Quality Control & Fungal MeningitisSubmitted by CSA1861 on Fri, 03/08/2013 - 11:39
Help me understand the incentive for low quality in a regulated industry.
I understand the false sense of security that government approval of drugs creates, but please help me with this specific case. I'm doing a presentation on the fungal meningitis outbreak from last year. In case your state was not affected, New England Compounding Center sold thousands of vials of contaminated methylprednisolone for epidural injections to hospitals & clinics across the country. Compounding pharmacy falls under state regulation - therefore, they were licensed by Massachussetts and any boards of pharmacy of states they sold into. Drug manufacturing is overseen by the FDA, the difference mainly being volume of production, interstate commerce, and that compounders make products for specific prescriptions from doctors they have a relationship with where as manufacturers make product in bulk.
Under those definitions, NECC was acting illegally as a manufacturer while licensed as a compounder, therefore they escaped FDA quality control regulations. The FDA can react to problems in compounding pharmacies, but cannot proactively investigate them before problems are reported. Of course, now the Feds are pointing at NECC and saying "AHA! THAT is why you need us to oversee compounders as well!"
I see the answer to this being similar to the horsemeat problem in Europe and black market illicit drug trade: Why do privately owned market participants make poor quality products when outside of the legal regulatory apparatice?