Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 65

DECLARATION of Amy A. Barcelo in Support re: 63 MOTION for Summary Judgment on Plaintiffs' First Supplemental Complaint.. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D (part 1 of 6), # 5 Exhibit D (part 2 of 6), # 6 Exhibit D (part 3 of 6), # 7 Exhibit D (part 4 of 6), # 8 Exhibit D (part 5 of 6), # 9 Exhibit D (part 6 of 6), # 10 Exhibit E (part 1 of 8), # 11 Exhibit E (part 2 of 8), # 12 Exhibit E (part 3 of 8), # 13 Exhibit E (part 4 of 8), # 14 Exhibit E (part 5 of 8), # 15 Exhibit E (part 6 of 8), # 16 Exhibit E (part 7 of 8), # 17 Exhibit E (part 8 of 8), # 18 Exhibit F, # 19 Exhibit G, # 20 Exhibit H, # 21 Exhibit I)(Barcelo, Amy)

virginiamycin.

determine whether to initiate formal withdrawal

proceedings.
that

explained

I

letter

2000

10,

February

The

Scientists.

Concerned

of

of

representatives

and

Henney

Jane

Dr.

Commissioner

FDA

2000

6,

January

a

during

made

I

which

feed,2

livestock

in

use

from

drugs

antibiotic

seven

of

withdrawal

for

prioritization

for

request

my

addressed

letter

That

2000.1

10,

February

of

letter

its

in

me

to

petition

the

to

related

infonnation

further

provided

CSPI

therapy.

human

compromise

may

that

resistance

antibiotic

of

transfer

and

selection

to

due

health

human

endanger

they

because

subtherapeutically

used

when

unsafe

of

uses

subtherapeutic

for

approvals

the

withdraw

FDA

that

requests

petition

The

Concerned

of

Union

the

and

Group,

Research

Health

Citizen's

Public

the

Trust,

Concerns

for

Center

the

of

behalf

on

1999

9,

March

on

Agency)

or

(FDA

Administration

Drug

and

Food

the

to

submitted

was

that

petition

citizen

the

to

response

tentative

second

the

is

This

Jacobson:

Dr.

Dear

20009-5728

D.C.

Washington,

W.

N.

Ave.,

Connecticut

1875

~7

MD

Rockvllie

SERVICES

HUMAN

&.

HEALm

OF

Second, if the Center

J The letter is included in Docket 99P-048SICP.
2 The seven antibiotics are penicillin, tetracycline, erythromycin, bacitracin, lincomycin, tylosin and

Lot

",,~!J

.-v

7'7/

to

additional

require

1999,

19,

August

dated

you

to

letter

a

Union

then

the

involving

meeting

""""'"

needs

CVM)

or

would

FDA

requested,

action

the

of

nature

response,

the

and

Trust

Concerns

Docket

petition.

your

to

response

final

a

issue

yet

cannot

we

tentative

first

my

In

nonprofit groups including CSPI, the Environmental

(Center

Medicine

Veterinary

of

Center

FDA's

complex

the

of

because

Suite

why

further

explains

Michael

First,

completed.

be

DEPARTMENT
Public Health Servk»

Food and Drug Administration

FEe 2 820m

Centerfor Sciencein the Public Interest
F. Jacobson, Ph.D.

300

99P-0485/CP

Science in the Public Interest (CSPI), the Environmental Defense Fund, the Food Animal

Scientists.

medically important antibiotics in livestock feeds. The petition alleges that the drugs are

Defense Fund, the Food Animal

identified virginiamycin as CSPl's top priority for withdrawal.

time to issue a final responseto your citizen petition. This second tentative response

In order for the Agency to withdraw a new animal drug approval, two processes need to

fonnal

the

undertake

then

must

it

proceedings,

withdrawal

fonnal

initiate

to

decides

completed

are

reviews

as

basis

drug

by

drug

a

on

denied

or

granted

be

only

can

petitions

withdrawal process required by statute. For legal, scientific and resource reasons,
withdrawal actions for the petitioned drugs need to be considered on a drug by drug basis.
Data and infonnation will need to be reviewed and analyzed for each drug. Thus the

is

approval

an

withdraw

to

action

initiate

to

whether

on

determination

Center's

The

and resources pennit.

