[This Transcript is Unedited]




OCTOBER 12, 2006

Hubert H. Humphrey Building
Conference Room 705-A
200 Independence Avenue, S.W.
Washington , D.C.

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 160
Fairfax , Virginia 22030
(703) 352-0091


Subcommittee Members :

  • Jeffrey S. Blair, Co-Chairman
  • Harry Reynolds, Co-Chairman
  • Justine Carr, M.D.
  • Simon P. Cohn, M.D.
  • Stan M. Huff, M.D.
  • J. Michael Fitzmaurice, M.D.
  • Wanda Govan-Jenkins
  • Jorge Ferrer, M.D.
  • Karen Trudel
  • Randy Levine, M.D.
  • Stuart Nelson, M.D.


P R O C E E D I N G S [9:10 a.m.]

Agenda Item: Call to Order, Welcome and Introductions

MR. REYNOLDS: Good morning. This is a meeting of the Standards and Security Subcommittee of NCVHS. NCVHS is a statutory public advisory body on health information and policy for the secretary of health and human services. We are being recorded and are on the Internet. As we begin introductions, I will ask each of the members of the committee to note any possible conflicts of interest. We also will have a few of our members on the phone today, and I’ll have them introduce themselves also.

I am Harry Reynolds, Blue Cross and Blue Shield of North Carolina. Co-chair of the committee with Jeff Blair and I have no conflicts.


MR. BLAIR: I’m Jeff Blair, Director of Health Informatics Loveless Clinic
Foundation. I am co-chair of the Subcommittee on Standards and Security and I’m
not aware of any conflicts with the subjects we’re talking about.

Dr. Fitzmaurice: Michael Fitzmaurice, Agency for Health Care Research and
Quality, liaison to the National Committee and staff to the Standards and
Security Subcommittee.

DR. LEVINE: Randy Levine, Food and Drug Administration.

DR. NELSON: Stuart Nelson, National Library of Medicine.

MS. GOVAN-JENKINS: Wanda Govan-Jenkins, National Center for Health
Statistics, CDC, Staff to the standards and security subcommittee.

DR. COHN: Simon Cohn, chair of the NCVHS, associate executive director for
Health Information Policy for Kaiser Permanente, member of the subcommittee,
and no conflicts of interest.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services,
sitting in for Denise Buenning as chief staff to the subcommittee.

MR. REYNOLDS: Justine?

DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center member of the


DR. FERRER: Jorge Ferrer, Veterans Health Administration, staff to the

MR. REYNOLDS: Did any other members join on the phone?

DR. HUFF: This is Stan Huff. I just joined.

MR. REYNOLDS: If you’d introduce yourself please, Stan.

DR. HUFF: Stan Huff, with InterMountain Health Care at the University of
Utah in Salt Lake, and no conflicts unless we talk about HL7 and I may have to
recluse myself.

MR. REYNOLDS: Okay. We’re going around the room now.

(Introductions around the room.)

Agenda Item: NLM Testimony— Mapping of RxNorm and NDC

MR. REYNOLDS: Okay, our first agenda item is an

NLM testimony mapping of RxNorm and NDC, and Stuart you have the floor.

DR. NELSON: You have to forgive me, I’m a Mac person, I gotta figure out
how to run POWERPoint on this thing. How do I get to my slideshow? Ah, there it

MR. REYNOLDS: You should have been ready out of the box, Stuart.

DR. NELSON: Thank you. I wasn’t quite sure what you wanted to hear about
today, so I’m just going to try and give you a brief update of where we are
with RxNorm with a lot of special attention to what we’re doing with the NDC
codes. My presentation is pretty short. So, if there are questions at any time
please don’t hesitate to interrupt. I’m sure we’ll end up with lots of time and
perhaps even an early break.

Well, what I was going to talk about was the experiences that I know about
with Electronic Prescribing and RxNorm. Some problems that have come to my
intention about NDC codes, then I’m going to talk about NDC codes in RxNorm.
Our sources of them, how we represent them right now, what we’re going to be
planning to do in the future, and a few moments about outdated NDC codes. Just
try to think ahead about where we’re going to need to be going with our NDC
code portion of our work.

Well, there have been the pilots that were sponsored, I believe, by CMS on
Electronic Prescribing and at this point, we had not received any significant
feedback from the pilots. There were a few small requests for assistance in
understanding RxNorm, but I think RxNorm was fairly well documented, and people
understand it pretty well. I will observe that as somebody who practiced
medicine for a good number of years, that to me, the Electronic Prescribing and
the issues around it are much more concerned with dispensing than they are with
prescribing. That most of the dialogue relates to lots of things that have to
do with dispensing medications, and very little has to do with the way a doctor
actually writes a prescription. As a result of that, because of the focus on
dispensing and the relations of dispensing to billing and so forth, a lot of
the communications appears to be related or based on NDC codes.

Now there are problems with using NDC codes for prescriptions. First of
all, there is no doctor in the country who knows the NDC codes that well. There
are some drugs for which there might be as many as 250 NDC codes for a single
drug. It is very hard to maintain knowledge about drugs at the NDC Code level.
So if you want to do things like interaction checking or allergy checking, it
is very hard to maintain that at the NDC Code level. You just have to go
through and sort through it all. One of the things that you can’t do because of
the maintenance problem right now is to avoid the problem of overprescribing.
Ya know, how do you know the patient is taking Endoral and Propranolol? You
can’t recognize that from an NDC Code. And this, I think, is a significant
issue that needs to be addressed.

On the other hand, there are some real benefits in using NDC codes. Your
cost, your reimbursement, your inventory data are all based on your NDC codes.
And I think that there is a real value in doing that. There is a precision of
expression that’s allowed with NDC codes in that it allows you to specify a
particular product including the excipients involved, whether or not something
is– say for example, alcohol free, or lactose free, so forth, that you can not
necessarily represent well at the RxNorm level of expression. So there are some
real benefits in expressing things at an NDC level.

There are some other problems involved. Recently, I’ve seen some work done
on NDC codes that suggest that as many as 20% of NDC codes that are being
handled through a centralized clearing house involve locally generated NDC
codes. These could be repackaged drugs, drugs that have been compounded in the
pharmacy there, or (and this one was quite a surprise to me!) there are NDC
codes that are sometimes generated to cover the procedure involved in
administering the drug, which seems to be fairly far afield from the idea of
what you’re supposed to be doing with an NDC Code. But in fact, that is what
they are doing. There is some difficulty with representation of NDC codes,
whether it be a 10-digit identifier with 3 fields separated by dashes, or
whether it be 11-digit with no dashes or hyphens in it. You can go from a
10-digit to an 11-digit, but going from an 11-digit to the 10-digit, unless you
know where that extra 0 was inserted, you’re just guessing. So it’s only a
one-way conversion. You can’t convert back. I would put forth the idea that the
NDC code is not a meaningless identifier, although it is conjunction of three
meaningless identifiers. The very fact that its 3 meaningless identifiers
conjoined together has a certain semantics to it, and so it’s not quite a
meaningless identifier. The semantics that are presented are not helpful
semantics, particularly. Currently, there is no central authority for assigning
NDC codes. Now, I believe Randy is going to talk about a proposed rule where
the FDA is going to establish a central authority for establishing NDC codes,
and I think that that would be something to be commended and encouraged as much
as possible.

Another thing I was asked to talk about was: How ready is RxNorm to be used
for prescribing at a clinical level? Well, there are basically 3 different
types of elements of drugs or drug products that could be prescribed at a
clinical level. One of these are the drug delivery devices. These would be
things like a kit containing more than one drug, a prefilled syringe like an
EpiPen or of birth control pills where there’s three different types of pills
in the same package. We have around 1,800 of these in RxNorm right now. We do
not have a standard name, and we do not have them linked into what the
particular drugs are that are within them and what the particular ingredients
of those drugs are and strengths. This is something we’re currently working on
in our maintenance and system. And we expect to have that implemented early in
2007, that we will have those where they will also be linked also to the brand
and drugs and the generic drugs. Of the generic drugs, right now we have 17,600
generic drugs defined as ingredient, strength, and dose form as administered to
the patient, and we have about 14,000 drugs with brand names. I think that
these numbers have started to level off. In fact they actually dropped somewhat
which was encouraging because that meant we had found some previously
unrecognized synonymy where two things were being used as the name for the same

One of the encouraging things is that we have

been able to be cut by working with the pharmacy knowledge based vendors
and their vocabularies. We’re doing our best to support interoperation between
the users of the different vocabularies. One of the notable efforts right now
is that of the Cheddar(?). Which where the Department of Defense which uses
First Data Bank, I think because it’s primary pharmacy knowledge base is
communicating to the VA which has its own particular vocabulary. And we’re
working actively with them to facilitate that interoperation.

So where do we get our NDC codes that are in RxNorm right now? Well, as I
pointed out before, there is no single authority. No single source is
definitive. We’re getting it from three different sources right now. We have
the FDA NDC listing, that’s the NDC database. We have the VA National Drug
Formulary has NDC codes associated with it. And Multum of commercial vendors
has been providing us with NDC codes. The other commercial sources have not
chosen to share their NDC data with us. We would like to be able to at least
see that, because I’m going to suggest that this is an important way of testing
quality of looking to do quality assurance on that.

In the NDC listings, we have found various kinds of data anomalies that
we’ve been pointing out and the current listings of the NDCs are of much higher
quality then they were two years ago. We’re all aware of the recent inspector
general’s report about obsolete drugs stolen in the NDC listings. And that is
something of a concern, but I’m not quite sure how to go about approaching it
at this time.

