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

Transcript for: AskGAOLive Chat on Prescription Drug Shortages

Description: Online video chat 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


>> [Background Music] Welcome to AskGAOLive. 

>>Welcome everyone to AskGAOLive. Thank you so much for taking the time
to tune in and join us today. My name is Sarah Kaczmarek. I'm in our
Office of Public Affairs. I'm joined today by Marcia Crosse, a director
in GAO's Health Care team. Thanks so much for joining us today.

>> Thank you.

>> Today we're going to be talking about prescription drug shortages and
GAO's recent work on this. For context, you can find Marcia's recent
report on this, it's GAO-14-194. It's right on our website, gao.gov. You
can either search for the report number, again, that's GAO-14-194 or you
can browse for it under Reports and Testimonies, looking for the reports
that came out on Monday. Before we get started, let me talk about how
you can send in your questions. We've already gotten a few questions
over e-mail. The e-mail address is AskGAOLive@gao.gov. For those of you
on social media today you can also send in your questions on Twitter,
just use the #AskGAOLive. So we'll be keeping an eye out during this
whole chat for your questions and comments and we'll do our best job to
get you a response today. So Marcia, as we get started could you give us
an introduction to yourself and your work at GAO?

>> Certainly, I am one of the directors in GAO's Health Care team. I'm
responsible for a range of our public health work including our
oversight of FDA medical products and our public health preparedness
work.

>> Great, and so let's talk a little bit about our topic today Marcia,
prescription drug shortages. Could you give us an overview of your
team's recent report on this?

>> Yes, we issued a report, as Sarah said, just on Monday, looking at
shortages of prescription drugs. This has been an increasing problem
over the last decade and prescription drugs are critically important for
medical care. We've seen shortages of drugs to treat trauma patients, to
control pain during surgery, to treat cancer and heart disease and to
provide nutrition support to premature infants for example. And the
shortages have really impacted patient care and the way in which doctors
are able to provide the necessary treatments for their patients.

>> And this sounds like a really critical problem, so what prompted
GAO's review of this?

>> Well, GAO was required by the FDA Safety and Innovation Act to
prepare this report. We had previously reported in 2011 on drug
shortages, and Congress wanted an update on what had happened since they
had given FDA some new authorities, and it placed some new requirements
on the agency.

>> Great, I'm going to take our first question from the audience. The
question comes from Ron over e-mail and Ron would like to know, did GAO
look at the Accelerated Recovery Initiative, and has the initiative had
an impact?

>> We did talk with the Generic Pharmaceutical Association about this
initiative that they have in place. When we spoke with them last in the
fall, as we were completing our work that was still in an early phase.
They had a process in place to try to identify certain shortages for
their pilot program but at the point at which we completed our work I
would not say that it had yet had an impact. It was too soon to really
see what was going to flow from that.

>> And our next question comes from Bob over e-mail. Bob would like to
know, it appears the FDA has improved its response to shortages armed
with new tools from FDASIA.

>> Yes.

>> What are the most severe shortages today?

>> Yes, FDASIA, the Food and Drug Administration Safety and Innovation
Act did give FDA in particular it gave them an ability to require
companies to provide advance notice. So that they had to tell FDA
further in advance when they expected to have to take a production line
down for maintenance, or if they were going to cease producing a drug or
some other issue that they thought would lead to a shortage. So this
advance warning has actually enabled FDA to get a head start so that
they've been able to prevent many more shortages or to work so that they
could more quickly resolve a shortage should one actually occur. So
that's been a positive result. We do see that the number of new
shortages has been decreasing in 2012 and again in 2013. And so that's a
very positive trend. Unfortunately the number of ongoing shortages has
continued to increase across this whole period and I think we have a
figure that we may be able to put up on the screen, the first figure
that shows the overall trend of what's happened to drug shortages during
this period of time. You'll be able to see that the number of new
shortages is decreasing but the number of ongoing shortages is still
relatively high and at the highest level across the span we examined.

