BioPharm: 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?
Autor: 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.
BioPharm: Another recent report from the Institute of Medicine (IOM) recommended that FDA pursue "mutual recognition" agreements of
inspection findings. Is that a realistic approach?
Autor: 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.
BioPharm: 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?
Autor: 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.
BioPharm: There's another IOM report coming on counterfeit drugs; what is its focus?
Autor: We asked IOM to address the gaps globally in dealing with SSFFC drugs—substandard, spurious, falsely-labeled, falsified, and
counterfeit products. How can countries and other stakeholders come together to really ensure that we are doing the best job
we can in dealing with those products? Often that discussion gets mired in intellectual property issues.
BioPharm: Should we be looking for more reports on globalization from your office and more FDA foreign offices?
Autor: I think our job now is to bring the current program to life. I don't think we know, at this point, exactly what our global
presence will be over time. Our foreign offices have been key to enhancing our effectiveness overseas, helping us to know
our counterparts, to understand them, to gather information about emerging issues, and to be there when we need to jump in
and do an inspection quickly.
We may get additional money in the 2013 budget for more inspectors in China for food and drugs. And if the Generic Drug User
Fee Act is enacted, we will have a lot of responsibilities to expand foreign inspections and will need to take a hard look
at how we can meet those. At the moment, we don't have any concrete plans to open new offices, but over time, we'll have to
see what we need to do.
BioPharm: How will FDA be different in 5 to 10 years?
Autor: I believe that we will be more data driven, more risk-based, more strategic, more leveraged. We will be collaborating with
our counterparts in global coalitions, we will be using data and advanced risk analytics, and we will be working closely with
public and private third parties.
The combination of difficult economic times and quantum leaps in globalization will drive us towards being smarter and more
effective and leveraged. I think that we will recognize that, given the challenges we and our counterparts all face, we can
no longer afford duplicative regulatory programs; we need to find ways to work together as much as possible.