1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
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:
In
the
Matter
of:
:
:
PUBLIC
HEARING
ON
THE
:
Docket
No.
:
20060158
2006
ESSENTIAL
USE
:
:
EXEMPTION
PROPOSED
RULE
:
:
METERED
DOSE
INHALERS.
:
:
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Friday,
April
21,
2006
Environmental
Protection
Agency
Room
152
1310
L
Street,
N.
W.
Washington,
D.
C.

The
hearing
in
the
above­
entitled
matter
convened,
pursuant
to
notice,
at
1:
01
p.
m.

BEFORE:

ROSS
BRENNAN,
Chief
Stratospheric
Program
Implementation
Branch
Stratospheric
Protection
Division
Environmental
Protection
Agency
2
C
O
N
T
E
N
T
S
SPEAKERS
PAGE
1.
STEPHEN
CAMPBELL
Armstrong
Pharmaceuticals...................
7
2.
PAMELA
WEXLER
U.
S.
Stakeholders'
Group..................
14
3.
KRISTEN
MORRIS
Boehringer­
Ingelheim.......................
17
4.
JAMES
A.
LOSEY
GlaxoSmithKline............................
18
3
P
R
O
C
E
E
D
I
N
G
S
CHAIRMAN
BRENNAN:
Good
afternoon.

I
think
just
about
everybody
is
here.
We
may
have
a
few
more
people
trickling
in,
but
we
might
as
well
get
started.

My
name
is
Ross
Brennan.
I
am
the
Chief
of
the
Stratospheric
Program
Implementation
Branch,

in
EPA's
Office
of
Atmospheric
Program.
We
are
the
folks
who
are
responsible
for
the
essential
use
program
at
EPA.

I'd
like
to
thank
everybody
for
attending
today's
hearing,
particularly
on
so
much
short
notice.

Specifically,
the
proposed
rule
that
is
the
subject
of
today's
hearing
is
the
proposed
rule
that
was
published
April
11,
2006,
Docket
No.
20060158.
The
proposed
rule,
as
you
no
doubt
know,
would
allocate
1002.40
metric
tons
of
CFC­
1112
and
1114
for
use
in
meter
dose
inhalers
specifically
in
the
year
2006.

As
you
probably
know,
the
purpose
of
today's
hearing
is
to
allow
interested
parties
to
4
provide
verbal
comments
to
EPA.
You
should
feel
free
to
provide
handouts
and
I
know
that
at
least
one
speaker
has
provided
handouts
as
well.
Those
handouts
will
be
included
as
a
part
of
the
formal
docket
for
the
rulemaking
and,
therefore,
are
incorporated
as
part
of
the
public
record.

As
we
assemble
the
final
rulemaking,
we
will
basically
consider
the
verbal
comments
we
receive
today
in
exactly
the
same
manner
that
we
will
consider
written
comments.
If
you
are
attending
the
hearing
and
you
wish
to
submit
written
comments,
feel
free
to
do
so.
If
you
are
speaking
today
and
you
wish
to
supplement
your
comments
with
additional
written
materials,

obviously,
feel
free
to
do
so
as
well.

Please
remember,
the
deadline
for
submitting
comments
is
May
22nd.
The
reason
for
that
date
is
because,
in
fact,
there
was
a
hearing
requested
for
today
and
for
that
reason,
the
deadline
for
submitting
comments
on
the
proposal
has
been
moved
from
May
11th
to
May
22nd.

As
a
reminder,
the
purpose
of
the
hearing,
5
again,
is
not
to
answer
individual
questions.
I
welcome
you
to
talk
to
the
members
of
my
staff
who
were
involved
in
the
MDI
program
for
essential
uses
offline.
If
you
have
further
clarifying
questions,

I
would
point
out
Hodayah
Finman
and
Kristen
Cappel
of
our
division
as
the
two
staff
leads
on
this
particular
issue.

By
now,
I
hope
everybody
is
signed
in.
I
hope,
certainly,
that
if
you
are
interested
in
speaking
that
you
have
checked
the
box
on
the
sign­
in
sheet.

I
have
here
two
individuals
who
have
requested
to
be
able
to
submit
comments
today.
The
first
is
Stephen
Campbell
and
the
second
is
Gretchen
Trout.
Is
there
anybody
else
who
is
interested
in
providing
comments
at
today's
hearing?

MS.
TROUT:
I'm
Gretchen
Trout
and
I
am
not
interested
in
providing
comments.

CHAIRMAN
BRENNAN:
Pam
Wexler,
perhaps?