>> And Bob has a follow-up question for this. He asks, have you reviewed
the business contractual relationships between manufacturers and
suppliers or consumers that yield both predictability of price and
demand for pharmaceuticals, and has this helped in any regard?

>> Well, we're not able review the private business arrangements that
distributors and hospitals for example, may have in place. We have not
looked at that. We looked at a number of studies that have been done to
try to understand some of the underlying causes of shortages, to sort of
see what some of the economic issues are. We're planning to continue
work. We're just starting now with further work where we expect to
examine some of the underlying economic factors in greater depth and we
hope we'll be able to get a little more into what some of the business
practices are.

>> Great. And in this current review, what did you find in terms of what
FDA was doing to address shortages?

>> Well, as I previously mentioned, FDA is taking more action up front
because they're getting earlier notice. We also found that FDA has
increased the number of staff that they have assigned to work on drug
shortages. That was a concern we had raised when we reported in 2011.
FDA has substantially increased that drug shortage staff and they've
been able to provide more direct assistance and to be able to have
identified individuals to work with a company on a particular shortage
and that's been very helpful. And you know, industry has told us that
that's greatly appreciated. They also have developed a database, just
starting in 2011. They began to put information into a database that we
believe will in the future provide them with more information to better
be able to understand what's going on in some of the trends.

>> And we're going to take another question now over e-mail that came in
from Curtis. Curtis would like to know, he says, economic data suggests
that health care costs are rising particularly in the area of
pharmaceuticals. How can we have hospitals confront this challenge while
ensuring stable product is available for patients' needs?

>> Well, as I said, understanding some of the underlying economic
factors is something we hope to do more work on. A lot of the drugs that
are in shortage are ones that are used in in-patient care so many of
them are drugs that hospitals have to purchase. Under many arrangements
with insurance companies or with Medicare those drugs are covered as
part of a bundled payment and so it's not as though the individual drug
is being billed directly for what the hospital has paid for it. We're
still trying to get a handle on how some of these dynamics work because
this is not sort of a normal consumer market where you would expect that
increasing demand would lead to an increasing supply. That's not
necessarily working in this market because there are a lot of other
players that have a control.

>> And we have our first question in from Twitter and again, if folks
want to send in questions on that, it's #AskGAOLive. So @HSCA asks on
Twitter, is GAO reviewing the FDA notion of increased quality measures
for manufacturers such as a grading system for quality?

>> We have looked at that. We did review the information and talked to
FDA about that. I think it's something that's very difficult to
implement because FDA has actually worked very hard to try to make the
point that if a drug is approved by FDA then it meets quality standards
and so I think it's a difficult path to walk to try to differentiate. It
is something that's true that companies told us as well that there's not
necessarily an economic reward for an increase in quality and so we
think there's some merit to the idea but how that could actually be
implemented is not at all clear.

>> So, we're going to take a question from e-mail and Tammy and this
question really gets at the impact on patients. Tammy would like to
know, what's the effect of drug shortages on patients?

>> There can be some very serious effects on patients. Patients may not
be able to get the drug of choice of their physician. There may be an
alternative treatment available but it may be one that is either not as
effective or that has more side effects. There's actually been a study
that was done on a shortage of chemotherapy drugs to treat pediatric
cancer patients and the children who were treated with a different
chemotherapy regimen than the preferable one actually had higher rates
of death so it can have some very serious outcomes. It can have negative
health effects and it can result in increased death.

>> Well given these serious outcomes we've got a good follow-up question
here from Rob over e-mail. Rob would like to know, how can individuals
find out what drugs are in shortage?

>> Well, I think we have a slide that we can put up. It's slide 4 that
shows the FDA website. FDA now maintains a list that is organized by
category of drug. You also can look for specific drugs by name to see
what drugs are in shortage and it has some information that can help
you. You also can talk to your physician or other health care provider
if you're having difficulty finding a drug that's been prescribed for
you. As I mentioned a lot of these are drugs that are administered in
hospitals so the hospital pharmacists are very engaged in locating
supplies of the drug. But as a patient you can go to FDA's website to
get additional information.

