Dr. Oeller, thank you very much.
You're the Director of the Office of Minor Use and
Minor Species Animal Drug Development, in the Center
for Veterinary Medicine.
That's right.
Besides being a mouth full, you probably get the
prize for having the longest name of an office.
But what does it do?
Our office is a very small office.
Our whole staff is only three and a half people.
Therefore, minor use and minor species?
Right.
Which is really ironic, because minor species are
all species, this is actually in the statute,
that aren't major species.
So that's not too helpful on its own, until you know
that there are seven major species.
That's horses, cows, pigs, dogs, cats, chickens, and
turkeys, everything else is minor.
So we have aquaculture, zoo animals, lab animals;
we have game birds, sheep, goats, llamas, everything.
All of the stuff in the zoo, on from aardvarks to
zebras, including honeybees and many, many
animals of agricultural importance and a lot of
companion animals like ferrets and hamsters and
pet birds and aquarium fish, all of those things,
they're valuable and important to people
personally, and they are important to our economy,
but they're not economically worth it for
a pharmaceutical company to get a drug approved for them.
So, you're office is concerned with drug
development for those species?
Yes.
So, those species and I guess, drugs that have
limited distribution, limited use?
Well, it's a lot like the Orphan Drug Program for people.
As I said, it's not really worth it to a
pharmaceutical company for a market of how many sick
llamas are there.
The drug approval process is time consuming and it's
expensive and they need a good market to make their
money back, so our office largely manages incentive
programs for the pharmaceutical companies.
We've been talking with some veterinarians that
work with the circus and we're looking for some
drugs for elephants, but there not ready yet.
Most of the work that's been successful, has been
with these orphan drug incentives, giving
extended marketing exclusivity, we have a
grants program now, for uses that the
pharmaceutical company will get approved,
working, usually in partnership with someone
like the USDA's Minor Use Animal Drug Program or
some public hatcheries with US Geological Survey,
with US Fish and Wildlife Survey.
So there is taxpayer money going to do the
studies in a lot of these cases, but then the
companies are able to come in with their own
manufacturing and their labeling and use the
research data to get the drugs approved through the
regular process.
So, that's how we work it, on the incentive side of it.
Some of the things we have done recently, working
with the USDA's program, we got a couple of drugs
approved for American Foul Brood in honeybees.
What does that mean? What is that?
It's a disease that affects the larval bees,
and so we have some antibiotics that we've
gotten approved, so that we can treat the bees
outside of the time when they are making honey, and
they are able to cure this disease in the larvae.
You may have heard in the news a lot lately, that
honeybees are kind of having a bad time, so
anything we can do to help them out is really
important because they have billions of dollars
worth of impact on our agriculture.
So we've been working on drugs for honeybees, we've
been working on drugs for sheep.
We've been working on...
What's the problem with sheep?
Well, some of the things we've done for sheep are
respiratory disease antibiotics.
We've also worked on a drug that's a hormone that
helps synchronize breeding, so that farmers
aren't up day and night for months lambing, they
can synchronize and pretty much have the lambs at the
same time, and also when it's a little warmer, they
can shift things around a little bit,
giving them more control.
We have work going on for pheasants with gapeworm
and some toxcitia diseases, they are parasites
We have pheasants, partridges and quail that
we are all working on, all of those.
We have work going on for goats, with sheep and
goats it's usually respiratory disease or
foot rot or something like that, the way that it
often works is that the pharmaceutical company
will have a drug that's approved for cattle and
it's not really worth their while to do the
sheep and goats, but with the help from the USDA's
program we get the research done so that we
can then get an approval through the regular
process to supplement their existing cattle
label with sheep and goats.
I'm willing to bet that most people don't realize
that the FDA is involved with this at all.
That if they go on a farm or if they go in a
supermarket and see the results of what goes on at
a farm or if they go to the zoo that the FDA has a
firm role in all of this.
That's true.
And it is kind of I think, people sometimes think
that we conduct the studies and have the
animals in our building, which we don't, but we
work in partnership with universities, with the
pharmaceutical companies, with contract research
labs who are actually doing the studies to show
that these drugs are safe to the animal, safe to the
people who are administering the drug to
the animal, safe if it's a food producing animal,
if it's a goat, we have to make sure that the milk is
safe, we have to make sure meat is safe, if it's
poultry of any kind, that's not chickens and turkeys,
we have to worry about eggs and we have to
worry about the meat as well.
So with human food safety, we're also concerned about
antimicrobial resistance issues, where we don't
want antibiotics to be over used in animals on the farm.
So, we have to make sure we demonstrate that all of
these things are safe, if used according to label directions
And it's also important that we get these drugs
approved rather than use them under an extra label
provision which is legal in almost all cases, but
it's not as good, because we don't have established
withdrawal times; we don't have established dosage
regiments for the species that it's intended for.
So, it's much better to get the drugs approved and
anything that we can do to facilitate that,
we really want to do.
There are more and more exotic species that are
kept in confined spaces, so it's really important
that they be as healthy as they possibly can, to
preserve the species.
Right.
I'm a veterinarian and I know lots of veterinarians
that have expanded their practices into exotic
birds and reptiles and the pocket pets and the
ferrets and all those things that back in the
old days, back when I started veterinary school,
it was mostly farm animals and dogs and cats, but we
have a lot of these animals that people have
in their homes now and there's virtually nothing
approved for them.
And as I said, there is legal extra label use, but
it's often not in the proper formulation for those animals
or they don't know what the dosing should be.
So, it's really, really good that we can get
companies to work with us and get these drugs either
approved or indexed if it's a nonfood minor species.
And, as I said, we have the incentives to do it
and we have the cooperating programs, our
partners with USDA and universities and other
government agencies to try and get these studies done.
I see in your face and I hear in your voice a
certain excitement about what you do.
What's the source of that excitement?
Well, I do like to say, that I really do think
we're making a difference.
Being a bureaucrat is not exactly the same as, I
used to be a horse doctor, I used to go out and be on
the farms all the time.
And to go in and suddenly have an office job, I
thought was going to be fairly deadly, but it
turned out that it's never boring.
Every time the phone rings, it's somebody who
wants to get something approved to deal with
cattle fever ticks, which is a minor use in a major
species, down in Texas or it's somebody who wants to
get something approved for honeybees or someone who
wants to get something approved for their sick
pheasants, or their net-pen salmon, it's a
huge amount of variety.
And I've learned a great deal, I didn't know
anything about beekeeping and now I'm pretty good.
You really can make a difference.
We go out and do a lot of outreach.
We go to the sheep producers' annual
convention or the game bird producers' annual
meeting and we see what the actual needs are.
And so, we have the opportunity to help manage
these incentives and setup these partnerships, so
that we will actually see something go from a need,
all the way through the process to a drug approval
and something being marketed that will have an
impact that is good for U.S. agriculture,
it's good for our imports or exports, rather,
and it's a benefit to the animals, and as a
veterinarian, that's near and dear to me.
As a veterinarian, we are also concerned with public
health and we want to make sure that drugs are used
properly and that they are safe and people are using
things that have been demonstrated to work
and to be safe.
So, you know, a couple of times a year we actually
get something approved or listed on the index and we
can point to that as an actual achievement that we
have done, and I feel good about that.
I've been doing this now, I've been working minor
species pretty exclusively since 1995
and we've gotten a lot done.
There's a lot more to do, there are a lot of animals
out there, but we're working on it.