At this week's IFPAC conference, FDA's Chief Medical Officer, Dr. Janet Woodcock, told drug manufacturers that they need to worry more about their customers, about patient safety and customer service, than on what regulators are going to say about their facilities or applications.
That's still easier said than done for many pharma companies.
A recent survey of about 50 drug manufacturers, including some of the largest, by Aberdeen, corroborates this point. When asked what motivates their traceability and compliance initiatives, 96% responded "regulatory bodies."
What are the top three factors driving your companys compliance and traceability programs?
Regulatory bodies 96%
Customer requirements, ISO 51%
Consumer safety 51%
Competitive advantage 38%
Reduce cost of recalls 15%
Reduce costs of audits 13%
Which raises the question: if regulatory bodies weren't so demanding, what would they be doing? Would they operate on the honor system? Now that FDA's moving from the old "command and control" system, will more manufacturers rise to the challenge? There are reasons for this "disconnect" between drug makers and their patients, and they could fill volumes. But eliminating it may just be the key to healing the industry, repairig its public image, and ensuring that it survives the turbulent times ahead. Stay tuned for an analysis of the survey results by Abderdeen's analyst Matthew Littlefield in February's issue of Pharmaceutical Manufacturing (and online). -AMS