>> And a good follow-up, another one from Howard over e-mail, and Howard
would like to know, are certain types of drugs more likely to be in
shortage?

>> Well, the shortages have primarily been on generic sterile,
injectable drugs, the sterile injectable drugs in particular. And we
have a figure I think that we can put up that shows the distribution.
It's Figure 2 that would show that the types of drugs that have been in
shortage and as you'll see sterile injectable drugs are more than half
of the drugs that are in shortage and the bulk of those are these
generic drugs. There are some brand name drugs that are also in shortage
and some tablets or other kinds of drugs that have been in shortage. But
mostly we're talking about these sterile injectable drugs which are very
difficult to manufacture and have really high standards that you need to
meet.

>> And you just mentioned this issue of generic drugs versus brand name
drugs. Katy, over e-mail, would like to know, to what extent are drug
shortages an issue of brand name drugs versus generic drugs?

>> Well most of the shortages are of generic drugs and it's less an
issue for brand name drugs although there are brand name drugs that have
gone into shortage. Even with the generic drugs where there can be
multiple manufacturers, what we find is from the drugs that have gone
into shortage there typically are only one or two or maybe three
manufacturers. It's not as though you have half a dozen manufacturers of
a particular drug. Those aren't the drugs that wind up in shortage. It's
the ones where there are already only a few manufacturers working to
make these drugs.

>> All right, a good follow-up question here from Gregory over e-mail.
What's the cause of all these drug shortages?

>> Well.

>> Probably not an easy one to answer [laughter].

>> Well, it's not. It's not an easy one. We looked. We do have another
slide where we can show the reported causes of the shortages. It's
typically, and the immediate cause is some kind of a quality problem. A
manufacturer has some delay or some problem on their production line and
so those account for the bulk, I think. Quality problems and
manufacturing delays or capacity problems account for the bulk of these
shortages. The difficulty is sometimes it can take a long time to
resolve that quality problem and get a line back up and functioning and
because these drugs are complicated to manufacture, the injectable drugs
may have a long period. It's not something you can just make in one day
and so it's something that can't necessarily be resolved very quickly to
get that production line back up and running.

>> And before we go to our next question I just want to remind people
how they can continue to send us your questions and comments. You can
send them over e-mail it's AskGAOLive@gao.gov and thank you so much for
everybody who's been sending your questions over e-mail. You can also
send them in on Twitter using the #AskGAOLive so please do keep sending
in your questions and comments and we'll get you answers. So I'm going
to go to our next question that came in from e-mail from Samantha. And
you've mentioned in one of your answers about the impact on children.
This is another question that gets at that. Samantha would like to know,
how have drug shortages affected treatment for sick kids, you know,
given their special needs as patients?

>> It is a problem. We don't have a lot of information specific to
children. I mentioned the study of chemotherapy drugs that were in
shortage for children. Another big area has been the shortage of the
nutrition drugs, the parenteral nutrition for premature infants who need
to be fed by tube when they're still in the hospital and that's been a
very severe shortage. That's been difficult and FDA has been doing a lot
to try to resolve that shortage. And those are two that I know
specifically that have impacts on children. It's always difficult when
the drug is not available and physicians are having to make decisions
whether to delay a treatment or whether to try to use an alternative
drug. Children are more difficult to treat in any regard because there's
not as much information available about what drugs or in what dosage may
be most effective and so when you have a shortage the alternatives may
be less well understood if you have to treat a child.

>> And getting back to questions on the cause of this problem. Patrick,
over e-mail, asks, are quality problems manufacturers are experiencing
caused by insufficient investment in their facilities?

