The transcript of Nasr's plenary speech follows. Click here to hear an audio file of Part 1 of this speech, and click the Download Now button at the end of the speech transcript to access the "Part 2" audio file.
Good morning and thank you. This is my fifth time at IFPAC. Im here to make it very clear that we at the Agency are committed to the continuation of our initiatives in pharmaceutical manufacturing and PAT.
I will focus on how these activities relate to the initial premise of advancing science-based pharmaceutical manufacturing. Theres a unique opportunity at IFPAC, since pharma is only one section of many here, and there is an opportunity to learn from those in other industries about other approaches [to applying PAT concepts].
Id like to share with everyone my own perspective on where we are today as it relates to pharmaceutical manufacturing.
I want to:
- make it clear how we define the design space;
- discuss pharma quality initiatives as a subset of the Critical Path;
- focus on QbD and how the PAT initiative hits QbD; and
- share with you where we are today.
The industry is under attack today The question is: are [drugs] affordable? Should we worry? There is a lot of discussion in Congress regarding Medicare and purchasing strategies. In short, there are a lot of challenges facing industry.
What about us as an agency? Theres quite a bit of public concern
In the last couple of years, more so than before, this is highly visible the high cost of pharmaceuticals, will we be able to monitor drugs after approval? There is resistance to importation from Canada and outside the U.S., and there are other issues regarding specific drugs.
Resources are very tight. [But we must ensure the] adequacy of expertise for every change in science in technology. We need expertise and it is very important that we have the right staff and expertise [for our programs]. We cannot expect industry to provide us with this info
We have been working tirelessly over the past few years to ensure international harmonization [of regulations]. Theres discussion about variations as they relate to manufacturing changes. Were involved in quite a few activities.
But there are still a lot of public concerns. There are unmet medical needs, questions about costs, managed care issues, insurance questions, the issues of counterfeit drugs, questions about the safety of importation. And there are public opinion issues, along with drug safety, speed of drug approval, perceived lack of enforcement (at times), criticism about approval times, and questions about our relationship with the industry.
So where are we today with pharma manufacturing? The industrys level of quality is adequate. But QA can be quite painful, and in general, drug manufacturing is not as innovative and efficient as other industries.
Manufacturing is expensive and efficiency is not as high as it could be. Here is low factory equipment utilization.
And amazingly, theres quite a bit of reliance on FDAs regulatory oversight. This industry is too reliant upon the FDA. We dont like that and dont want the seat of power to be with us. We think that industry should be empowered to manage most of its QA and QC functions.
In short, the bottom line is that our industry not as innovative and efficient as other high-tech industries. It is overly conservative, and there is a lack of coordination between key business units.
These challenges impact PAT. Since weve recommended harmonization, its challenging. We see frequent manufacturing failures and more reliance on outsourcing.
And that reliance, in itself, becomes more challenging, not only because of our concern about the well-being of the U.S. pharmaceutical industry, but because of the Agencys limited resources, and our ability to reach beyond our nations borders to ensure that GMPs being implemented.
A recent report by George Washington and Washington Universities found that this industry wastes $50 billion each year because of lack of manufacturing efficiency. Think of how that money could be used to develop drugs that could meet unmet medical needs, and potentially, to reduce the cost of pharmaceuticals in our country.
So where are we with our Desired State? Dr. Woodcock spoke about the meeting in Washington, where we defined the Desired State for agency and industry. Simple definition indicates where we need to move: to maximum efficiency and flexibility in drug manufacturing, producing products of high quality without extensive oversight.
This sounds simple, but is difficult to do. In order to get there, we need three pieces:
- Quality By Design (QBD), as spelled out in ICH Q8;
- Robust, reliable pharmaceutical quality systems, as spelled out in ICH Q10;
- The use of quality risk management tools as in ICH Q9.
The harmonization efforts and efforts within Agency on Q8-10 will take us where we need to go to reach the desired state. This effort is very tedious, difficult, even painful at times, but the only way to move forward.
So, where are we with pharma quality initiatives, QbD and PAT?
In September 2004, we published the 21st Century Quality Initiative and also issued the PAT guidance document.
This guidance came after almost two years of intensive efforts by FDA's hardworking PAT team, of which Im proud to have been a member...
Weve been working on ICH made quite a few changes in our office. We had some challenges with our generics review process, came up with question based review.
We also finalized quality systems guidance. We held a workshop in 2005; thats where Janet spoke on the final Desired State.