FDA Adopts New Strategies to Oversee Global Economy - Pharmaceutical Technology

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FDA Adopts New Strategies to Oversee Global Economy
A Q&A with FDA Deputy Commissioner Deborah Autor.

Pharmaceutical Technology
Volume 36, Issue 7, pp. 26-34

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,


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