Our original plan with the NDC codes was to have them linked as attributes
only to the generic drug. And we list them as attributes of these drugs at the
level of the source so that if Multum has a given drug and says it has an NDC
code, we will list those NDC codes associated with the drug as the source of it
being multum. So, we have 336,000 occurrences of NDC codes. Now there are
certainly a lot overlaps in that because the FDA listings and Multum listings
and the VA listings all intersect quite a bit. What we have found is that we
have about 20,000 conflicts. Out of that 20,000 conflicts; 12,000 were partly
as a result of our changing philosophy about linking the NDC codes to the
generic name and now some of them we are linking to the brand name. And as a
result of that change in philosophy we have about 12,000 them, we have the same
NDC code on a generic drug as on a brand name, which basically is the same
ingredients and same strength. The other 8,000 provide us with a really good
method of looking at quality control in RxNorm. Our editing, our model for how
to represent the drug, to see whether or not we have places where we did not
have clearly demarcated boundaries between how we’re going to name things.
Differences in dose forms and oral solution versus an oral suspension. One
source may have listed it has a solution and another as a suspension with the
same NDC code. So there are these kinds of issues that do arise. And some of
them are just frightened disagreement between the sources. And since we don’t
have an authoritative source, there is very little we can do about that except
to just say, “Well, we know there is a disagreement there.” and hope
it can be resolved.

Well, as some of you may know, last November the

FDA and the National Library of Medicine entered into, well it had signed
an agreement sometime before, but actually began the process of transmitting
the labels for medications in electronic format. The FDA would send them to us
in XML and that we put them on a web site and make them available for download
at a site called the DailyMed. One of the things that’s interesting about that
is that the NDC codes are listed in the label under the house applied section
in the label. And what we are looking is to use the DailyMed to replace the NDC
listings with the FDA as our primary source of information from the FDA. And
there are certain kinds of issues that arise for us in doing that. One of which
is that you can have more than one label for the same product. If it’s a
different package or whatever, they may have different labels but the same
product. So you can have the same NDC code in more than one label.

We have to learn how to recognize when a drug has

become obsolete or when a product has been withdrawn. If there is no label,
we can say everything in that particular label has become obsolete if there is
no label listing that drug. So, then we could then list this as being something
that’s obsolete. I haven’t really talked much about how we track obsolete names
of drugs and drugs in RxNorm. We have a fairly extensive process by which we
follow closely. That even though the most minor change in a drug name for one
of the sources results in our preserving the previous name as an obsolete name,
and then if there is something an RxNorm primary name, like what we would call
an SCD or an SBD, that’s the RxNorm name for that product if there are no
active names for that. Then we’d label that one as obsolete, but we’d still
maintain it in the system because if we want to do historical records on
various types of drug exposure issues or whatever. Then, you can at least know
what was that drug at that time and what was in it, which can be very
important. There are several child health epidemiology projects that are
currently using RxNorm as their method of coding the drug exposers that they’re
following over long periods of time. So, they need that historical information

What are we going to do in the future is we’re

going to take the RxNorm names, these names that we’ve created as the
meanings of doing the interoperation between the various sources, and we’re
going to assign to them an NDC code as an attribute. And, what we’re going to
have to do is the editors are going to have to use some judgment in the cases
of disagreement. I mean, there may be times when they have to say they can’t
decide, but we will have to look very carefully at each of those disagreements
and see which we believe is most likely to be correct. We are also going to put
into affect a procedure that I’m going to call cascading the listings. So for
example, suppose we have a drug delivery device. It carries a branded drug, and
this drug delivery device has an NDC code of 1. Then for the branded drug,
we’re going to say 1 represents also that branded drug in that sense, but 2 and
3 might be NDC codes; 2 and 3 might be just for that branded drug- various
package sizes. And then at the generic name, we might have other NDC codes, say
4, 5, 6, 7, 8, 9. And we will add onto that the 1, 2, and 3 NDC codes. In that
way, if you look to see if a drug has been administered– if a prescription has
been fulfilled by the particular NDC code. So, the pharmacy could dispense
something with an NDC of 1 or 1, 2, and 3 and still it would be recognized as
that prescription had been filled correctly. We’re still going to maintain the
source’s assertions about NDC codes even if, and noting full well that there
may be disagreements, so that one source may have an NDC code in one particular
area and the NDC atoms themselves will carry the NDC code in a different area
because we disagree with that source. But, it’ll be our own assertion that this
is where the NDC code truly belongs.

Well, another question is: What are we going to

do with the outdated NDC codes? What are we going to do when
something— that package size is not longer available or that drug is no
longer available. What are we going to do with that? And certainly with the
RxNorm NDC code attribute when the RxNorm drug is obsolete, we can still carry
those NDC code attributes. Beyond that, we do have some concerns about how to
represent NDC code assertions from a particular source. One of the things I’m
concerned about understanding a little bit better is: What the use case is for
having these obsolete NDC codes? Because, if we’re going to spend a lot of
effort trying to make sure that we track them appropriately, we want to make
sure the game was worth the candle. That it is significant. And that’s
something we’re looking at. And of course, we have serious concerns about
reusing codes. Practiced up until now and until the FDA takes control of the
process, the practice has been that once an NDC code has not been used for five
years, it may be reused. Now Joan Capusnik tells me that First Data Bank, which
employes an army of people calling pharmaceutical manufacturers to track their
NDC codes, notifies them if they start finding conflicts. I think that’s
absolutely fantastic, but we do need to get to a point where we can
automatically recognize and prevent the reuse of those codes, and that’s all I
really have to say about all of this. I’m open for any questions.

MR. REYNOLDS: Okay, thank you Stuart. Excellent.

What I’m going to do, since we have two members and one staff member on the
phone, I’m going to give you a first chance and a last chance. In other words,
I’ll let you ask your questions first and then I’ll come around to you at the
end also and it’s not your last chance to answer, but…

DR. COHN: I have a question.


DR. COHN: Is Randy also testifying or not?

MR. REYNOLDS: Yes, as a second testifier at 10:30.

DR. COHN: Oh, okay. I feel like half the questions I have for Stuart are
probably really for Randy.

MR. REYNOLDS: Well, should we have Randy go ahead and testify and then
we’ll ask all the questions?

DR. HUFF: I think it would be good to have Randy go because I think a lot
of the questions are, you know, are there things that we can do so that
everybody isn’t trying to do the same work so that we can actually come up with
an authoritative source for the NDC codes.

MR. REYNOLDS: Okay, so what we’ll do is, we’ll have Randy testify, then
we’ll take a break, then we’ll come back and ask questions.

Agenda Item: FDA testimony—Status of NDC

DR. LEVIN: I was going to cover the following topics. First, the proposed
changes to the FDA drug listing regulation that Stuart alluded to, and then
discuss issues related to distribution of the NDC information, and then talk
about the FDA medication information, identifiers, and terminologies that would
be useable for electronic prescribing and some future initiatives that we’re
working on with Structure Product Labeling and drug listing.

First, I just wanted to note that the work that

we’re doing is part of a broader collaboration that we’re working on, and
Stuart with the National Library of Medicine, but also with the Department of
Veteran’s Affairs and The Veterans Health Administration, the National Cancer
Institute, and Arc on this federal medication terminologies. We’re bringing to
this activity our Structured Product Labeling with a variety of terminologies.
And as Stuart was discussing, the source of new product information to our
Structure Product Labelling, and National Library of Medicine, bringing in
RxNorm in the clinical drug, and the process of linking this to the national
drug code as well as the distribution of the Structure Product Labelling
through DailyMed as Stuart was describing. The VA brings the National Drug File
Reference Terminology with terminology for pharmacological class like mechanism
of action, physiological effect, and structural class. And a problem with
subset of SNOMED they created with Kaiser and they’re linking RxNorm and the
NDC with the other National Drug File Reference Terminology. The National
Cancer Institute. The NCI thesaurus is a source for FDA terminology. We use the
NCI enterprise vocabulary services to maintain as a source for our terminology
and the source for a number of the terminologies we’re talking about are
available through the NCI Terminology Browser. And the Agency of Health Care
Quality and Research with the work of Mike Fitzmaurice have been helping me
with this project all along with various support and funding, so I just wanted
to note that.

In August of this year, we published in the federal register a proposed
rule to change the way we do drug listing. This rule has other aspects in it
other than drug listing, but I know we’ve been talking about this for quite
some time in this committee, and the proposed rule is finally proposed after
all these years. But a couple things that this does is that it proposes that
the FDA would manage the NDC, as Stuart was discussing, that we would be the
central authority for the NDC. Right now, the manufacturer assigns the numbers.
We provide a portion of the NDC, what’s called the labeller code, the first
part of the NDC, but the manufacturers then assign their own numbers. This
would move the assignment to the FDA from the manufacturers. It would also, in
this rule, lays out the specific rules. It clarifies the rules of what NDC
means and when does an NDC change. So what characteristic of a product, what
things have to change that would then lead to a change in the National Drug
Code. So, this is in this proposed rule. It also automates the drug
registration and drug listing process. It the moves it from what is now a
manual paper based process to an automated electronic process. And one of the
things we can do now that we have more experience with the Structure Product
Labelling is to merge the issues related to labelling with the drug listing.
And that’s what we’ve done in Structure Product Labelling. We’ve taken the
listing information. That’s always been existing in labeling, but we’ve now put
that in is as structure format in each label. And that’s the structure product
labeling that Stuart was describing that we distribute through with the
National library of Medicine through DailyMed. So, this is a very important
piece to merge these two activities together: Labeling and listing.

