How does this affect biopharmaceutical manufacturers?
Industry needs to ensure that it has done everything it can to assume responsibility for its supply chains, for its component
suppliers, for its own production around the world. It comes down to companies really understanding what they're making and
what they're buying and how they can best ensure product safety and quality.
What changes have been made at FDA?
At around the same time that we issued the Pathway report, the Commissioner reorganized FDA. She established four directorates—the
Directorate of Foods and Veterinary Medicine, the Directorate of Medical Products and Tobacco, the Operations Directorate
run by our Chief Operating Officer, and my Directorate, called Global Regulatory Operations and Policy. My mandate is to implement
the Pathway report, to ensure that FDA fully integrates its domestic and international programs to best promote and protect
public health, and to make import safety and globalization a top priority in the years to come.
My directorate includes OIP, which leads, manages, and coordinates FDA's global engagement work, including our 13 foreign
posts. In addition, the Directorate includes ORA, which provides FDA leadership on imports, inspections, and enforcement.
My job is to take all of those resources and align them against our global challenges.
I think, for example, that we ought to be treating like risks in equivalent ways regardless of where they're located. So a
sterile drug facility in China should not be getting a different level of regulatory oversight than a sterile drug facility
in Chicago. If you look at reports from the Government Accountability Office (GAO), you'll see that our inspection coverage
on the foreign side is not nearly as frequent as our inspection coverage on the domestic side. Now, I don't think that means
that in the future we inspect everybody equally all the time. But we should have equal assurance of safety and quality regardless
of where the product comes from. And that can involve using our own inspections or data from our counterparts, or third-party
coverage, or any other means that we can come up with.
It's an interesting challenge because, as I said, we are a domestic organization. My directorate includes 4400 people in ORA,
pretty much all domestic; and less than 100 people in OIP dedicated to international work.
Does this mean that ORA will be shifting more inspectors overseas?
We're not necessarily spreading all our people around the globe, but we need to figure out how to use our resources to make
sure that we have the best coverage of all of our global risks. It's about strategic and risk-based global industry oversight.
We need to be gathering data and information, analyzing it, identifying risks, and devising targeted, tailored, strategic
approaches that are flexible, that address those specific risks.
Those approaches can be anything from inspections, to enforcement, to incentives, to education and training. We need to implement
those strategies, to see what works, and continue to learn and improve. Inspections are a significant part of it, but certainly
not all of it.
There also is a lot of work to be done in gathering information about emerging risks, whether it's product quality defects
or problematic environmental trends. It could be almost anything that helps us understand more fully the breadth of the risks
and how to intervene. Right now we, and a lot of regulators, have very operational models of doing business. We go out on
the ground and see what we find, and then we figure out what to do about it. That's important, but information can help us
know, in advance, what the challenges are, what the risks are, and what the opportunities are.
When you think about a world with hundreds of thousands of producers in 150 countries, that's such a monumental challenge.
The only way to really address it is to be as strategic and risk-based and leveraged as possible.