Download tember 8, 1997 kets Management Branch (HFA-305) d and Drug Administration

HSUS
GOV.
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No .001
tember 8, 1997
kets Management Branch (HFA-305)
d and Drug Administration
20 Parklawn IX.
Im 1-23
kville, MD 20857
3994
“97 ~EP-8
A9:X3
‘ood and Drug Administration Request for Comments
evelopmcmt of OptIons to Encourage Animal Drug Use
Approvals for Minor Species and Minor Uses
Submitted to Docket No. 97 N.0217
behalf of our 5 million members and constituents, The
nane Society of the United States (HSUS) offers the following
Iments on the Food and Drug Administration’s request for
Iments regarding the development of options to encourage
nal drug use approvals for minor species and minor uses.
.
passage of the Animal Medicinal Drug Use Clarification Act
994 (AMDUCA) was an impottant and necessary step for
Iring the continued ability of veterinarians to prescribe
alabel uses of approved animal drugs, and approved human
IS for animals, to treat conditions that are life threatening, to
we or prevent pain and suffering, and to treat otherwise
eatabie conditions, i.e. therapeutic uses,
mtrast, the primary purpose of The Animal Drug Availability
of 1996 (ADAA) as stated in the ‘Request for Comments’ is
acilitate the approval and marketing of new animal drugs and
icated feeds by building “needed flexibilit~ into the animal
review processes “to enable more efficient approval and
s expeditious marketing of safe and effective animal drugs.’’”
challenge continues to be to implement the AMDUCA and
fDAA within a regulatory framework that protects animal
th and well-being, public health and safety, and the
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environment, am
drug use while e
:the same time provides incentives to minimize extralabei
blishing a workabie and effickmt drug approval process.
The prlvllege of [
into routine use t
ve~ clear with th
proposing expan
other nontherape
and hormone US(
approach for the
and effective dru
“aiabel drug use was never intended to ailow drugs to be put
>ypassing the drug approval process. The agency should be
mbllc that this is exactly what Is being discussed when
n of extraiabei uses to those of enhanced production and
c uses. Given the current climate with food safety concerns
sues in the international arena, it wouid seem a more prudent
ency to direct regulatory energy into setting up an efficient
Ipproval process in which the pubiic can have confidence.
Extendirw existir
reproductive ~on
It is disconcertin~
use, given the e~
extraiabel reproc
“Extralabei Drug
eqai authority to permit extralabel use of medicated feeds or
nes and impiants:
~see these two issues raised again in the context of extraiabei
wive pubiic discussion both topics have received and that
live uses were specifically addressed in the finai rule for
e in Anirnais”,
First, regarding t,
purposes that wc
The agency did f
therapeutic” was
categories of rep
the definition oft
aquacuiture uses
Gomments advo~tlng extraiabel use for ali reproductive
reported in the final ruie on Extralabel Drug Use in Animais.
It out that the comment that “aii reproductive uses are
iced inmrrect. Additionaiiy, many of the future and growing
iuctive uses that would be covered by such an extension of
aiabel use wouid cleariy not be classified as therapeutic,
Maps being the best exampie.
The extralabel w
enhanced produ(
is such use outsl
a doubt be requi!
where economic
drug approvai sy
extraiabei drug u
]f reproductive hormones for aquacuiture is for purposes of
n such as spawning and gender reversai processes. Not only
of the scope of AMDUCA, but drug companies should without
to seek FDA approval when dealing with growing industries
vards are iikeiy, The solution is to deveiop a more efficient
m, not to expand the priviiege of and statutory intent for
to facilitate the growth of an industry,
The agency also
aquiculture indu
enhanced animal
of extra[abel use
effect of such brc
number of appro’
the agency: “ Th
pressed concern when addressing the initiai request of the
I to extend extralabei use to nontherapeutic uses such as
oductlon: “The agency, in considering the appropriate scope
der the statute, is concerned about the possible detenent
extraiabei use on the widely-shared goai of increasing the
i drugs that are avaiiabie for animal use.” And as stated by
ew legislation [the ADAA] shouid decrease the need for
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extralabel useof
nontherapeutic u
Jgs as more animal drug products for both therapeutic and
; are approved .“
Two other reasol
use of reproducti
new technology (
outside the realn
companies $houl
lucrative and gro
given by advocetes for expanded extralabel use, “extralabel
drugs conserves animal resources, and allows application of
I. embryo transfer and artificial insemination)”, are completely
‘ statutory intent for extralabel use. Futihermore, drug
~erequired to seek FDA approval when dealing with such
ig industries as those involved with “new technology”.
Again, the privile
drugs to be put ir
facilitate the grow
of extralabel drug use was never Intended to be used to allow
routine use by bypassing the drug approval process or to
of a particular animal indust~.
Antlblotlc resists
Many comments
comment period
expressed by the
(CDC) and a not[
Advisory Comml’
for infectious Dis
around the prude
concerns that: “..
public health as [
does not address
and for proiongel
~and drug use ~atterns
we received specifically on this issue during the pubiic
Extralabel Drug Use In Animals including concerns
ghly respected e?xpetisfrom The Centers for Disease Control
wthy comment from the chair of FDAs Anti-Infective Drugs
?and of the Antimicrobial Use and Clinical Trials Committee
se Society of America. These and other concerns centered
use of antimicrobial to reduce resistance and the CDC
s use of antimicrobial agents in animais presents a risk to the
ined in the proposed rule, and [noted that] the proposed rule
e hazard caused by the use of antimicrobial at low doses
eriods.”
The agency is to
some of these cc
such as the issuf
contribution of SL
antibiotic resists!
addressing these
commended for many excellent steps being teken to address
wns. However, other key Issues remain largely unaddressed
‘drug use patterns inciuding routine subtherapeutlc use, the
patterns to the extremely serious and grow}ng problem of
!, and the role of the FDA and the drug approvai process in
id related concerns.
In instances whe
agents has becol
drugs without asl
use.
~rugs have lost their potency, or resistance to certain disease
widespread, we should not simply continue to provide new
~ the hard and critical questions about current patterns of drug
equally relevant whether addressing drug use in minor
These concerns
species or in the:; : livestock sectors that are already well-established.
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II there are indeed unique aspects to be dealt with when
In conclusion, w il
addressing drug
use must clearly
being wrestled w t
If
1!
provals for minor species and minor uses, these categories of
dealt with within the context of the broader issues currently
as the AMDUCA and ADAA begin to be implemented.
We cannot lose i ht of the intent behind the passage of each of these acts and
the challenge to
plement the AMDUCA and the ADAA within a regulato~
framework that p tects animal health and well-being, public health and safety,
and the environ
nt, and at the same time provides incentives to minimize
extralabel drug u while establishing a workable and etiicient drug approval
process,
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