The other thing that the rule proposes is it

specifies which products can have a National Drug Code. Again, this is more
of clarification. There have been products that have National Drug Codes that
shouldn’t have National Drug Codes, and this lays out what products can have
National drug codes. The proposed rule takes into account a lot of the
information we have received here at this committee as well as from other
places so that we can better manage the National Drug Code, so we can meet some
of the needs that we’ve been discussing over here in this committee as well as
other places.

Now the rule was just proposed in August—end of

August. Then there will be comments to propose rule there. Other changes in
this rule that may be fairly controversial for different groups that may, not
necessarily related to things that are going on in this committee, but we’ll
have to handle these comments, and it depends on the number of comments
received, but they’ll be coming in over the next three or four months. Then,
once the comments are received and addressed, and then it goes through that
sign-off process that we all know about. Then, we can publish the final rule.
The rule proposes that the industry has nine months to update their listing.
After that time, the FDA takes over the listing, the management of the NDC. So
they have nine months to make sure that their products are on the list. So,
those are some of the changes that are being proposed. Again, this is a
proposed rule, so we have to get the comments and make changes. But again a lot
of the things that are in this rule are things that were discussed here and
other venues about what’s necessary for the management of the National Drug

Now because this proposed rule, what this would

lead, is that the FDA National Drug Code Directory would contain the
definitive list of valid codes. Right now that is not so. And as Stuart has
brought up, there are a number of problems with National drug code directory.
But because we would be assigning the codes, we would know all the codes. Right
now, that is not true, so that is one thing that would change with this
regulation. Another thing is that this Structure Product Labelling could be
then used as the method for electronically distributing this information at the
product level. So, it could be up-to-date information, as Stuart has noted that
this would be a place then that they could go to get the information, the
National Drug Code, at the product level. The Structure Product Labelling
contains not only these drug listing data elements, which I’ll go through in a
minute, but it also contains all the contents of the labelling and how to use
the drug and all the prescribing information and other information about the

Now, as far as the status on the structure

product labelling– by the end of this year, we expect to have the
Structure Product Labelling for the approved prescription on innovators. This
is not the generic manufacturers, but the least the innovators on the DailyMed
web site. Then, over the next few years, then we would be going into a
maintenance process. Again this is depending on the rule, when it goes into
affect. We have maintained the up-to-date Structure Product Labeling for
marketed drug products, both human and animal drug products, and maintain on
the DailyMed web site. So that would be the method for distributing the
National Drug Code information.

Now the drug listing information, that’s in the

Structure Product Labeling, describes the product, has the proprietary name
and a nonproprietary name (The generic name or the brand name, however you want
to describe that.), and the code or the product which is part of the National
Drug Code now. The National Drug Code of course has the three pieces. The
labeler talks about who the distributer is, the manufacturer distributed the
product, code talks more about the product, and then there’s a package
component. If you look at the first two components, you have a code that would
be specific for product. Now this again, because of the way that the
manufacturer assigns the codes, we can’t be assured that this is correct. But
with the way that the proposed rule has talked about management of the NDC,
this would happen: There would be a code specific to a product as defined in
the rule. So the rule will define what a product is and there would be a code
assigned to it and if anything changes in that product, a new code gets

We have in the drug listing information, also,

the ingredients, the active and inactive ingredients, and the active
moiety. Each of these has a name and a code. The code that we use for
ingredients is the unique ingredient identifier from the FDA Substance
Registration System. So, there we would have for each of the active ingredients
and the active moiety there will be codes. And I’ll go into more detail on this
in a little bit. There is also the active and inactive ingredients strength.
That would be that we use the codes that we’ve worked with with the National
Cancer Institute and the UCUM codes for strength. Dosage form is also in the
drug listing information. The appearance of the product is also in the drug
listing information, like anything that’s printed on the solid dosage form, the
color, shape, size, scoring, coding, symbols. Those are all part of the drug
listing information. Route of administration is part of the drug listing
information as well as the DEA schedule. And for packaging, it’s the package
type and the quantity and code for that. And the code for that would be, again,
the National Drug Code, which includes the packaging component. All these
things are defined in the proposed rule and then would be managed by the FDA.

This picture just summarizes identifiers. There’s

an active moiety, again the unique ingredient identifier from the FDA
Substance Registration System, this is part of the active ingredients. There
may be more than one active ingredient in a product. If you combine all the
active ingredients with the strength, the dosage form, the inactive
ingredients, and the appearance as well as the manufacturer, you get a drug
product, and you get a code associated with that. There can be more than one
drug product in a package combined, and Stuart mentions something along those
lines, and then the package type and quantity leads you to the packaged drug
product, which is what the National Drug Code is associated with. Again, all of
this, the rules would be defined in the regulations and managed by the FDA.

I’ll just go through some of the FDA medication

identifiers: the ingredients, the products, and the package products.
Ingredients: There is a substance that makes up the product. There is an active
moiety, which is the active ingredient without the counter ion. So, an example
of ingredient is oxycodone hydrochloride, the active moiety would be oxycodone.
And then, I just provide some ingredient identifiers. We have an identifier for
oxycodone hydrochloride. We have an identifier for oxycodone. There’s a
separate identifier for acetaminophen. We have identifiers also for foods. This
is part of our activity for the food allergy activity. So, you know, we have an
identifier for things like peanuts or milk as well as identifiers for
botanicals. So this year, we expect to have the identifiers for all the active
ingredients in the approved prescription drugs. We have identifiers for all the
food ingredients that came from the VA food allergy list and most of the
botanicals identifiers sends for some inactive ingredients. After the rule goes
into affect, we’ll be maintaining these identifiers for active ingredients for
other products such as over the counter products, biologics, and animal drug
products. And we’ll also, over time, be adding more inactive ingredients for
marketing products.

For the drug product, and again there is a

definition for the drug product now, it would be in the proposed rule. An
example of that would be Tylox. It’s the proprietary name for the product. A
nonproprietary name would be oxycodone hydrochloride, and Acetaminophen would
be the generic name. There is the product code that is associated with Tylox
and shows there is the product code. That’s defined by the characteristics of
that. Again, that’s in the proposed rule, what exactly is a drug product and
what would change. Right now, we have most of the prescription drugs in the
National Drug Code, and as Stuart noted, there are some problems with the
National Drug Code. And by the end of the year, we’re looking at the SPL with
the drug product codes for the approved prescription innovator drugs. Once the
rules goes into affect, then we will be able to maintain up-to-date Structure
Product Labeling with the drug product codes, would be in the Structure Product
Labeling for marketed products. Again, that’s with human and animal products.
So you have Tylox who is the example of a drug product. Now Tylox and 100
capsules in a bottle would be the packaged drug product, or Tylox 100 capsules
in a blister pack would be a packer’s product. Each one of those would have
their own National Drug Code. And that status of the packaged drug product is
the same as the status of the drug product.

We have medication terminology that we maintain. The manufactured dosage
form, the route of administration used to measure appearance and package type.
So, all these are available in the NCI Thesaurus. We’ve been using these codes
for quite some time in our drug listing process. The manufactured dosage form
examples would be a tablet, orally disintegrating; powder, for suspension;
injection, for solution. These each would have its own code and be available in
the NCI thesaurus.

The route of administration, examples like oral,

intramuscular, intrathecal, these are all in the NCI thesaurus and
currently available again being that we’ve been using those for a number of

Unit of measure: We use the Unified Code for

Units of Measure (UCUM) as well as some translations of units of measure
that we supply. So for example, a unit of measure might be milligrams per
tablet. The milligrams (mg) is the UCUM code. We have a code or translation for
that as just spelling it out as milligrams. But the per tablet that this unit
of oneness, this tablet, is not part of the UCUM codes that we provide the
codes for those, and that this would relate to so this is strength would also
the same thing used for product quality. So if you say there are 30 tablets in
a bottle, the tablet there is not the dosage form but this unit of measure for
how many milligrams in this unit. It could be milliliters per spray. There are
a variety of types of units of measure so that the code for spray comes from
the FDA that’s in the NCI thesaurus. All these are available in the NCI
thesaurus and UCUM is also available.

Appearance is for solid, oral, dosage forms.

These are the color, shape, size, coating, scoring, symbol, imprint code.
We have codes for colors and shapes. They’re not just text fields buts specific
codes. And the appearance would be used when we receive calls, or poison
control centers receive calls that they see they get this drug from the
pharmacist, and they want to know if it’s the drug they’re supposed to be
using. And they’ll give the appearance of it, and we would have the data in our
Structure Product Labeling so you could find out what that product is from the

Package type: Things like a bottle or a dialpack.

Those are again in the NCI thesaurus for any of the package types. Some
other initiatives, some potential future initiatives for the Structure Product
Labeling would be possibly adding additional data elements. One are the data
elements called Highlights Data Elements which I’ll go over in a minute, but
another activity would be adding something like the NCPDP billing Units. So
NCPDP has come up with a standard way for pharmacists to build for the
products. And we’ve been discussing with the NCPDP that that billing unit could
be added as one of the units in the structure product labeling, provided by the
manufacturers so that way it’s in the product labeling of how you would bill.
So their billing units are such as thirty each. Like Tow(?) would say 30 each
or something. However they describe their billing would be added into the
Structure Product Labeling as a way to transport this information from the
manufacturer to the prescriber. This billing unit is not really an FDA
activity, but it would be using the Structure Product Labeling as a way to
communicate between the manufacturer and the health care community with some of
this information. So, billing units is one example, but other information can
be put into the Structure Product Labeling as a way to communicate this kind of
information. Then would be available on DailyMed for download and use by
information suppliers whomever they would be.