MS.
WEXLER:
Did
I
check
that
off?
Yes,

right
now,
all
right.
6
CHAIRMAN
BRENNAN:
Very
good.

As
you
may
have
noticed,
we
do
not
have
a
microphone
in
the
room
to
amplify
speakers'
voices.

We
do
have
microphones
to
capture
people's
comments
for
the
public
record.
I
would
ask,
because
we
have
a
court
reporter
here,
that
you
speak
slowly
and
clearly
as
you
provide
your
comments;
that
you
begin
by
providing
your
name
and
that
of
the
organization.
Please
spell
out
your
name
if
it
is
a
difficult
name
to
spell.
Again,
recognize
that,

because
we
don't
have
the
microphone,
please
speak
slowly
and
clearly.

Because
we
do
have
a
court
reporter
for
today's
hearing,
we
will
have
a
transcript
of
today's
hearing
available
on
EPA's
website
and
we
expect
that
to
be
available
within
a
couple
of
weeks.
So,
you
can
look
at
epa.
gov/
ozone
for
a
posting
of
the
transcript
of
today's
hearing.

With
that,
I'd
like
to
begin
and
I
think
I
will
start
at
the
top
of
the
list
of
today's
speakers.
Mr.
Campbell,
I
understand
that
you
have
a
Powerpoint
presentation
that
you
would
like
to
7
provide
and
some
handouts
that
go
along
with
that.

MR.
CAMPBELL:
Actually,
at
this
point,
we
have
not
loaded
the
Powerpoint.
We
are
going
to
work
just
off
the
printed
materials.

CHAIRMAN
BRENNAN:
Very
good.
We
will
capture
your
verbal
comments
then
for
the
record
as
well
as
a
copy
of
the
paper
presentation
for
the
record.

Thank
you.

MR.
CAMPBELL:
Thank
you,
Mr.
Brennan.

On
behalf
of
Armstrong
Pharmaceuticals
who
I
am
actually
here
to
represent,
rather
than
Amphastar,
my
actual
employer.
I
would
like
to
thank
the
agency
for
this
opportunity
to
present
our
comments
publicly
in
this
type
of
a
forum.

My
name
is
Stephen
Campbell,

C­
a­
m­
p­
b­
e­
l­
l.
I
am
with
Amphastar
Pharmaceuticals,
the
parent
company
of
Armstrong
Pharmaceuticals.

I'll
start
with
a
little
bit
of
background,
but
I
think
most
of
the
people
in
the
room
know
that
background.
So,
I'm
going
to
move
8
through
it
very
rapidly.
If
I'm
moving
too
rapidly
for
anyone
but
the
court
reporter,
please
raise
a
hand,
because
the
reporter
can
get
this
off
of
the
written
materials.

The
reason
we
are
here,
as
you
know,
is
metered
dose
inhalers.
Albuterol
metered
dose
inhalers
are
used
as
a
rescue
medication
for
patients
suffering
from
asthma
and
from
chronic
obstructive
pulmonary
disease
or
COPD.
In
2005,

according
to
numbers
available
through
IMS,

approximately
59.84
million
Albuterol
MDIs
were
sold
in
the
United
States.
As
of
January,
2006,
21
million,
21.24
million
imported
units
were
lost
to
the
U.
S.
market.

A
shortage
of
Albuterol
MDIs
has
arisen
as
a
result
of
the
loss
of
these
imported
MDIs.

Armstrong,
at
this
point,
appears
to
be
the
only
CFC
MDI
manufacturer
with
sufficient
excess
capacity
to
meet
the
current
demands
for
CFC
MDI
Albuterol
inhalers.

It
is
important
to
note
that,
Albuterol
MDI
inhalers
lose
their
essential
use
status
at
the
9
end
of
2008
and,
therefore,
as
of
that
date,
there
will
be
no
more
Albuterol
CFC
MDIs.
Armstrong
supports
that
position
and
is
working
on
its
own
to
help
continue
to
supply
the
market
with
non­
ozone
depleting
MDIs
after
2008.

We
believe
at
this
point
that,
inadequate
amounts
of
CFC
propellants
have
been
allocated
for
2006
to
replace
the
loss
of
those
imported
MDIs.

Issues
for
HFA
MDIs
that
prevent
them
from
capturing
more
of
the
market
share
at
this
point
are
items
such
as
third
party
and
Medicaid
reimbursement.
In
fact,
as
we
will
see
later
when
I
show
some
numbers,
the
percentage
of
HFA
MDIs
in
the
marketplace
has
actually
steadily
decreased
over
the
last
four
years.

