Will regulatory collaborations address some of these issues?
I would like to make sure that we are being strategic and cohesive globally in addressing criminal threats to the drug supply.
Whether it's counterfeiting or cargo theft or economically motivated adulteration, I think there's a real opportunity to make
sure that we take a holistic look. We need to make sure that the civil side out there monitoring facilities and the criminal
side catching criminals are talking so that we're able to both punish crime—and also prevent and detect crime by building
stronger regulatory safeguards and by telling industry what the risk might be and how to be proactive in protecting itself
from potential risks.
Another proposal is to do more to leverage third parties for conducting inspections. This has not been a big success at FDA
so far, so is it still promising?
It is true that the agency hasn't always had perfect results in relying on private third parties for inspections, but I think
that there is real potential there. We are further ahead in our exploration with respect to devices and foods, but I think
we've got what we need to get there on the drug side as well. This approach creates some real challenges, and we need to be
frank about those and to figure out how to overcome them.
For regulators, it's hard to let go and to let someone else help us. But given the realities of globalization, we just can't
do it alone. If we can work with others, if we can let go of control to some extent, we will have many more resources at our
disposal. We shouldn't walk into this blind to the downsides, but it is possible, and I believe we can get there.
Another recent report from the Institute of Medicine (IOM) recommended that FDA pursue 'mutual recognition' agreements of
inspection findings. Is that a realistic approach?
I believe that we need to look for 'mutual reliance.' That means sufficient comfort with each other's standards to be willing
to rely on work done by a counterpart. We don't necessarily need to go the whole way to mutual recognition agreements. I hope,
over time, that regulatory standards globally will converge, something that is already happening. As we work together, we
all learn from each other.
That IOM report also mentioned the Secure Supply Chain pilot program and greater use of low-cost technologies to oversee imports.
What role can those play?
The Secure Supply Chain is a pilot project that aims to facilitate imports from companies and facilities where we have a certain
level of assurance. It is in the process of moving forward and presents a risk-based concept: If you can know that certain
imports are low risk, then you don't have to devote much time to them.
We also see opportunities to utilize more low-cost technologies in dealing with imports and supply chain security. One example
is employing hand-held laboratory devices at the border. And in Africa there's use of a scratch-off number on a drug package
that you can text in and find out if the drug is authentic. Manufacturers also are using barcode technology on brand name
clothing or handbags and a call-in system to learn if the product is legitimate or not. I understand that certain large chain
stores have RFID tags on underwear, so it seems that there's potential for pharmaceuticals.