>> Well, there are certainly some folks who have looked at that and
raised that as a concern because some of the facilities that have had
some serious quality problems have been older facilities, and some of
the kind of problems that have been discovered on the lines are ones
that may be more common in an older facility. Again, as we said, we're
trying to understand more about the underlying economics and the extent
to which industry is investing routinely in modernizing their plants.
It's one of the concerns that's been raised. There also have been
concerns raised about whether or not FDA is expecting a change in
standards. The agency tells us no, that the standards are the same as
they have been but that, you know, as a plant is changing its equipment
if there's a problem they may only be able to get newer equipment that
might, you know, allow them to modernize but that can take time because
this is not typically off-the-shelf, an off-the-shelf item. It may take
some period of time to actually even get the new equipment that you
need.

>> Sure, so speaking of FDA, we have a question from Janet, over e-mail,
and Janet would like to know, why can't FDA import drugs that are in
shortage from other countries?

>> Well, FDA has done that to a limited extent. You know, FDA has to
approve the drugs that are distributed in the United States, and in the
few circumstances where they have gone to a manufacturer to see if
there's another company that makes that same drug for distribution in
other countries, if they have sufficient capacity and are willing to
make the drug and send it to the United States during the shortage
period, FDA still wants to assure that the facility meets FDA standards,
so they may go and inspect or they may see, you know, if, for example,
the European Union has just inspected that facility and if that facility
would have capacity to make the product for the U.S. market. They've
done that in only a few circumstances. It's one of the options that's
available. There's actually a recent court case that may complicate that
for FDA and so they're still trying to determine what their options are
moving forward.

>> And we did have a question about the court case that came in from
Chris over e-mail. Could you tell us a little bit more about that?

>> Well, there was a recent decision about FDA allowing states to import
limited quantities of a drug that was in shortage that's actually used
as part of lethal injections for execution of prisoners. And the court
ruled that FDA did not have authority to permit that kind of
importation. As I said FDA is still trying to decide what the
implications are for resolving shortages of other kinds of drugs where
there may not be domestic capacity available to fill the gap.

>> And in line with that, we got a question in from Dave, over e-mail,
and Dave wants to know, does FDA need more power or new authorities to
decrease the number of drug shortages or limit the length of time that a
shortage lasts?

>> It's not clear what different authorities FDA might need, I think
they have not yet made a determination if they need some clarification
of their authority to use this importation. FDA has not asked for new
authority. They have not indicated to us that there's any particular
legislative change that they think would help, and so it's not clear
that they don't have those tools with the possible exception of whether
or not they need some clarification on this limited importation.

>> Now, GAO did make recommendations in this report that came out on
Monday.

>> Yes.

>> So could you tell us what those recommendations were?

>> Well, we made recommendations to FDA to improve their database and to
conduct additional analyses using the data that they're developing. We
had some concerns that their database itself was not meeting what we
call internal control standards to ensure that the data that are being
entered are accurate and that they have policies in place for how they
are categorizing things and you know what sorts of information they're
putting into their system so that it's consistent. We also asked that
they consider doing some analyses to look at trends, not just to use the
data to record and monitor a daily status on an individual shortage but
to examine patterns across time, to develop some metrics to see patterns
if any exist so that as they develop data across a number of years
they're able to gain knowledge from it and not just use it on a daily
basis to track something. And FDA agreed with our recommendations and in
fact are already beginning to implement some of them.

>> Well it sounds like a lot of those recommendations could be really
useful in this situation.

>> Well we hope so, moving forward. We think that these are important
steps that, you know, any sort of database needs to have in place. It
needs to be used as a tool. It requires effort to develop this
information and you need to be using the information.

>> Absolutely. We have an interesting question here from Keshia over
e-mail and she would like to know, what's the status of drug shortages
of cancer drugs?

>> Well, cancer drugs were in severe shortage a couple of years ago when
we first reported in 2011. There are still a number of cancer drugs that
are in shortage but the number of drugs, cancer or chemotherapy drugs
that are in shortage has actually decreased. At one point they were
higher up on the list. They're now down I think to about fifth or sixth
place, and about 8 percent of the shortages are of chemotherapy drugs.
But there are still concerns about chemotherapy. It's so critical for
care of cancer patients and having the right drugs and having them
available quickly is important in providing adequate care to those
patients.