The
market
for
MDIs
over
the
last
four
years
is
split
up
primarily
among
Warrick,
which
is
the
generic
arm
of
Schering,
IVAX;
Schering
has
their
own
small
amount
and
Armstrong,
Armstrong
formerly
being
part
of
Andrx.
Total
CFCs
for­­
CFC
units
in
2002
were
40
million,
46.5
million
roughly
in
2003,
virtually
flat
for
2004
and
a
sudden
spike
10
in
2005
that
took
the
total
number
of
CFC
units
alone
to
over
58
million.

In
the
first
quarter
of
2006,
we
have,
of
course,
only
our
internal
numbers.
What
we
have
seen
in
the
first
quarter
for
Armstrong
is
1.6
million
where
last
year,
2005,
we
did
a
total
of
3.29
million
for
the
entire
year.
The
total
market
based
on
graphic
projections
for
the
first
quarter
is
somewhere
around
15
and
a
half
million,
which
is
moving
toward
better
than
60
million
units
for
this
year.

HFA
contributions
have
been
relatively
small.
IVAX
brought
theirs
on
the
market
last
year
and
did
about
.6
million.
Schering
has
been
out
there
the
longest
with
the
best
presence,
but
their
presence
in
that
marketplace,
again,
per
IMS
numbers
has
decreased
steadily
from
2.49
million
in
2002
to
less
than
a
million
in
2005.

The
total
market
share
has
also
dwindled
from
eight
percent
in
2002
down
to
two
percent
of
the
total
market
in
2005.
CFC
allocations
have
also
steadily
declined
during
this
period.
In
11
2001,
the
allocation
was
3,098
plus
metric
tons.

This
year
we
know
it
is
down
to
1002.4
metric
tons.

This
is
based
on
a
couple
of
misassumptions
[
sic].

That
is
what
I'm
really
here
to
talk
about.

In
the
first
slide,
titled
False
Hope,
we
thought
one
manufacturer
had
informed
the
U.
N.

committees
dealing
with
this
issue,
with
MDIs,
that
they
had
805
metric
tons
of
CFC
pre­
1996
available
for
sale.
Eventually,
they
sold
this
material
to
Honeywell,
but
there
were
restrictions
placed
on
this.
Only
four
firms
were
allowed
to
buy
this
material.

As
of
last
night,
we
reconfirmed
with
that
firm,
which
is
GlaxoSmithKline,
that
they
will
not
sell
that
material
to
anyone
other
than
the
four
firms
listed
in
the
joint
letter
sent
to
the
committee
by
both
GSK
and
Honeywell.

Interestingly,
as
we
get
into
who
those
firms
are,
you
will
notice
they
are
firms
that
have
no
use
for
the
material.

Another
issue
in
that
letter
is
that,

resale
of
that
material
from
a
company
that
is
12
authorized
to
buy
it
to
any
company
not
on
the
list
is
forbidden.

The
companies
eligible
are
Boehringer­
Ingelheim
Pharma.
Their
product,

Atrovent,
is
not
a
CFC
Albuterol.
INYX,
an
arm
of
Teva,
is
already
converted
from
CFC
Albuterol
to
HFA
Albuterol.
3M
has
converted
from
CFC
Albuterol
to
HFA
Albuterol.

Wyeth
manufactures
Primatene
Mist,
an
over
the
counter
epinephrine
product,
which
does
not
compete
directly
with
Albuterol
either
in
the
HFA
or
CFC
formulation.

So,
again,
the
firms
authorized
to
buy
this
material
have
no
use
for
it.
Those
firms
who
are
still
manufacturing
CFC
materials
are
not
permitted
to
purchase
any
of
this
material.
Those
are
notably
Schering­
Plough.

Schering­
Plough,
we
understand
and,
I
won't
speak
for
them,
but
only
to
state
our
understanding
is
that,
they
are
basically
at
capacity
on
their
lines
and
don't
intend
to
add
additional
capacity,
which
makes
sense
since
in
13
another
year
and
a
half
to
two
years,
this
product
is
going
to
go
away.
It
does
not
make
sense
to
invest
additional
capital.

The
other
firm
notably
off
that
list
is
Armstrong
pharmaceuticals.
Armstrong
has
excess
manufacturing
capacity.
We
have
a
shortage
of
CFC
propellant
due
to
some
shortsightedness
from
prior
owners
of
the
company.
As
late
as
last
night,
we
were
again
refused
access
to
the
GSK
formerly
owned
material.

