Plans for the new quality super office where announced by Food and Drug Administration (FDA) Commissioner Margaret Hamburg in a blog post published during her trip to India earlier this month.
FDA spokesman Stephen King told in-Pharmatechnologist.com the office “will align all of the drug quality work into one super-office, so that we have an expertise-based organizational structure, rather than having various quality functions spread throughout the Centre.
However, further details were unavailable as the office is still in its infancy, though according to King the agency is “on track” and “working to finalize the proposal so that it can be reviewed and signed off on by the appropriate offices.”
Quality was a big focus of Hamburg’s trip to India, with recent good manufacturing practices (GMP) violations at companies like Ranbaxy and Wockhardt, being cited by observers as a driver for the FDA’s decision to deploy more inspectors in the country.
However, recent quality problems were not a major motivation for development of the new office according to King, who pointed out that: “Foreign manufacturers have always had to comply with our GMPs if they wish to market finished products or sell ingredients for finished products within the US.”
Whilst the ‘super-office’ will re-align all drug quality work carried out across Center for Drug Evaluation and Research (CDER) offices the focus “won’t change in relation to it being more focused on international operations vs. domestic ones.”
This was confirmed by one close observer of the FDA’s activities who told this publication “the move to upgrade the pharmaceutical quality function has been going on for at least a couple of years.”
He continued: “Reorganizations of this type take time and a lot of clearances. So the FDA’s announcement is not—in my opinion—related to the recent uptake in overseas GMP violations.”
The FDA’s thirst for streamlining and consolidation has seen it recently rejig its Office of Generic Drugs (OGD), elevating it to the status of a ‘super-office’ housing subordinate offices focused on standards, bioequivalence, policy and regulatory operations for generic drugs.