>> And an interesting question here from Scott over e-mail. Are there
incentives the government could provide to manufacturers to help address
the problem of drug shortages?

>> There have been some incentives that have been discussed. We actually
have a whole section in our report where we talk about a number of
different kinds of incentives. One example is a tax incentive, to
manufacturers for investment in their facilities to upgrade or to expand
their manufacturing capacity, to try to reduce the frequency of
shortages and the kinds of reasons that shortages are occurring. And I
think that's something that there's been some discussion on. There
hasn't been any specific action to put that in place, but when we talk
to manufacturers about that they told us that that might be useful for a
manufacturer that was already in the market, that was already making
these kinds of drugs. They didn't believe that that was going to be
something that would bring a new manufacturer into the market. And they
also pointed out that it would take a number of years to expand
capacity. They estimated about three years to expand capacity or upgrade
a facility completely so it's not something that would provide any kind
of a quick fix.

>> And next question here from Betty over e-mail. Betty would like to
know, I heard that some companies are charging huge markups for drugs
they got second-hand. Is this practice legal?

>> It's something that's called the gray market for drugs. It is legal.
There are concerns about the quality of the drugs that one might get
through this secondary distribution channel. Normally the gray market is
when it's not an authorized distributor of a drug, so the drug's been
distributed and then sold to someone else and maybe sold to someone else
before it's ultimately purchased for use with a patient. And the concern
is whether or not it's had proper storage and transport to ensure the
quality of the drug, that that's been maintained. Some of these drugs
require refrigeration, for example, and you want to be sure that that's
been continuous throughout the whole storage period. But there aren't,
it's not against the law to charge a higher price for the drug. Now, FDA
and the Department of Justice and the Federal Trade Commission are all
looking at this issue. We talked with those agencies and they are
communicating with one another and sharing information when they get
reports about possible gray market activities, the marketing of drugs at
exorbitant prices. It doesn't appear to violate any laws, however, and
if the shortage problem can be resolved then the possibility for selling
these drugs in this way, in this gray market, should be severely
reduced.

>> So we've got time for about one or two more questions left. I'm going
to turn to one from Gail that came in over e-mail and this is about the
role of pharmacies. Gail says, I heard that there are pharmacies that
mix drugs themselves. She thinks this might be called drug, I'm sorry,
called compounding pharmacies. Can they help out with drug shortages and
are the drugs these pharmacies making really safe?

>> Well, compounding pharmacies are something that's been in the news
recently. There was a serious meningitis outbreak associated with drugs
from compounding pharmacies, and so there was recent legislation
enacted. Actually just before Thanksgiving, the President signed the
Drug Quality and Security Act that clarifies FDA's authority over
compounding pharmacies and some of the larger compounding pharmacies are
now going to register with FDA as what's called an outsourcing facility,
and FDA will be inspecting them and trying to ensure that they're
meeting quality standards. Certain kinds of drugs may be amenable to
being compounded to fill the shortage. It's too soon to really know how
this new law and FDA's oversight of these compounders is going to help
fill the gap or if it's going to help fill the gap. I think it's just
too soon to say.

>> Well then, let me ask you while we still have time, what do you see
as the bottom line of this report?

>> Well, I think, our bottom line is that this is still a serious
problem. It has still been a growing problem. We see a very positive
turn in the number of new shortages that have occurred but it's not
something that's going to be quickly or easily resolved and that's why
we think it's worth our continuing to look at it, try to gain better
understanding of the underlying factors, and see if there are
opportunities for other changes to be made that would address these
shortages more quickly.

>> Well Marcia, thank you so much for taking the time to join us again
on another AskGAOLive chat.

>> Absolutely, my pleasure.

>> We really appreciate you coming here and talking with us today. And
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