In
conclusion
and,
unfortunately,
it
is
a
long
series
of
conclusions,
we
believe
that
FDA
and
EPA
failed
to
take
into
account
the
impact
of
the
loss
of
imported
CFC
inhalers
from
Ireland
when
IVAX
closed
off
manufacturing
at
the
end
of
last
year.
GSK
has
orchestrated
a
subterfuge,

convincing
the
U.
N.
and
the
EPA
that
the
pre­'
96
propellants
are
available
when
they
are,
in
fact,

not.

Both
FDA
and
EPA
failed
to
recognize
the
significance
of
the
loss
of
180
tons
of
CFC
propellant
through
the
Irish
manufacturing
site
14
although,
in
fact,
the
MTOC,
which
is
the
Medical
Technical
Options
Committee
within
the
U.
N.,

specifically
recommended
that
that
180
tons
be
added
back
into
the
U.
S.
allocation
for
2006.
The
result
is
a
significant
shortage
of
Albuterol
MDIs
for
the
treatment
of
asthma
and
COPD.

Armstrong
has
the
capacity
to
manufacture
10
to
12
million
CFC
Albuterol
units
a
year.

If­­
and
this
is
the
big
if­­
if
sufficient
propellant
is
available.
The
180
ton
allocation
recommended
as
replacement
of
the
EC
produced
MDIs
should
be
added
to
Armstrong's
allocation
for
the
year
2006
to
avoid
a
significant
shortfall
in
capacity
nationally
within
the
next
few
months.

Thank
you.

CHAIRMAN
BRENNAN:
Thank
you,

Mr.
Campbell.

[
Discussion
off
the
record.]

CHAIRMAN
BRENNAN:
I
believe
the
next
empaneled
speaker
is
Ms.
Pamela
Wexler.

MS.
WEXLER:
Thanks
very
much.

Good
afternoon,
my
name
is
Pamela
Wexler
15
and
I
am
here
today
to
speak
on
behalf
of
the
U.
S.

Stakeholders'
Group
on
MDI
transition.

The
Stakeholders'
Group
is
a
consortium
of
nine
patient
and
medical
professional
organizations.
Since
1997,
we
have
collectively
attempted
to
inform
both
the
domestic
and
the
international
policy
makers
on
how
to
achieve
a
transition
to
HFA
inhalers
that
is
smooth
for
patients.

First,
let
me
say
thanks
to
EPA
and
that
I
apologize
for
not
having
slides
or
written
comments.
Working
with
the
consortium
and
the
timing
of
this
hearing,
we
were
not
able
to
collaborate
in­
depth.
We
do
intend
to
submit
written
comments
to
the
final
rule.
So,
my
remarks
today
are
going
to
be
very
brief,
which
for
those
of
you
who
know
me
in
the
room,
will
be
a
surprise,

a
shock
for
you.

Very
brief,
the
main
point
that
we
want
to
communicate
today
is
that,
as
outlined
in
the
proposed
rule
that
EPA
has
published,
the
timelines
of
events,
as
described,
may
not
necessarily
take
16
into
account
the
most
current
information.
As
most
people
know
and
as
Mr.
Campbell
has
described,

there
have
been
some
very
recent
developments
regarding
Albuterol
in
the
marketplace.

It
is
not
clear
that
FDA's
estimates,
the
companies'
estimates,
the
FDA
estimates
or
EPA's
proposals
reflect
that
most
current
information.

In
fact,
from
what
our
reading
is
of
the
proposed
rule,
that
the
allocation
could
be
based
on
information
that
is
anywhere
from
six
to
12
months
old.
We
think
that
EPA
should
at
least
reconfirm
with
FDA
and
take
that
into
consideration.

The
second
point,
which
is
related
to
a
rapidly
changing
marketplace,
is
simple
to
reiterate
a
position
that
the
Stakeholders
have
always
had
and
continue
to
maintain.
That
is
that
in
an
environment
where
CFC,
raw
CFC
materials
are
finite,
that
there
really
needs
to
be
a
full
consideration
of
how
allocations
will
affect
moietiese
for
which
there
are
no
alternatives.

Upon
our
reading
of
the
numbers,
if
you
17
see
that
the
tonnage
being
authorized
for
2006
is
significantly
reduced
from
what
EPA
or
the
U.
S.

Government
requested
from
the
international
community
and
that
number
has
been
adjusted,
yet
the
lion's
share
of
that
1100
tons
is
still
being
sent
to
Albuterol.

