U-M researchers discuss how a recent fungal meningitis outbreak has brought to light quality control issues at compounding pharmacies. Professors Kotov and Wang explain how a combination of better oversight and easier testing methods could ultimately help prevent issues like this in the future.
ABOUT THE PROFESSOR: Henry Wang is a professor of Chemical Engineering and Biomedical Engineering at the University of Michigan. His research interests include the global healthcare sector, comprised of pharmaceutical, biotechnology, medical device companies, regulatory agencies such as FDA, healthcare providers, insurers and consumers.
Nicholas A. Kotov is the Joseph B. and Florence C. Cejka Professor of Engineering. He is committed to engaging in the “most creative, forward looking, and unorthodox scientific and engineering discoveries.” He runs The Kotov Lab at the University of Michigan.
As former head of manufacturing of two major pharmaceutical companies that bent over backwards to assure the quality of their sterile injectible products, I see no justification for allowing compounding pharmacies to prepare such products unless suitable products are not available from FDA authorized manufacturers and the products are approved for their indicated use by the FDA.
The system of redundant requirements established by the FDA to assure sterility of parenteral drug products in the pharmaceutical industry is adequate. Starting from the system design, then there are controls established for commissioning, installation qualifications, operation qualification, performance qualification, process validation, continuous process verification, container closure verification, filter bacterial retention validation, terminal sterilization (autoclave) validation, steam in place validation, etc. Then there are required controls for operating and maintaining sterile suites. This technology is mature and effective. It is used with superior success in the electronic component manufacturing. The deficiency related to this recent event is obvious. Compounding labs and hospital pharmacies are authorized to make parenteral drug products without any of the aforementioned controls. The risk to public safety has been known for years. The FDA does not regulate such labs. It is a glaring gap. Another such gap is the regulation of drugs in distribution where there is little accountability. Another gap is with dietary supplements. My hope is that the people that have died and will die due to this failure will force regulation in these areas. How many people have to die at an intersection before we add a traffic signal? We are about to find out.
That’s a crackerjack answer to an intreestnig question