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

Transcript for: Public Health Threats from Prescription Drug Shortages 

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

Related GAO Work: GAO-14-194: Drug Shortages: Public Health Threat
Continues, Despite Efforts to Help Ensure Product Availability
 
Released: February 2014

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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
February 2014. Drug shortages have caused prolonged illnesses, permanent
injuries, and even deaths. As a protector of public health, the Food and
Drug Administration has been working to prevent, alleviate, and resolve
drug shortages. A team led by Marcia Crosse, a director in GAO's
Healthcare Team, recently examined trends and causes of drug shortages,
and FDA's progress in addressing them. GAO's, Sarah Kaczmarek, sat down
with Marcia to talk about what they found.

[ Sarah Kaczmarek: ] Your team looked at trends in recent drug
shortages, what did you find, and what's the effect on patients?

 [Marcia Crosse: ] Patients can be harmed if they're not able to get the
medicines that they need, and we have found, in some instances, that
drugs in shortage are completely unavailable or they may not be
available to give to a patient as frequently as a doctor might desire,
for example, chemotherapy drugs might be in shortage. So someone may not
be able to get their treatment as frequently as they should. This can
cause serious problems for patients, because they can't get treated as
quickly as they should. They may have to delay their treatment
altogether, or they may have a different drug substituted that's not as
effective for them.

[ Sarah Kaczmarek: ] And what's the cause of this problem?

[ Marcia Cross: ] Well, there are a number of causes. The primary cause
is when drug manufacturers suffer some quality problem at their facility
that could cause them to actually stop production or to reduce
production of the drugs on their line. Because there are only a few
manufacturers making most drugs, there often are not other companies
that can take up the slack, that can step in and produce more of that
drug so that the supply is maintained. And so, this can have a cascading
effect with multiple companies making drugs, but not making enough of a
particular drug.

[ Sarah Kaczmarek: ] How's FDA doing, then, in addressing these
shortages?

[ Marcia Crosse: ] Well, we think that FDA has had some improvement
since we last reported on this problem in 2011. As we had recommended,
FDA was given some additional authority to require manufacturers to
report to them sooner if they were going to stop manufacturing of a drug
or if they were having a problem that would lead to a shortage, and so
that's helped FDA to plan and to try to take some actions in advance
that might avert or reduce the duration of a shortage. So that's been
good. The actual number of new shortages has gone down somewhat in the
last year. However, many drug shortages are persisting, and we found
that FDA still doesn't have good data on drug shortages to help them
manage this problem.

[ Sarah Kaczmarek: ] Given the challenges here, what's GAO recommending?

[ Marcia Crosse: ] Well, as I mentioned, FDA's data, we think, are still
not sufficient to really help them understand some of the underlying
causes and to monitor what's going on, and so we're making some
recommendations to FDA to, to strengthen their drug shortage data, and
to conduct periodic analyses of the data that they have, and we think
that could be a benefit. That, in and of itself, will not resolve the
drug shortage problem, but we think it can improve some of the actions
that FDA can take.

[ Sarah Kaczmarek: ] Finally, for taxpayers concerned about this serious
public health threat, what's the bottom line here?

[ Marcia Crosse: ] Well, drug shortages are a serious problem. There are
critical drugs that go into shortage every year. I think it hasn't been
recognized as much in the past, but now the federal government has begun
to put more resources into this area, to take some additional actions,
and to give FDA some additional authorities, but it's still a long-term
problem that's going to take concerted action on the part of industry,
as well as FDA, in order to resolve this concern.

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[ Narrator: ] To learn more, visit GAO.gov and be sure to tune in to the
next episode of GAO's Watchdog Report for more from the Congressional
Watchdog, the U.S. Government Accountability Office.