Let’s face it – when you were growing up – perhaps mostly in your teen years – you never really listened to your parents. You might have pretended to, or developed that uncanny ability to not really listen – yet be able to recite the last sentence of whatever was said. A great skill indeed.
Has anyone been listening to the FDA?
In 2004, the FDA proposed the idea of Quality by Design. According to an article in this month’s issue by Ron Snee, QbD’s purpose “was to design quality into the product and process rather than try to test quality into the product at the end on the production line. It has been known for a long time that “quality by testing” is a low-yield and costly strategy. In 2005 ICH outlined the concept of design space in its Q8 guideline that focused on product development. Since that time, pharmaceutical and biotech companies – despite depending on innovation for their livelihood – have been slow to adopt QbD.”
I mention this in light of the many recent recalls regarding quality problems at compounding pharmacies around the nation. As a subscriber to the FDA’s email alerts it’s quite sobering to read the almost constant stream of recall notices and tally up how many are related to quality control problems at compounding pharmacies.
The FDA, however, is not above reproach. Congressional hearings into the worst of the quality failures, the NECC case which lead to dozens of deaths from meningitis, has revealed that the FDA knew of the problems, but failed to act.
All of this leads me to my question – if these firms had listened to the FDA back in 2004 and implemented the recommendations proposed – would we even be in this situation?
Sometimes a little listening goes a long way – just ask your parents.