things,
section

other
in

among
provided

if,

action.

as

withdrawn

unsafe,

is

be

withdrawal

a
drug

the

that

can

support

to
show

application

exist
data

drug

grounds

animal
scientific

or

new

statutory
approved
experience

An

whether

primarily an internal process, although participation by drug sponsors and the public may
be requested. This process may include. among other things. an in-depth review and
evaluation of available data and information related to the particular drug. collection of
additional data if needed. and a risk assessment These reviews will be used to determine

2(eX

51
l)(A), or if the drug is not shownto be safe(section512(eXl)(B)). If the Center
concludesthat a drug's approvalshouldbe withdrawn,it is requiredby section512(eXl)
drug,

individual

each

for

issued

ordinarily

is

NOOH

separate

A

(NOOH).

hearing

to provide the drug's sponsor with notice and an opportunity for a formal administrative

consolidated.3

be

may

drugs

related

chemically

involving

actions

although

drug,

becausemost of the relevant scientific evidence is likely to be unique to the individual

fonnal

a

requests

who

sponsor

A

hearings.

public

evidentiary

fonnal

with

dealing

Issuance of NOOHs and requests for a hearing are governed by the federal regulations

fonnal

a

section

an

the

of

withdraw
provision

to

to

conduct

will
appealed
under

Appeals

of

decision

be

officer
can

presiding

which

A
Commissioner's
Court

U.S.

the

decision,

hearing.

of

initial
the

to

appeal

an

notice

a

drug

may

render

issue
animal

sponsor

and

will
new

A

hearing

a

of

approval

Commissioner.

evidentiary

Commissioner

hearing is required to submit detailed data to justify the request. The request will be
reviewed and, if the Commissioner detennines that a hearing is justified, the

512(h).

separate

example,

For

NOOH.s

final

the

but
of

1971,

in
Withdrawal

issued

were
1991.4

until

approvals
issued

not

nitrofuran
was

of
approvals
NOOHs

(DES) approvals became fina1 in 1979, six years after issuance of an
.

diethylstilbeStrol

3

withdrawal

the

withdrawing

for

NOOHs

first
rule

The Agency's experience with contested, fonnal withdrawal proceedings is that the
process can consume extensive periods of time and Agency resources. For example, the

were issuedfor the proposed
withdrawalsof approvalfor nitrofurazone

(36 Fed. Reg. 5927, March 31, 1971) and furazolidone (36 Fed. Reg. 14343, August 4, 1971), but the

actionsinvolving bod! nitrofuranswereconsolidated hearing. See56 Fed.Reg. 41902(August 23,
for
1991).
4 See56 Fed. Reg.41902 (August 23,1991).
See44 Fed. Reg. 54851(1979).

,

2

to

process

extensive

an

undertaking

is

FDA

the

issues,

these

address

To

bacteria.

The Agency recognizes
that there are issuesrelatedto the role that antimicrobialdrug use
in food-producinganimalsplays in the emergence antimicrobialdrug resistant
of

use

antimicrobial

concerning

issues

addressing

effects
animals

microbial

the

of
food-producing

impact

in

health

drugs

a.nimal

human
new

potential
antimicrobial

the

One is Guidance for Industry 78 (GFI 78), which addresses

consider

of

uses

all

to

animals.

intends

with

FDA
associated

how

in food-producing

documents

two

prepared

has

Agency

The

evaluateissuesrelatedto the useof antimicrobialdrugsin both humansand animals,and
to developpolicies that protectthe public health.

for

framework

risk-based

conceptual

a

out

sets

which

"

Documen~

"Framework

when approving such drugs.6 The other is a discussion paper, referred to as the
evaluating the microbial safety of antimicrobial drugs intended for use in food-producing
animals.7 The Framework Documen~ if implemented, could apply to both drugs being

majority

The

parties.

interested

from

issues

these

on

comments

solicit

to

continues

FDA

considered approvaland previously approveddrugs. Further,asstatedin the two
for
documents, Agency is consideringall usesof antimicrobialdrugsin food-producing
the
animals.

of the general public comments received on the Framework Document agreed that the

robust

is

evidence

scientific

the

that

stating

comments

the

with

agrees

FDA

animals.

