Eschenbach offers 'Andy's Take' on FDA issues

Eschenbach offers 'Andy's Take' on FDA issues

The ever-growing blogosphere has a new voice--none other than FDA commissioner Andrew von Eschenbach. At Andy's Take [1], Eschenbach offers an unprecedented look into the mind of the FDA's top official, which could give drugmakers and analysts insight into major issues affecting the industry. "I want to give you my take on the changes at the FDA and what we need to do to improve and be responsive to the rapidly changing world around us," states Eschenbach in his inaugural post.

Eschenbach's blog comes at a time when the FDA is under attack from all sides--the agency is dealing with staffing shortages, drug safety, complains about its overly-conservative approach to drug approval, missed PDUFA dates, and an anemic budget. Why is the FDA missing deadlines [2]? What's with all the approvable letters [3]? Why are some promising drugs shot down [4] while others sail through [5] the approval process? We'd all like to know, and it would be great to get feedback from the man himself on these issues.

The first topic Eschenbach tackles is the ongoing heparin dust-up. Eschenbach frankly admits that even if inspectors had examined the right plant (they didn't [6]), they wouldn't have detected the contamination.

"…Our records error on the inspection emphasizes our need to accelerate the improvement of our data systems and computerization of all our records with internal checks and back-up verification…[N]o test we use will ever be 100% reliable, and we cannot rely only on inspections. We need a systems approach to quality that not only enables us to react effectively to problems but enables us to prevent problems by engaging FDA across the entire lifecycle of the products we regulate."

With all the criticism the agency has faced, I'm glad to see Eschenbach take a stab at transparency and attempt to explain just what the FDA's agenda is these days. One hopes that the Commissioner uses this opportunity to provide valuable explanations for the FDA's actions and plans. It will be disappointing if Andy's Take devolves into a just another PR outlet, or a place for Eschenbach to complain about criticism. A frank discussion of the agency's problems will help drugmakers understand the regulatory environment and how it impacts their business. Just don't expect to ask Eschenbach anything directly--readers can't comment on blog posts.

What do you think of the Commissioner's new blog? Email me [7] your thoughts. - Maureen [7]