We’ve also been looking at the Structure Product

Labeling for other products that the FDA regulates, for example medical
devices. There’s been a lot of discussion on medical devices and how to define
what a medical device is. The Unique Device Identifiers. We’re going to have a
public meeting on that soon. One of the concepts we’ve been talking about is
just as we have a drug listing component in the Structure Product Labeling, we
could have a device listing component as well and describe what a device is,
what components change in the device that would lead to a new code. So, this is
something that we’re working on.

Dietary supplements, Structure Product Labeling

could be used for dietary supplements for food products for other products
as well. One of the dietary supplements are one of the components that are not
drugs according to the FDA regulations, and they do not receive National Drug
Codes. Though some dietary supplements today have a National Drug Code
associated with them by the manufacturer. But this is one of the things that if
the FDA is managing those products, that this would not have a code. Whether
it’s important for them to also have a code from a central authority or
whatever, that’s something we would need to hear if that’s something that’s

I’m just going to finish up going over some of the Highlights Data
Elements. This is one of the new initiatives for the Structure Product Labeling
that we’re looking to add these codes. One of these is for indication,
including the intent of use. And the indication that this is a treatment for
migraine, or this is a prophylaxis for stroke. That would be coding that
information in for usage of the product, the maximum dose, so many milligrams
per day, that kind of coding. For condition of use is just an adjunct, like it
should be with aspirin. We would code that information in. If there are certain
screening tests that need to be performed, or a person should be monitored, we
would code those tests in like they should be monitoring the absolute
neutrophil count or something along those lines. Also, if there’s a condition
of use, it should only be used in a certain population, patient characteristic,
use in children under the age of six could be coded in. These are in the label
as a narrative text, but this would be data elements that are machine readable
following control terminology that would be coded into the system. Also, coding
in some limitations of use like contraindications or when you should use
something with caution or modify the dose where there’s little or no
information, or if it’s a second line treatment. There is some issue about the
duration of use, or that we approved it on a conditional basis. Those types of
information, like a drug is contraindicating women. We would code that kind of
information. Or the dose should be modified in patients with renal impairments.
Again, coding in that information. More interaction on Highlights Data Elements
would be interactions such as we would code a contributing factor and
consequence. Use with Dilantin has a consequence of increasing drug levels.
That kind of thing would be coded. Again, these are all using control
terminology in machine-readable codes. Use with MAO Inhibitors can cause
malignant hypertension. Coding adverse reactions could be coded as well as the
pharmacological class of the mechanism of action, physiological effect, and/or
structural class as codes.

A lot of the references for Structure Product

Labeling and the terminology are on the FDA data standards council web site
at www.fda.gov/oc/datacouncil
and you can see information about structure product labeling as well as other
standards that we’re working on at FDA. Thank you.

MR. REYNOLDS: Thank you, Randy. Nice job. What I will do is go in the order
of Justine, Stan, Jorge, and start making the list in the room. And then at the
end, I’ll come back around to catch you guys again so that you get equal
opportunity. So Justine do you have any questions?

DR. CARR: Yes, I do. Thanks. Both very interesting presentations. I wanted
to understand a little bit more about what we were just hearing about of the
coding into the label, the adverse reactions, or the interactions and
understanding how in terms of electronic prescribing, is the intent that that
code in the label would then alert providers about drug interaction? I guess,
perhaps, if I step back. I’m trying to understand where on the continuum of
drug prescribing this information would add value, and also would it be limited
to the information available at the time drug is approved, or is there some
mechanism for updating information as it becomes available after the drug is

DR. LEVIN: Well, I’ll talk about the procedure. The idea would be that this
would be conveyed information that’s in the label. So yes it would convey that
information. But as the labelling text changes, that this data elements would
also change, would be updated. So if there is a new adverse reaction and it
finds itself into the label, and then that could also then find its way into
the codes. So, the information is to convey information that’s in the label.
The thing that we’ve been trying to do is, with the Structure Product Labeling,
is get the information in a machine readable format and then make it available
in a standardized format like the Structure Product Labeling distributed
through the National Library of Medicine DailyMed site, and then let people
take that information and use it as they see how it could benefit. We weren’t
necessarily defining how it would be used, just that we would make it available
for use.

DR. CARR: Thanks.


DR. HUFF: So I know you said, Randy, in your testimony what the timeline
was for the proposed rule, but could you just repeat that? I didn’t catch that.

DR. LEVINE: The rule was proposed at the end of August. Then there is a
comment period, and it’s hard to know the length of the comment period because
people can request extensions for the comment because it’s a fairly extensive
rule. So the comment period may go for three or four months lets say. Then,
once the comments are received, the comments have to be addressed. Once they
are addressed, then they need to be agreed upon, not just inside the FDA but at
the department level, and then the office of management budget looks at the
final rule, and then the rule will go final. Once the rule goes final, and the
proposed rule, there is a period of time where the manufacturers would be
allowed to make sure that all their products are currently on the list of valid
products. So I think that right now, the proposal is, I think, a nine-month
period after the rule goes final. So they have that period of time. Once that
period of time finishes, then the FDA takes over the management of the National
Drug Code. That means, the reason for this is that every National Drug Code
currently in existence could be maintained, could be continued to be used.
Instead of doing just a broad change of all the National Drug Codes, but that
requires you to make sure the information is available to the FDA so that it
can be on the list, but once that period of time finishes, then if you want a
new NDC, you would need to go through the process to get the NDC through the

DR. HUFF: So it sounds like it might be easily a year and a half or two
years before you’re actually making assignments and covering that.

DR. LEVINE: I don’t know the exact timing, but you know how we’ve been
trying to work on this propose rule.

DR. HUFF: Right.

DR. LEVINE: Okay, so that gives you just a clue. If there are circumstances
that warn people moving things along quicker. I mean it’s just the way the
system works.

DR. HUFF: Sure. Well the comment I should have made first was just to
express my appreciation for all the work you’re doing. How you and the National
Library of Medicine, these are wonderful useful things that are really hard to
do. And I know they’re really hard to do, especially when you need to worry
about the proper timing and careful management of the regulation process, but
you know it’s really wonderful to see the development of these identifiers,
which are really going to establish a computable basis for medication use and
understanding of how we’re using them, what the interactions are. It’s really
wonderful work. Thank you for that. It’s unfortunate it takes so long, but I
realize it does. But we really appreciate what you’re doing.

My other question was for Stuart. As I understand, Stuart, right now the
NDC codes are listed as attributes associated with the generic or the RxNorm
clinical drug sorts of things. In our own electronic medical record data
dictionary, we originally had the NDC code as essentially synonyms or
alternative representations for generic drugs, and then after awhile we ran
into trouble down that path and said, ya know, we hate to do it but we’re
actually going to make these 300,000+ codes concepts because that’s what they
really represent. They represent something that’s essentially a drug product
associated with specific packaging and so there’s defining characteristics for
those things that allow them to be a concept and then we treated the rest of
the things as relationships to say that there’s a relationship between the
generic drug and this NDC level concept which I think a package product might
be the right name for what the NDC Code represents. And I wonder if you guys
have been thinking about that and what you see as pros and cons of making the
NDC Codes actual concepts in the Medi Thesaurus rather than as attributes on
the other concepts.

DR. NELSON: Thank you, Stan. Our primary difficulty in putting them in as
concepts in the Medi Thesaurus is always revolved around the problem of
tracking the meaning of those NDC codes and obtaining the meaning of the NDC
codes. It has indeed been somewhat problematic and remains somewhat problematic
which is why we’re very much welcoming the FDA’s proposed rule about
controlling the NDC Codes. I would wonder what additional value you would
obtain by making them concepts as opposed to keeping them as attributes of the
particular products. I’m not sure of the added value in doing that. I certainly
would be open to hearing more about that, but at one point we discussed whether
or not we were going to try and track NDC Codes as concepts in the Medi
Thesaurus and decided that it was not worth the effort to try and do that and
maintain the history of concepts that we try to maintain in the Medi Thesaurus
and so forth. Certainly have an open mind about the issue, but I would like to
know… Ya know, we don’t treat them as synonyms. We treat them as attributes.
We say that they are codes that represent specific entities that we are
representing at the RxNorm level. RxNorm level is a specific level of
abstraction about drugs. These are the things that fit within that category of
that abstraction. I think that that is all we can say right now with that. I’m
not sure. I guess the question back to you would be: What added value would I
get by making it a concept?

DR. HUFF: I need to think about it and make sure that it is worth it. What
you get is, you actually have a defined concept and there are more questions
you can answer than if you know that this NDC Code was given, and it does in
fact have a precise computable value that you can determine from the database
so that you know the manufacturer, you can imply in fact the exact drug product
that’s in there. Then there are more things that I know about how this thing
was given and prescribed than if its— but all of that value turns on exactly
what you said. And it’s probably premature to do anything now, but in the
future situation where we have well defined and controlled rules and processes
about when it’s created and the meaning of the NDC Code in terms of exactly how
it’s used and we’re not assigning them to things that shouldn’t have them, and
we’re not assigning them to devices, but taking care of all those issues. Then
I think there are things you can know about the prescribing process and about
he association of how often this packaged drug was given versus when that other
packaged drug was given in tracking of potential with the supposed
non-ingredients of the thing, etc. that would have value. But I need to think
about it and make sure that there is value there.

DR. NELSON: Alright, well I’ll look forward to hearing from you one way or
another. You know where to find me.

DR. HUFF: Okay. That’s all I had for now.

MR. REYNOLDS: Jorge, did you have anything?

DR. FERRER: I don’t have any questions.

