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

Transcript for: FDA Oversight of Foreign Drug Safety 

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

Related GAO Work: GAO-17-143 Drug Safety: FDA Has Improved Its Foreign
Drug Inspection Program, but Needs to Assess the Effectiveness and
Staffing of its Foreign Offices

Released: January 2017


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[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the U.S. Government Accountability Office. It's January
2017. As more drugs are manufactured overseas, FDA's oversight of drugs
in the United States is getting more complicated. FDA reports that more
than 40 percent of finished drugs and 80 percent of active
pharmaceutical ingredients are produced overseas. A team led by Marcia
Crosse, a director in GAO's Health Care team, recently reviewed FDA's
oversight of foreign drugs. Jacques Arsenault sat down with Marcia to
talk about what they found.

[ Jacques Arsenault: ] A lot of the drugs that are sold in the United
States are produced overseas. Can you explain how does FDA make sure
that they're safe?

[ Marcia Crosse: ] Yes, you're right a lot of the drugs are made
overseas. About 80 percent of the ingredients in drugs, and about 40
percent of the finished drugs are actually produced overseas, and
imported into this country. And the main approach that FDA has for
making sure that the drugs are safe is actually going and physically
inspecting the manufacturing facility to be sure that all of the safety
and quality standards are being maintained at that facility, so that the
drugs that are being produced are exactly to specification. There are a
lot of facilities, and increasingly those facilities are overseas, so
FDA has been moving to do more of its inspections overseas. Of course,
the manufacturers have some responsibility for ensuring the safety of
their drugs, after all, they're the ones selling the product. But FDA is
there as an important safety check to be sure that drugs are safe and
effective.

[ Jacques Arsenault: ] And can we say whether FDA is doing a good job of
monitoring these drugs?

[ Marcia Crosse: ] I would say that they are doing a lot more to monitor
the safety of the drugs than they had been at one time. Now, they are
actually employing a risk model that lets them determine which
facilities they should go to on what schedule. In the past, they were
going just kind of on a regular schedule, but some drugs are more
difficult to make. And to be sure that they're making their
specifications, and we want to be sure that FDA is going more frequently
to those facilities than to places that are making easier to manufacture
drugs, and places that have had a good, clean inspection history. So FDA
now has a model that looks at the risk of the facility, and its
inspection history to try to decide where to go to when.

[ Jacques Arsenault: ] One of the things I noticed in your report is,
you also looked at FDA's foreign offices. And it sounds like FDA doesn't
seem to know if having these foreign offices is helping them monitor the
drugs. Can you tell me a little more about that?

[ Marcia Crosse: ] Yes, FDA first established these offices in 2008 in
part because of this trend to globalization in manufacturing. It's true,
they're not really doing a good job of tracking what it is that these
offices are contributing. They do think that they are helping, they have
people now in-country to observe what kinds of conditions are going on
to be able to identify facilities. They also do some of the inspections
with staff based in these offices, and the staff in these offices also
do a lot of outreach to the manufacturers, and the drug industry in
those countries to help them understand what the standards are and what
FDA's expectations are, so that they're better able to meet the
requirements. But we felt like they were not doing enough to really
track what the contributions are.

[ Jacques Arsenault: ] Now this isn't the first time that GAO has looked
at FDA's oversight of foreign drugs, and it sounds from our conversation
like some things have changed. Have things improved, or are we basically
seeing some of the same problems and challenges?

[ Marcia Crosse: ] I do think things have improved. They're doing a lot
more inspections overseas. In fiscal year 2015 for the first time they
actually did more inspections of foreign facilities than of domestic
facilities. And that's important, because there are more foreign
facilities. That's an improvement that the rate of inspection has
shifted to where the manufacturing is. They also are getting to places
that they hadn't been to before, but we do think there's a problem in
that, there are still at least one-third of the facilities that they
don't have an inspection history for. They can't say if they've ever
been inspected, or if it's been more than 10 years since they've been
there. And so, they, you know, part of the model that I mentioned is
that they look at the inspection history. On a third of the facilities
they don't have an inspection history, and so I think that is still a
continuing problem.

[ Jacques Arsenault: ] So, then can you talk about the recommendations
that GAO is making in this report?

[ Marcia Crosse: ] Yes, well, we didn't make specific recommendations
about the one-third, because they do have a plan to go to those
facilities in the next 3 years. They are trying to rapidly get through
the facilities that they haven't been to. But, as I mentioned, we think
there's some problems with assessing the contributions to the foreign
offices, and so we're recommending that they actually take further steps
to asses those contributions by systematically tracking information to
measure whether the activities of the offices are specifically
contributing to the safety of the drug products. You know, not just look
at how many inspections they've done, but what the impact of that has
been. The other thing that we think is important for them to do, is to
look at the staffing of these offices. They have had a chronic problem
in being able to fill the position in these offices. And so, we think
it's important that they establish some goals to achieve the appropriate
staffing levels for the offices. To do that by looking specifically at
each location, and what kind of staff and what mix of staff they need.
Because right now, they have almost half of those positions are vacant,
and we think they need to fill them if the offices are going to be able
to be effective.

[ Jacques Arsenault: ] And finally, what would you say is the bottom
line here?

[ Marcia Crosse: ] I think that the bottom line for us is that they're
-- FDA is still catching up with the globalization of manufacturing.
They've come a long way, they've actually made a lot of progress over
the time we've been looking at this, but they still have some areas
where we think they need to improve in order to be sure that drugs
manufactured overseas, are just as safe as the drugs that are
manufactured in the United States.

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