From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Watchdog Report: FDA’s Oversight of Drug Imports and Foreign
Inspections

Audio interview by GAO staff with Marcia Crosse, Director, Health Care

Related GAO Work: GAO-10-960: Food and Drug Administration: Overseas Offices
Have Taken Steps to Help Ensure Import Safety, but Long-Term Planning Is Needed
/ GAO-10-961: Drug Safety: FDA Has Made Limited Progress in Conducting More
Foreign Inspections and Improving Its Information on Foreign Establishments

Released on: October 25, 2010

[background Music]

[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the Government Accountability Office. It's October 20, 2010.
The Food and Drug Administration, or FDA, uses inspections and other measures to
help ensure the safety of drugs, medical products, and food coming from
overseas. Two groups led by Marcia Crosse, director in GAO's Health Care team,
recently evaluated the FDA's efforts in these areas. GAO's Jeremy Cluchey sat
down with Marcia to learn more.

[ Jeremy Cluchey: ] GAO has looked at FDA's inspection of foreign drug
manufacturing establishments several times over the years. Can you talk a little
bit about how that inspection process has changed?

[ Marcia Crosse: ] Well, we have looked at it several times. For more than a
decade, we've checked periodically on what's happening in this process, and what
we see across time is increasing globalization of drug manufacturing. The volume
of products manufactured overseas has been increasing throughout this time, and
it also has particularly been increasing in developing countries. We see a lot
more manufacturing of drug products in India and in China.

[ Jeremy Cluchey: ] How many foreign inspections did FDA conduct last year? And,
then, how does that compare to their domestic inspections?

[ Marcia Crosse: ] The most recent year we looked at, which was their fiscal
year 2009, they did 424 inspections of foreign drug establishments. That's an
increase of about 100 inspections over the prior 2 years, but it's really only
about 11 percent of all of the facilities that are on FDA's list of
establishments. And that means that they only get to these establishments about
once every 9 years. When you compare that with the domestic inspections,
domestic inspections were over 1,000 and they inspected about 40 percent of
domestic establishments. They get to those about once every two and a half years
in comparison to once every 9 years overseas.

[ Jeremy Cluchey: ] Can you talk about any steps FDA is taking to improve its
foreign inspections process?

[ Marcia Crosse: ] Well, they are doing a number of things. Since we had
previously reported on this process, they have established a dedicated cadre of
inspectors to do foreign drug inspections. And so they now have some staff that
they can rely upon to do these. They're also working to get more accurate data
about the establishments. They're implementing an electronic registration system
so that they have better data about which facilities actually are shipping
products to the United States. And they're working to achieve a unique
identification number for each facility so that they have more accurate data
about whose products are coming into the country.

[ Jeremy Cluchey: ] You mentioned that FDA now has a dedicated cadre of staff to
oversee foreign inspections. And GAO also looked at FDA's recently established
overseas offices. To what extent did your team find that these offices are
having an impact on the safety of imported products?

[ Marcia Crosse: ] Well, I think it's very early still to say what impact
they're having. The first office was opened in China less than 2 years ago. So,
in these first couple of years, they've really focused on establishing
relationships with foreign regulators and with foreign industry. Because the
U.S. is an attractive market and there are many companies that want to ship
products to the United States, they need to understand what the expectations
are, what the requirements are. So they've spent a lot of time answering
questions and doing presentations to industry. They're also spending a lot of
time trying to get to know their regulatory counterparts so that they have an
idea of who to go to for what. One example of that is in India the food products
are regulated by many different agencies, including some trade councils. And
they really didn't have a good understanding of that before they had offices
overseas in India and an ability to get to know these people and to know what
part of an industry is regulated by whom.

[ Jeremy Cluchey: ] And what is GAO recommending that FDA do to enhance the
effectiveness of its overseas offices?

[ Marcia Crosse: ] We're making two recommendations. First, we're recommending
that FDA take steps to enhance their strategic planning to ensure the
coordination between the overseas and domestic activities. This is essential
because the staff in the overseas offices are still not really clear on what
information is most useful to the folks back here in headquarters and what's
happening with the information that they sent back. The second recommendation
that we're making is that FDA develop a workforce plan to help recruit and
retain the overseas staff.

[ Background Music ]

[ Narrator: ] To learn more visit GAO's Web site at gao.gov and be sure to tune
in to the next edition of GAO's Watchdog Report for more from the congressional
watchdog, the Government Accountability Office.