MR. REYNOLDS: Okay, it would Simon and then Mike and then Wanda. And what
I’d like to make sure that we do, is looking up at the clock, we got about
twelve more minutes for Stuart, which I actually have one. But as we go through
this let’s make sure we honor his time and make sure we get our questions to
him. Because Randy was supposed to go to 11:30 so we’ll make him stay that long
and talk to us.

DR. COHN: Well I’ll ask a couple questions. I get a little confused about
who, and this is also tightly intertwined, as it should be, that it’s hard to
know who to look at with some of these questions. Let me just start with one
which is, I haven’t read the proposed rule. IS RxNorm is the actual code on the
box? Is it going to be printed there?


DR. COHN: Why not?

DR. NELSON: Well, I think that the RxNorm name and code, and by code here I
believe we’re talking about the concept identifier. Identify is a whole number
of different names for product, added given level of abstraction. Now a generic
drug might represent at that level of abstraction six or seven different things
that the FDA would call a product, meaning they have different manufacturers or
whatever. So, that at that level of abstraction, it’s quite different.

DR. COHN: I know all that. But it is the same medication, right?


DR. COHN: Or is it not the same medication?

DR. NELSON: Simon, this is the tricky part. It’s what makes it the same
medication. You know, when are two things identical? It’s a deep question. I
would put forth to you that every manufacturer would like to say that their
products are unique. To some degree that may be true. But we’re saying here,
under the generic drugs, because perhaps the excipients are different so that
it depends upon how you look at it whether or not they are identical. You can
say that they belong to a given category and that category as expressed by the
generic active ingredients and strength, they all belong to that category, but
they’re not necessarily identical.

DR. COHN: Okay. Let me explain the reason I’m asking. If anything, most of
us see RxNorm as being helpful in the actual prescribing of something that has
an NDC Code. At least that’s what I think most of us think that it has a place
there. And so I’ve heard from many people that it would be very valuable if we
were uninreusley(?) knew for an NDC Code easily what the RxNorm code was so you
could put it into a prescribing system and knowing that you were getting if not
one NDC, ya know, there’s always that issue…

DR. NELSON: Exactly.

DR. COHN: And the amoxicillins that you get, and they all have different
NDC Codes, and…

DR. NELSON: And that’s why we carry it with the RxNorm names so that you
know out of the 287 ampicillins 250 milligram tablets, they have 287 different
NDC Codes for that, that you know that every one of those NDC Codes fulfills
that particular prescription.

DR. COHN: Well, Okay, and so that’s in the database, it just isn’t on the

DR. NELSON: It’s in the way that RxNorm represents the NDC Codes as
attributes of that particular code. So we’ll say for ampicillin 250 milligram
oral tablet, these are the NDC Codes that fulfil that requirement at that level
of abstraction. And what I’m saying is, at that level of abstraction is a level
of abstraction, at least in my experience, is a level at which practitioners

DR. COHN: I think you’re doing everything but answering my question, but I
do appreciate… My question is should it be on the label or actually on the

DR. NELSON: I’m saying it’s not. Now I will tell you that at the DailyMed
site, after we get the product structure label we are going to associate that
product label with an RxNorm name. But understand that there might be six
different labels that are associated with the same RxNorm name.

DR. COHN: That’s my point. You got it. Thank you. That was my point. Now,
Randy, why isn’t it in the proposed rule and you serve a question. I mean, do
you have a thought on that?

DR. LEVINE: In the proposed rule is a requirement to put the NDC on the
package. That has not been a requirement up until now, but it is being
proposed. And then the NDC would be, when the label is being put together for a
new product, we won’t know what the RxNorm code is, because it hasn’t been
created necessarily yet. And so it’s only until we send it to the SPL to the
National Library of Medicine. Well, they assign at the RxNorm code. I mean,
Stuart, am I getting that right?

DR. NELSON: That’s correct. We don’t have access to the FDA’s proprietary
information before a drug is approved. Before a drug is approved, we would run
as approved the label is released. Then we get it, we can make an RxNorm name
for it. Until that, we don’t have access to that data. So it may be a process.
It may be something we can work out about having some kind of advanced notice
with an embargo or whatever. But until we have that data in advance, we can’t
give it an RxNorm name. Right? And an RxNorm identifier.

DR. COHN: So that actually even includes such things as changing bottles
from 30 to 25, making a new tablet green rather than yellow and all of that
which should get you new NDC Codes. That correct?

DR. LEVIN: When you make those changes, then you get a new NDC Code.

DR. COHN: And basically you’re bargoing(?) that from NOM until such time as
it is publically released with that new container and new bottle, even if it’s
Amocillin 250?

DR. LEVIN: Right. Once it’s made public, that’s when..

DR. COHN: And I apologize, I’m just trying to figure where all of this
fits. Exactly how valuable and useful, and once again as a patient’s safety
concern and other things, this issue of putting the RxNorm on the bottle would
be a very helpful thing or on the container. And so I was just, I guess I was
hoping that that would be there and that there would be obviously tighter
coordination between FDA and NLM in terms of all of this sort of happening
together as opposed to sequentially. So, it obviously speaks the fact 80% of
the way there, I’m obviously speaking about the state. Where we’re really
bringing patient’s safety first, I guess is sort of where I was trying to go.

DR. LEVINE: We proposed the rule, and there is a comment period.

DR. FITZMAURICE: Thank you. Now, one other question just to make sure I
understand how things are identified in all this stuff. I heard, obviously,
that NDC is being used in many interesting ways. And so my understanding is in
the future state. Yes, there will be a 100 pack of something or other, of
Amocillin or whatever and that will be in somebody’s pharmacy or, say, in a
hospital. And then they actually dispense it and give it to the patient. Well,
at that point it sort of transformed into an RxNorm dispense code because
there’s really no way to represent NDC at that particular level of annularity.
Is that correct? Is that how it sort of plays as we move here?

DR. NELSON: Well I would think that would be one way could play. Another
way could play would be that the NDCs do have three parts to the NDC code. And
the first two parts together constitute an identifier for the product, which
specifies the manufacturer. It doesn’t specify the package size, but it is for
a given product. That would be one way. I’m kind of interested, maybe could
sneak in a question to Randy, because this is very closely related. And that
is, Randy, you talk about NDC codes being in the SPL but you’re not going to
issue a new label every time they have a new package size, so what you’re
really talking about is having the drug product code in the SPL. Am I correct?

DR. LEVIN: No, every time there is a new package size you get a new label.

DR. NELSON: Really?


DR. NELSON: Oh boy, we’re going to be working.

DR. LEVIN: Because in the label is the how it’s supplied. So if a company
comes up with a new packaging, they can update their label with that
information. They definitely update their listing information with that. So
once they provide new listing information. So these are two components that
have in the past been separated labeling and listing. But if something changes
with the listing, that’s part of the structure product labeling now.

DR. FITZMAURICE: Randy had a nice listing of the partners that the FDA had
to do its portion of the Structure Product Labeling and shipping the
information over to NLM. Does NLM also have a list of partners?

DR. NELSON: Well, I would be remiss if I did not acknowledge the key role
that HRQ has played in the development of all of this. I would be very remised
not to because they certainly have been a very valuable partner. And clearly
we’ve tried to work closely with the FDA to make the DailyMed work and to
obtain that information and try to understand where we stand with things like
the FDA substance registry system and what those codes are and make sure that
we get those involved at the ingredient level and so forth. And working with
the VA and the Department of Defense as well to try to help them do what is
really a massive interoperation effort that the DOD and the VA is trying to do.
So I would have to acknowledge all of those folks as very close partners. I
think the NCI has helped a great deal with the terminology services for the FDA
that the NLN has not really been able to provide for them. I would like to
acknowledge that as well. You know, I don’t think any of it could have happened
without HRQ and their support.

DR. FITZMAURICE: Thank you, and I would say that support is an effort that
not only NLM and FDA put together, but also the office of the assistant
secretary for planning and evaluation. There’s been a coordinated effort to get
funding to this very important patient safety endeavor. And also, I would like
to respond that the Electronic Prescription Pilots didn’t come to NLM for
advice. If we haven’t, we should have. If congress should mandate additional
pilots or if issues should come up in the current pilots, we will be knocking
at your door. Semantics are an important part. I think many of them used NDC
Codes because that’s what was on the package and related to what the doctors
were prescribing. But it would have been a good pilot if we had more time and
more money to use RxNorm’s and link it with the drug information. Some of them
have tried to use RxNorm.

DR. NELSON: Yeah, I think it would be. Also, I’ll tell you frankly, the
last two years in RxNorm business have been a roller coaster because it seemed
to be an idea that took off before we actually had the wings on the plane.
We’ve been producing a new release of RxNorm monthly while implementation and
further refinements of the system that maintain the vocabulary are still going
forward. And so it’s been a wild ride. But I’m happy to say that we’ve had a
good team, and we think we have high quality information and I think we’ve got
a good product coming out. So, we’re working as fast as we can and as hard as
we can.

DR. FITZMAURICE: I want to follow up on what Simon said, because Simon
raised a really important issue. Is there anything that stands in the way of
NLM shipping of their information on a new drug or new package or new label to
NLM. How long does it take NLM to assign an RxNorm and then get it back to FDA?

DR. NELSON: What I am advocating and pushing my team to be able to do, is
to have it within a week. To at least have the preliminary identifier on it and
the attributes and that means we’ve received it, we’ve processed it, and a
human has sat down and looked at it and said, “Yes, it fulfills our
rules.” We have very strict business rules about how assign strengths for
medication, fordoes forms, and so forth, and a human has to really look and
make sure that all of those things have been done correctly. So, I would say
that my goal is within a week of having to receive the information from the
FDA, we will turn around and have it ready.

