The National Institutes of Health (NIH) has announced in a statement that two research facilities are closing after patient safety has been compromised in sanitary standards. This comes as a response to a previous sanitary scandal involving the NIH.
In April 2015th the NIH was involved in a scandal when two fungal contaminated drugs were given to patients involved in the researches. Since then the NIH has been working on bettering work conditions in certain facilities.
Reviewing all NIH facilities to protect patients
The National Institute of Health is a part of the United States Department of Health and Human Services, in charge of medical research to make new discoveries in health and disease issues.
Throughout a press release published on their website, the organization announced the closure of two research facilities: The National Cancer Institute laboratory that works with cell therapy production and the National Institute of Mental Health facility that specializes in producing PET materials.
The shutdown of this facilities comes as a response to a fungus scandal that affected the organization last year when a fungal contamination was discovered in two drugs manufactured by the Clinical Center’s Pharmaceutical Development Service.
The contaminated drugs were given to research patients in the facility, at least six subjects received the drug, yet no one was affected by the batch of drugs.
NIH’s campus in Bethesda Maryland was the location where government inspectors found the contaminated drug, officers assured the contaminated drug was a result of poor manufacturing practices by the facility.
After the batch was found a series of monitoring and inspections was held to the NIH, inspectors from the US Food and Drug Administration (FDA). Investigations took place between May 9th and 29th since the anonymous complaint had been made as well.
After the scandal, the NIH launched a “multifaceted effort to ensure that processes for patient safety and quality of care at the hospital are of the highest standards” according to the organization, who hired two different companies in charge of assuring quality in the manufacturing and compounding of the drugs.
Both of this company in their preliminary findings identified the mentioned facilities assuring they didn’t meet the suitable quality and safety standards to manufacture drugs. So the NIH decided to shut down the facilities. The organization assures that patients and research are still their main priority.
“The is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken. NIH will not enroll new patients in affected trials until the issues are resolved” Said the NIH in their press release.
Source: NIH