PharmTech:
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.
PharmTech:
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.
PharmTech:
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.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
.
|