DR. FITZMAURICE: And the preliminary fractions needn’t add a week to the
process. It could be done sometime before FDA issues the…

DR. NELSON: If we did, I understand the FDA would have concerns, and I
would have concerns as well about making sure that we don’t release proprietary
information before its release date. I work at a library. We make information
available to people. We’re not in the business of hiding information. So it
kind of takes a little bit of a different mindset about how to do it. I think
it would be possible to do that if it were only internal in our system to do
that. That’s probably something Randy and I need to… Randy had lunch a few
years ago at an HL-7 meeting. And Randy said, “Would you guys be
interested in having labels?” and I practically fell out of my seat. Maybe
Randy and I need to have another lunch where we could talk about futures.

DR. FITZMAURICE: Stuart, slide number 6, you talk about other problems with
other NDC codes and you say there is no semantic link. Do you mean that a drug
might have different names and that there is no semantic link to the other
names? I’m not quite sure what that meant.

DR. NELSON: There is no way of knowing short of something like RxNorm or
another source that you could find out what NDC codes are for the same types of

DR. FITZMAURICE: So there’s no good classification?

DR. NELSON: It’s not a classification. It’s an assignment of an identifier.
Yeah. For better or for worse, I think that the NDCs were developed a long time
ago, and I think at the time it was very farsighted for them to do so. I think
now the time has come to look at it and say, “Yes, we to get the horse
back in the barn.” Let the FDA control those NDC Codes. Let’s make it a
little bit easier for people to have access to the information of what is
involved with them.

DR. FITZMAURICE: My last question is: Is the same information in both NLM’s
UMLS Medi Thesaurus and NCI’s Medi Thesaurus? I know that there is a lot of
mapping of RxNorm to NLM’s Medi Thesaurus and that a lot of the semantics and
the units come from NCI’s Medi Thesaurus. Is there good partnership? Is there a
reason this should all be in one place, or can things be electronically so it
doesn’t hinder anybody?

DR. NELSON: Well, I think the NCI has had a somewhat different model with
what they want to do with their terminology services. For example, what they’ve
done with the subsets for the FDA terminology, they’ve done with lots of other
kinds of terminologies specifically related to cancer. It all gets incorporated
into the ULMS on a periodic basis. I think it would be better for us at RxNorm
to be able to have direct access to those FDA medication terminologies subsets,
rather than try to go through the NCI Thesaurus because then you have to wade
through a whole lot of material to extract a small amount.

DR. FITZMAURICE: That raises a business use question. Are both available
for private sector production work or available just for research? Is it
something of like a first data bank, a multum could access these files and use
them to add information to their products?

DR. NELSON: Well, the ULMS has a fairly extensive licensing procedure
because we have proprietary naming products in the ULMS as well as things that
are public domain. Now, for example, in RxNorm, is first data bank is
proprietary. If you’re going to use their terminology and their codes, you need
to have a license from first data bank. On the other hand, the RxNorm names and
codes are right there right next to it, and they are not proprietary. Okay? So
that if I don’t have a license to use First Data Bank, I can still use the
RxNorm portion of it.

DR. FITZMAURICE: Can you speak to the National Cancer Institute or is that
for somebody else…

DR. NELSON: I think that the National Cancer Institute would have to tell
you what vocabularies they have that are proprietary are and non-proprietary.
And of course, all of us, we have a National license for SNOMED, so anyone in
the United States can use SNOMED which is proprietary but essentially a
national license so they can use it.

MR. REYNOLDS: It’s past your time, can you take a couple more, or are you
out of here?

DR. NELSON: Sure, we’ll just keep our fingers crossed that my meter doesn’t
run out.

MR. REYNOLDS: Okay. Did you have one for Stuart?

MS. GOVAN-JENKINS: This is my question: Prior to FDA, how and who were the
NDC codes generated in? I’m just kind of concerned about duplication. Maybe I
don’t know the history behind it, but duplication of NDC Codes as far as
quantity control?

DR. LEVIN: The NDC codes were, the system was set up many, many years ago
and the way that it works is that the FDA provides, it’s the three codes, three
parts. The first part is what’s called the labeler. And the FDA assigns that to
manufacturers and it will repeat. We only ever assign that once. I’ll give you
a labeler code then you go off and assign the rest of the NDC for your
products. So you’re going to come up with a new product, you’re going to give
it a new code using that labeler code. That prevents duplication because you
own that domain of NDCs so that you can assign that. Now, that said, once you
take the hyphens out, and you just have a string of numbers, there can be
duplication because the way that the National Drug Company works is the pattern
of the ten digits can change as there are only three acceptable patterns and
they can be duplicated if you remove the hyphens. There is that potential.
Usually because this would cause problems in the market, you would probably
find that out pretty soon that if you duplicate it. We look through our codes.
We found one duplication. Theoretically it could be a problem. But you own that
labeler code, and that way that helps you prevent from duplication. With the
FDA managing it, then there are stricter rules, including that we wouldn’t have
any duplications.

MR. REYNOLDS: Okay, I got one and then Karen, and then we’ll see if we can
get back to ya. And mine’s just a point. You don’t look at your two
presentations because Randy on the package drug product, you list a number
that’s 12 including dashes, and you were talking about 10 and 11.

DR. REYNOLDS: Without hyphens. You can take a ten-digit, hyphenated, and
basically of the three acceptable patterns by padding with a zero you can
essentially make a unique eleven-digit identifier out of the ten digits.

MR. REYNOLDS: No, I understand. But if you look at…

DR. REYNOLDS: It’s twelve digits if you include the hyphens, but you know,
so if I say it’s a twelve-digit versus an eleven-digit without hyphens. If I
put in a zero in the right place, then I can pad it. I can make it a unique
number. And the fact is that various sources, various pharmacy knowledge base
vendors, may or may not do that and may or may not indicate where they padded
that extra zero. Okay?

MR. REYNOLDS: Okay. No, that’s fine. I heard ten and eleven, and I saw
twelve and I just wanted to at least make sure…

DR. LEVIN: The NDC is ten-digit. The dashes are not. We don’t include those
as a digit in the NDC. Because in the barcode, you don’t represent those dashes
as a series, and that where is you can potentially have duplications because
some of the times the labeler code is four digits, sometimes the labeler code
is five digits. Sometimes the product code is three digits; sometimes it’s four
digits. So there are three different patterns. And if you remove those dashes,
you don’t know which pattern, just by looking at it, you don’t know which
pattern it is.


MS. TRUDEL: Yeah, Stuart, a quick question. You said in your presentation
that currently one of the issues is that no one source is authoritative.

DR. NELSON: No one source for the…?

MS. TRUDEL: For the NDC.

DR. NELSON: …for the NDC is authoritative? Yes.

MS. TRUDEL: So the rest of my question is then after Randy’s final rule
goes into affect and nine months later, then the FDA takes over the maintenance
of the NDCs. Does that become the one authoritative source for National Drug

DR. NELSON: I sure would hope so.


DR. NELSON: And I’m looking forward to that day.

MR. REYNOLDS: Okay we have a question from the audience if you could push
the button on that and introduce yourself and either make your comment or ask
your question please.

MS. CAPUZNIC: Hi, yes, my name is Joan Capuznic. Stuart referred to me in
his comment previously. We so submit our information on a regular bases to the
NLM. And again, that facilitates the creation of the RxNorm concepts. Both
happen after the fact after the NDCs released from the FDA, and there is a huge
timing issue. There is also the research that has to occur to say, “Is
this a unique concept or not?” And NDC that’s released by a manufacturer
and they hope for uniqueness in the marketplace, of course. We have to decide:
Is this really a dose form that we already know about, is it a strength that’s
reasonably new? They might change something by a half a milligram to be unique.
So there are a lot of issues regarding that RxNorm concept identification. So
there’s a lot of research and work that goes into that.

Also, as far as the NDC is a lot of information has flowed about the
patterns of use in certain business requirements, in certain forms that are
filled out, there is a specified number of byte spaces that need to be used, so
that the filling zero is actually important for certain business purposes, and
it would be great to have rules around collapsing and assigning those things so
that we know that if a zero has been filled out for one purpose, that you can
actually collapse back and find out what NDC was actually prescribed in another
system that there is synonymy known there.

MR. REYNOLDS: Okay, any other last questions for Stuart so we don’t his car
towed? Stuart, thank you.

DR. NELSON: Thank you.

MR. REYNOLDS: I really appreciate you coming and joining us. What I’d like
to do is, let’s take a break until 11:10, and we’ll be back. And then Randy, we
can continue with the questions for you. Thank you.


MR. REYNOLDS: Justine and Stan and Jorge are you back on? Okay, everybody
back on the phone? Justine?

DR. CARR: Yes, I’m back. I’m going to have to get on off five minutes.


DR. HUFF: Yes, I’m back.



MR. REYNOLDS: Okay, good. Alright, we’ll continue our questioning of Randy.
So let’s go back through it again. Justine, do you have anything else for

DR. CARR: Not at this time, thanks.




DR. FERRER: Not at this moment.

MR. REYNOLDS: Okay, Jeffry?

MR. BLAIR: Not right now.


MS. TRUDEL: I do have one question. What I have heard from a variety of
sources is that the NDC directory currently does have obsolete NDCs in it, but
there may be NDCs that are not there at all, that actually belong to real live
products that are on the market. Of course, they’re not linked up to RxNorm.
So, my question is then: at what point in time will we have a freely available,
noncommercial directory that will have the complete up-to-date list of codes
and that those codes will be associated with the appropriate RxNorm codes. And
I think that what you’re saying is you need final rule, plus the nine months to
take over the database, plus the period of time (like 2007-2010) to link it up
to the structured product label, and at that point we would have a complete
authoritative database of NDCs that are associated with the proper RxNorm
concepts. Is that right?

