provide the FDA with an interim corrective action plan by June 19. Corrective actions will include using a team of external experts in microbiology and sterile manufacturing practices.
The NIH treats patients with rare diseases at its 240-bed hospital. Patients in the clinical trials are receiving experimental or commercially available drugs that need to be prepared in specialized doses, the Wall Street Journal reported.
When Will Pfizer’s Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.
Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.
Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.
“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016,” said Chris Schott, an analyst at J.P. Morgan. “Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile.”
BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?