We
would
just
encourage
EPA
to,
again,

consider
in
a
rapidly
changing
marketplace
whether
this
has
been
taken
into
account
when
looking
at
the
authorization
and
to
ensure
that
the
moietiese
that
really
need
that
Albuterol
will
have
it
whenever
they
get
to
the
reformulation
stage.

With
that,
again,
thanks
very
much
and
we
will
submit
our
comments.

CHAIRMAN
BRENNAN:
Thank
you,
Ms.
Wexler.

Is
there
anybody
else
in
the
room
who
would
like
to
speak
at
today's
hearing?

Please
come
forward
and
state
your
name.

MS.
MORRIS:
Hi,
Kristen
Morris
with
Boehringer,
B­
o­
e­
h­
r­
i­
n­
g­
e­
r
Ingelheim,

I­
n­
g­
e­
l­
h­
e­
i­
m.
I
just
wanted
to
offer
a
point
of
clarification
to
Mr.
Campbell's
testimony.
18
The
product
that
actually
we
are
using
CFCs
for
currently
is
for
Combivent.
Atrovent
is,

indeed,
phased
out
of
the
CFC.
That's
the
end
of
the
comments.
If
there
are
any
questions,
I'd
be
happy
to
take
any.

MS.
WEXLER:
Could
I
ask
a
question
about
the
appropriate­­
I
wanted
to
ask
her
the
expedience
of
the­­
Mr.
Campbell
said
that
only
firms
that
have
no
use
could
buy
them.
Is
it
possible
for
you
to
clarify
that
BI
has
no
use
for
the
CFCs
that
they
purchased?

MS.
MORRIS:
That's
to
the
point.
Yes,

the
purchase
of
the
CFCs
is
for
our
Combivent
product.
So,
we
do
have
use
for
the
CFCs
that
were
out
of
the
GSK
stockpile.

MS.
WEXLER:
Okay,
I
understand.

MS.
MORRIS:
Thank
you.

CHAIRMAN
BRENNAN:
Thank
you,
Ms.
Morris.

Is
there
anybody
else
who
would
like
to
provide
comments
today?

MR.
LOSEY:
My
name
is
Jim
Losey.
I
represent
GlaxoSmithKline.
19
I
wasn't
intending
to
make
comments
today.

We
will
be
submitting
written
comments
after
we
have
had
a
chance
to
more
fully
review
the
rule.
I
do
wish
to
make
a
brief
remark
regarding
Mr.

Campbell's
remarks.

On
behalf
of
Glaxo,
we
take
great
umbrage
and
profoundly
disagree
with
his
characterization
of
our
sale
being
a
subterfuge.
I
was
personally
involved
in
that
sale
and
the
negotiations
over
several
months.
I
kept
the
U.
S.
Government
involved
and
apprised
of
the
sale
and
its
terms
throughout
that
period.
The
terms
were
made
publicly,
were
publicly
disclosed
in
a
letter
to
UNEP.
That
letter
is
available.
Indeed,
I
can
fax
it
to
you
at
any
time.

There
is
nothing
hidden.
There
is
no
subterfuge
in
it.
It
was
GSK's
right
as
a
company
to
sell
its
goods
to
whomever
it
wanted
to.
Beyond
that,
we
have
many
reasons,
which
we
will
detail
in
our
comments,
why
we
chose
those
companies
which
you
have
just
heard­­
need
the
CFCs.

I
just
wanted
to
note
for
the
record
that
20
was
a
completely
above
board
sale
and
was
done
on
principle.

Thank
you.

CHAIRMAN
BRENNAN:
Thank
you,
Mr.
Losey.

Any
other
comments
on
the
proposed
rule
that
anyone
would
like
to
offer
today?

[
No
verbal
response.]

CHAIRMAN
BRENNAN:
If
not,
I
thank
you
all
very
much
for
coming.
I
remind
you
that,
within
two
weeks,
we
will
have
a
written
transcript
of
today's
hearing
available
on
EPA's
website.
Those
materials,
obviously,
will
be
included
in
the
docket
for
the
rulemaking
as
well.

Thanks
very
much
and
have
a
good
weekend.

MR.
KAST:
I'm
sorry,
did
you
say
the
transcript
will
be
available
on
the
web?

CHAIRMAN
BRENNAN:
Yes,
sir.

MR.
KAST:
In
two
weeks?

CHAIRMAN
BRENNAN:
In
two
weeks.

[
Whereupon,
at
1:
23
p.
m.,
the
hearing
concluded.]