DR. LEVIN: Those are only estimates, but everything but the last piece, the
hookup to the RxNorm. That is when we send it to the National Library of
Medicine. But you’re right, the process would require us to be able to move
this information from our listing to SPL and then they would be able to provide
the link to the RxNorm.

MS. TRUDEL: Okay, and then I’m just looking at the time table here:
2007-2010 would be needed to completely get all of the drug products into the
SPL. So that they would all be there in that place. 2010 about?

DR. LEVIN: It’s as much as I can guess based on what has to happen with the
rule and it will take time to get that, but it will be something that can
happen if the rule goes into affect.

MS. TRUDEL: Right. Great, thanks.


MR. BLAIR: Randy, the presentation you gave was very very helpful and I
realize there’s things in the Structure Product Label that I was not aware of
before. You mentioned that some of the elements that are in there, even coded
elements, include the ingredients for a drug and to what degree are the
codified ingredients overlapping or redundant with RxNorm codes?

DR. LEVIN: Well, the way I understand it is that the National library of
medicine, they take the information that would be in a Structure Product
Labeling which would be the ingredients and then use those to create the RxNorm
code, like a clinical drug code, but they would create that based on what they
see in the labeling, but they do something in addition because one of the
things they have is the clinical drug is based on the order-able dosage form
and what we have is the manufacturer’s dosage form. So we will say it’s a
powder for suspension. That’s how we would classify the dosage form. But they,
I think, would say is a suspension. So that’s a difference. But I think they
could use the information that’s in the structure product labeling to use that
to create the RxNorm.

MR. BLAIR: Well, then let me ask the question a little differently. I
thought the purpose for why RxNorm was being created was to give the clinical
drug ingredient codes defined in such a way that it would be helpful especially
any prescribing for drug-to-drug interactions, drug lab, drug allergy, all the
rest with some clinical specificity. If FDA is now providing that in the
Structure Product Label, why do we need RxNorm codes?

DR. LEVIN: In the Structure Product Label, we don’t have the elective code
for the grouping of all the ingredients, the dosage form and the strength, we
don’t provide a code for all that group of entities. Though, if it was
automated, we could provide that, but we have not been and that’s not one of
the things that’s been given to us as like it’s a need or that’s what we should
be doing. So what we’ve done is, we’ve created the codes per the ingredients,
the dosage form, the route of administration, and then handed that over to
National library of Medicine that create RxNorm code.

MR. BLAIR: Okay.

DR. LEVIN: I’m not giving you a good answer, I guess?

MR. BLAIR: Well, it almost sounded like what you’re saying is that you are
getting pretty close to providing information that might be sufficient for
e-prescribing vendors to just take the Structure Product Label and do the
drug-to-drug, drug-to-allergy or is this something that I don’t understand? Can
they do it? Would they be able to do it just as well off of the information in
the structure product label?

DR. LEVIN: Well, in the Structure Product Label would have the ingredient.
It would have mapped to the National Drug Code. So both of those are in the
Structure Product Labeling. If the information vendor wanted to get that
information, they could get it right from those two pieces if that’s what
they’re using to, say, “If you’re allergic to this ingredient, don’t take
these products.” That information would be in the Structure Product
Labeling because the ingredient is in the Structure Product Labeling. So you
would know every drug that has that ingredient in it.

MR. BLAIR: It sounds like you’re saying yes. So maybe I’ll do the corollary
question. What is it that the RxNorm code provides that would not be available
directly from the Structure Product Label?

DR. LEVIN: It provides a single code for this clinical drug. That is not in
the Structure Product Labeling at this time. There is no code that says,
“For oxycodone and ampicillin” together that are these strengths that
are a solution or something like that. There is not a single code in Structure
Product Labeling at this time to do that.

MR. BLAIR: Okay, thank you.

MR. REYNOLDS: I had a question on your slide that was potential future
initiatives and you made a statement. It was under other drug product data
elements, and you talked about NCPDP billing units. And you made the statement
that that would be information sent to the prescriber. I would have thought
that would have been information sent to the dispenser. So I’ll show my lack of

DR. LEVIN: No that was my misspeaking. What I was trying to say was this
would be a, this communication from the FDA but from the manufacturer we would
be passing this information along to the health information system, whoever
needs that kind of billing information. Like you said, it would be the

MR. REYNOLDS: I’m just trying to keep up with it, and it just struck me as
we listened.

DR. LEVIN: And I just thought that that was a good example of something. If
you step a little bit further away just from, and this is from the FDA
perspective, this is my own opinion, not that that’s necessarily FDA’s issue,
but it’s here the Structure Product Labeling is a way that to communicate this
kind of between two groups that are using this product and the Structure
Product Label could help in that.

MR. REYNOLDS: Oh, good point. It was my edification. Any other questions in
the room?

MR. BLAIR: I’ve been thinking of more as we go along.

MR. REYNOLDS: We’ll wait a couple more times until Jeff sits back. He
figures it out and then sits back.

MR. BLAIR: I think that we’re all aware of the fact that there’s an issue
that hasn’t been resolved with respect to controlled substances being included
in prescribing in terms of security requirements for that. So, when I ask this
question, I’m not getting at that. I’m not asking about whether they could be
used to me prescribing or not, or the security arrangements. But what I’d like
to ask is, with the Structure Product Labeling are those also for products that
are controlled substances?

DR. LEVIN: Yes, they are. You mean under the DEA control?


DR. LEVIN: All marketed drug products is under this idea of the drug
listing. And in one of the data elements actually that we capture is the
schedule. If they’re under a schedule in DEA, we capture that
information—which schedule. And that’s one of the data elements that’s in
the Structure Product Labeling so you can see which schedule the drug is under.

MR. BLAIR: Thanks.

MR. REYNOLDS: Okay, anything else? Stan did you have anything else?

DR. HUFF: No, I don’t.

MR. REYNOLDS: But I would echo Stan’s comments earlier. This has been
exciting to watch this happen. You guys have done a lot of work to get this to
the point that you’re going to issue a regulation. We had a sidebar during the
break that it might be helpful since this rule is coming out, and we got our
meeting at the end of December, and that kind of ends the comment period that
hearing the positives that Stan had to say and all of have seen through this
work would be to at least put something together in short letter to the
secretary commending this effort and recommending that it continue and be
supported and that it appears from the things we’ve heard over a long period of
time that it’s a real positive step that’s going to make a difference.

DR. LEVIN: I’d also like to thank the committee providing a lot of vision
and support for this kind of activity. It’s been very helpful for us to move
forward, so I want to thank the committee for that help.

MR. REYNOLDS: Okay. Any other comments? Randy, thank you very much. Thanks
for being willing to be flexible, to make your presentation early so we could
kind of coordinate both of them. Thanks.

Agenda Item: Subcommittee Discussion

Okay what we’re going to break into next is some subcommittee discussion. I
kind of started off with some of the things that we have coming up, and we’ve
been trying to work this last night, this morning, at break trying to figure
out we’ve got a lot going on and how to make it happen. Let me go through a
list of what it appears that our inventory is. Right now, what we need to do
and just how we appear to have it assigned.

The CHI letter that we’re going to produce is being coordinated by

Margery and Stan. So they will be getting us out a draft on that to have
something ready for the full committee in November. We have discussed out of
yesterday’s testimony by WEDI and so on. We have discussed a letter that we
could put together for the November full committee relating to what we’ve heard
so far and alerting the secretary as to the current status, as to the current
discussion about transition periods. And that is something that we will monitor
in our next hearing. But that is something that probably needs attention right
now to make sure that it is on the radar screen and to make sure that it does
get the appropriate attention from the department and others as to how it’s
going to play itself out. Jeff, is that a fair stipulation of what we said?

MR. BLAIR: Yeah.

MR. REYNOLDS: Okay. The third, obviously, is going to be a Hippo Report
that will be out to us soon. Sorry, back to the NPI letter. Karen and I will
coordinate the preparation of that draft letter for the committee. The Hippo
Report will need the involvement of everyone. Because obviously it’s based on
the hearings and the information that we heard over a substantial period of
time and what we’ve seen happen, so we will want to be editing that… Jim
Scanlon, his group. So Jim’s got that. It’s just that we will then have to
group up once we get a draft of this out and approach it accordingly. The NHIN,
yes this is not the NHIN committee, but it really constitutes most of the NHIN
committee. So Simon, Jeff, and myself are coordinating that effort and letter
that’s being produced there. So that’s one of our collateral that we’re dealing
with. You just heard me make the comment on the NDC rule, and I hate that Randy
just walked out, because what I was hoping was that, I know that FDA can not
comment on FDA’s letter, but a little bit like Margery, I would like if Randy
could help take the lead maybe with Karen, you, or Denise to put together a
draft letter for us to send to the secretary on this rule that’s out on the NDC
codes so that we could at least, again, commend the effort, commend the fact
that it looks like from discussions we’ve heard and what we saw and what we’ve
kind of driven over time.