Agency shouldaddress issueof the useof antimicrobialdrugsin food-producing
the

2001.

9,

April

on

period

comment

public

the

of

close

the

before

comments

additional

enough to cause the Agency to further evaluate the microbial safety of antimicrobial
drugs intended for use in food-producing animals.8 Moreover, on January 22-24, 2001,
the Agency held a public meeting to discuss the use of antimicrobial drugs in foodproducing animals and the establishment of regulatory thresholds on antimicrobial
resistance. The Agency received many comments during the meeting and expects

~January

of

CVM's

the
1999,64

13,

of

in

based

supporting

poultry,

in

NOOH

an
December

Effects

as

use

factors
Microbial

published

die

of

Animals,"
Food-Producing

in

Impact

was

for

many

of

one
enrofloxacin,

is
Food-Producing

in

Healdl

proposal

That

Human

Use
Use

of

for

impact

health

human

the

models
assessment

risk
intended

of
887

Effects
Reg.

Fed.

64

Microbial

die

of
Animals,"

Safety

Human

die

Assuring
for

and
Intended

Drugs

Evaluating

17,1999).
for

Animal

Framework
New

Proposed

A

..
Antimicrobial

7

Fed. Reg. 70715 (December

infections associated with the consumption of

fluoroquinolone

this

the
"Consideration

Drugs

78,
Animal

Industry

for

New

concerns.

withdraw

from

Campylobacter

resistance

to

results

The
proposal
antimicrobial
Guidance
Antimicrobial

6

on

recent

chicken.9

fluoroquinolone-resistant

that

assessment

risk

a

developed

has

CVM

Several comments on the Framework Document support the use of risk assessments a
as
tool in decision-making for food safety issues. The Center has begun to apply risk
assessmenttechniques on issues related to antimicrobial drug resistance. For example,

6, 1999).

A completeanalysisof die comments die FrameworkDocumentcanbe found at www.fda.gov/cvm.
to
9 The risk
htlD://www

assessment

is available

on CVM's

.fda.2.ov/cvm/antimicrobiaVRisk

homepage
asses.bbn.

3

at:

in food-producing

virginiamycin

is

on January

a prototypic

the development

22,

risk

of streptogramin
has

withdrawal

than

for

more

priority

from

highest

comments

its

between

published

to develop

among

the

indicated

petitioned

that

drugs.

These

virginiamycin

NOOH

plans

Enterococcusfaecium in humans and the use of
animals. 12 As noted above, CSPI

resistant

received

a corrected

announced

to assess the association

(quinupristin/dalfopristin)

FDA

with

recently

people

model

Register,IO

the Center

38,000

assessment

Federal

petition.

In addition,

your

31, 2000,

2001.11

concerning

October

The Agency will issue a final response to your citizen petition upon completion of our
analysis of the comments received on your citizen petition, the Framework Document,
numerous consultations, and the resolution of the scientific, legal, and policy issues.

Ph.D.

.M.,

V

Ff.

Sundlof,

F.

Stephen

Sincerelyyours,

Director, Center for Veterinary Medicine

Trust

Concerns

Animal

Food

Identical letters were sent to:
Environmental Defense Fund
Citizen's
Health Research Group
Union of Concerned Scientists
Public

10 65

Fed. Reg. 64954(Oct. 31, 2000).

1166Fed.Reg. 6623 (Jan.22, 2001).

&

12See 65 Fed. Reg. 20992 (April 19, 2000).

a

makes
petition.

Agency

your

the

in

when

listed

denied

or

approvals

drug

granted

the

be

of

only

any

can
withdraw

petition

to

the
whether

above,

on

explained

decision

final

As

comments, as well as other relevant data and information, will have to be evaluated by
the Agency before any action will be taken. Therefore, at this time, it would be
premature to grant or deny the petition, in whole or in part.

HFV-I (2)

Steinberg)

/

-6

Tollefson

(Dawson

OGC-I

HFV

HFV-2

HFA-305

<:c:

Docket # 99P-0485/CPV
In dech/Hal ey /Mitchell

Final: ar/O2/27/01
w.