MR. BLAIR: I think what we’re saying is that it’s the letter relating to
the NPRM for the structure product…

MR. REYNOLDS: That is correct. That is correct. Thank you for that
stipulation. Randy, we assigned you something to help us with while you were
out which is we would like you, if you would, to work with Karen’s office to
help us draft. We know it’s not coming from you as a member of FDA. It is you
as support to our committee helping us put together a letter that we can get to
the secretary from the committee. Now once you help with the draft, so that we
can keep you in the appropriate position, then we would have you kind of
extract yourself from it so that that way you would not have a conflict of
interest as we adjudicated the letter. You think that’s a good way to handle
it? Appropriate use of staff, but we will not keep you in the forefront of it.
We’ll take it over. Okay? In other words, you would help us as one of our staff
members, but we’ll take it over and be responsible for it and would not be you
as the author, so you wouldn’t have to worry about that. So that way, I think
that would be helpful. Because you’ve sat through all the testimony with us
through this whole thing end to end, and you are our subject matter expert in
that, and so I think that would be very helpful rather than us kind of slosh
through something that turns out in the end not really depict in the subject as
it should be. And again, we can overwrite that draft it’s not what we had hoped
for. So if you would be willing to help us with that, that would be good. And
we would want to have that ready for the November hearing with the full
committee. So again, we got a lot of collateral we got to get done, again,
which this committee seems to be our life as far as this is concerned. Michael?

DR. FITZMAURICE: But would it make sense to, in that letter, to ask the
secretary to consider putting both the NDC code and the RxNorm code on a
package, given that there is a regulation coming up? Have him look into that
since RxNorm links to a lot of drug information that might not otherwise be
available to a purchaser?

MR. REYNOLDS: What I would recommend is that you’re passing that on to
Randy and Karen as the drafters to put it in there. Again, we’re drafting a
letter and then we’re all going to look at it and decide how far we do or don’t
want to go. I mean, everyone of these issues we have, ya know, once we see a
draft, we’re all going to have opinions. And then we play it in some kind of
open forums, there will be people with opinions. I don’t have any concern about
adding anything to it right now. If that’s a reasonable… and then
obviously, it will be decided by the committee whether or not…

DR. FITZMAURICE: Yeah, that’s what I’m asking. Okay.

MR. REYNOLDS: I think that’s a good way to do it, don’t you?

MR. BLAIR: Yeah, I think with Karen drafting the letter, and Randy
providing advice, that’s a good way of handling it.

MR. REYNOLDS: So Michael, we will ask them to take that into consideration
if you would send them any wording you would think would be appropriate about
that, that would be great.

DR. FITZMAURICE: Also, do we want to complement FDA, NLM, and NCI for their
moving forward drug vocabulary and encourage the free exchange of information
among those three to improve patient safety through drugs. I didn’t sense that
there was any problem, and I think Stuart said that NCI stuff is in the Medi
Thesaurus, but it recognizes the cooperation and encourages any additional
cooperation that might be needed.

MR. REYNOLDS: Any issue from anybody else? Randy, you good with that? No
comment? Alright, good. Okay.

Anything else on that particular subject before I move forward?

Okay, we’ve obviously got to produce a number of things before November. We
also have to start planning ’07. And we, ya know, kind of really had to be
focused on some key initiatives in ’06. And so we’ve gotten away from our kind
of our idea of a balanced portfolio where we look into the future. We look into
the near future, and then we kind of maintain the current. And so what I would
like to recommend is, I would assume that in the November committee meeting, we
have a break-out time. That we use that break-out time… I’ll send out
ahead of time the chart that we’ve been using on what our portfolio needs to be
and the items that we need to think about. Send that out ahead of time and then
use our break out time out on the full committee meeting to adjudicate what we
would want to make our ’07 look like. Does that make sense? Jeff, you good with
that? Everybody okay with that? Because I think that’s the next, trying to do
that now is not going to be productive because we don’t have it out.

DR. HUFF: Yeah, that’s fine with me.

MR. REYNOLDS: You good with that, Stan? Thanks, okay. Yeah, let’s do that
so we can really get a good look at ’07. And at that point, please bring your
calenders because then we’ll start trying to set our meeting dates for ’07 and
we’ll be in good shape as far everybody having their dates with them, and we’ll
make sure we get what we need done.

Okay, let’s talk about December. We had a December hearing. We have
discussed it some yesterday, some last night, some this morning, and some a few
minutes ago. With the fact that we’re sending an NPI letter now, and then we
would want to closer to the date probably weigh in again. We also would want to
be able to hear a little more about the e-prescribing because it would have
passed the end of the year, and maybe people can talk to us. That we would have
some kind of a January hearing. Marietta, if you would start pulling people as
soon as you can to look at a January hearing where we would definitely probably
want to hear more of a diverse testimony on NPI then just WEDI, and to make
sure the record’s clear, WEDI has done an excellent job of grouping up. But one
of our strengths is to make sure that even though some people are grouped up,
we hear from everyone, and we give a complete and balanced look at that.
Because again, we have a February full committee, so then we would be able to
put another letter out in February that could really start discussing exactly
what May is going to look like and whether or not this extension should have
anything wrapped around it that we would want to recommend if there were such a
transition period. Comments on that?

MR. BLAIR: If we’re going to have a meeting in January together, more
information on readiness for the NPI where we would be making a recommendation
in February. Does it add a lot of value for us to have a letter in late

MR. REYNOLDS: Well, the discussions that have gone on is that since we have
not said anything, but we’ve had a couple sets of testimony. And for example,
WEDI’s initial letter went to the secretary. We have now heard twice from WEDI,
and I think we would be remiss. I mean, the discussions have been, I think
Karen agrees, we would be remiss at not making sure that the secretary is aware
that this is not just an easy walk to May. So from us, as the advisory. If you
look at the results of the surveys that were presented, the industry is quite a
ways of from being able to actually fully meet a May date. So, I’m not sure if
that makes the answer any better.

MR. BLAIR: Maybe my only question was: If we’re going to send a letter on
this issue in February, why are we sending another one the last week in
November or like December, ya know two months before.

MR. REYNOLDS: Because it’s six months from implementation. At that point,
it’ll be two to three, which means… In other words, right now we’re
talking about May, and a little bit past that. In February, we’re going to be
talking about what does it really look like end game is?

MR. BLAIR: Okay.

MR. REYNOLDS: That’s the thought. Now again, what is important in each of
these? Let’s do the draft letters. Remember, this committee has had letters
withdrawn. We have withdrawn them. We have done whatever. But it’s this idea of
if we have a message, write the letter and send it.

MR. BLAIR: It’s a heads up to the secretary that there is an issue.

MR. REYNOLDS: Yes, that’s what this is. Very short one Jeff.

MR. BLAIR: Okay.

MR. REYNOLDS: Just to say that an issue has come to

our attention. We know it has come to his attention in other letters.
Industry we’ve heard from some groups. We think that he needs to work with CMS
and others to monitor this as well as we will and in February we would give
further guidance. So, that’s kind of what we’re thinking.

MR. BLAIR: Okay.

MR. REYNOLDS: But again, let’s look at the letter. Let’s look at what it
says and what it does and whether it does. And if it doesn’t, then we obviously
withdraw before we even submit it. Some of things are getting to a point now
where things are moving so fast that the timing may not be exactly appropriate,
but waiting for the next one may not be appropriate either. That’s the hard
part of some of this journey that we’re having to go through, especially with
us doing it and then going to the full committee so we kind of get aligned with
what that is too. Stan are you good with what we’ve been saying so far?

DR. HUFF: Yeah, I’m fine.

MR. REYNOLDS: Okay. So that’s our plan that we’ve talked about and kind of
come forward with. So, I’d like to hear any other comments from anybody on
them. We will be talking. We’ve got plenty of action going on. It’s pretty
exciting actually. It’s good to have these many subject that are making a
difference. It’s better than just sitting here and not having anything happen.
And there are a number happening right now that may make it look like it’s fun.

MR. BLAIR: Harry, I think you’ve outlined a good play.

MR. REYNOLDS: Okay. Alright, Stan did you have anything else to add to the
meeting today?

DR. HUFF: I guess the question I had that Marjorie and I is who is going to
initiate the action there?

MR. REYNOLDS: Marjorie is initiating the action and using you as a subject
matter expert to make sure that we cover it appropriately since she was on the
committee, you would be our filter. One as a subject expert and two as a member
of the committee to make sure that the letter is discussed at a committee
level. So, since she’s on that actual committee, just a little bit like…

DR. HUFF: I wasn’t waiting for Marjorie to call.

MR. REYNOLDS: Yes, that’s correct. And she said she will have you something
within the next two weeks at the latest.

DR. HUFF: Great. I’ll wait for that.

MR. REYNOLDS: Okay. Michael?

DR. FITZMAURICE: Could you review the actual items. I apologize for not
being here.

MR. REYNOLDS: No, that’s fine. Here we go. One, CHI letter- Marjorie and
Stan. NPI letter- Karen and Harry. The Hippo Report- All of us. Because that
will be done by Jim Scanlon’s office and all of us will review that. The NHIN-
Simon, Jeff, and I are on that. The NDC rule would be Randy and Karen. That’s
it. That’s what we were saying. So we had a shorter than usual hearing and a
longer than usual to-do list. So, maybe we ought to have longer hearings from
now on. Might work out a little better.

Anything else anybody has to say? Or anybody from the audience have
anything they’d want to add?

DR. CARR: Harry, it’s Justine, I’m sorry I wasn’t able to be there for some
of the hearings yesterday, but if there are handouts or electronic summaries,
I’d appreciate getting them.

MR. REYNOLDS: Okay, Marietta will send that to you. I didn’t know you were
back on, Justine. Are you satisfied with our list of to-dos?

DR. CARR: Yes, I am.

MR. REYNOLDS: Are you upset that you aren’t on one of those.

DR. CARR: No, I’m not.

MR. REYNOLDS: Alright. Thank you, and meeting is adjourned. Thanks.

[Whereupon, at 11:50 a.m., the subcommittee meeting was concluded.]