Amicus Curiae Brief — 9/1 Kg Containers, More or Less, of an Article of Drug for Veterinary Use, and Schuyler Laboratories, Inc v. United States of America

IN THE SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1988

9/1 KG. CONTAINERS, MORE OR LESS, OF

AN ARTICLE OF DRUG FOR VETERINARY USE, and

SCHUYLER LABORATORIES, INC.,

Petitioners,

UNITED STATES OF AMERICA,

Respondent.

ON PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES

COURT OF APPEALS FOR THE SEVENTH CIRCUIT

BRIEF OF THE AMERICAN FOOD ANIMAL

VETERINARY MEDICAL ASSOCIATION IN SUPPORT

OF PETITION FOR WRIT OF CERTIORARI

DAVID A. OLDFIELD

LeFevre, Zeman, Oldfield & Schwarm

Law Group, Ltd.

303 S. Seventh Street

P.O. Box 399

Vandalia, IL 62471

618/283-3034

Attorney for AMERICAN FOOD ANIMAL

VETERINARY MEDICAL ASSOCIATION

Se a ey

ty

NO. 88-614

IN THE SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1988

9/1 KG. CONTAINERS, MORE OR LESS, OF

AN ARTICLE OF DRUG FOR VETERINARY USE, and

SCHUYLER LABORATORIES, INC.,

Petitioners,

UNITED STATES OF AMERICA,

Respondent.

ON PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES

COURT OF APPEALS FOR THE SEVENTH CIRCUIT

BRIEF OF THE AMERICAN FOOD ANIMAL

VETERINARY MEDICAL ASSOCIATION IN SUPPORT

OF PETITION FOR WRIT OF CERTIORARI

DAVID A. OLDFIELD

LeFevre, Zeman, Oldfield & Schwarm

Law Group, Ltd.

303 S. Seventh Street

P.O. Box 399 ;

Vandalia, IL 62471

618/ 283-3034

Attorney for AMERICAN FOOD ANIMAL

VETERINARY MEDICAL ASSOCIATION

-ii-

A

TABLE OF CONTENTS

Page(s)

TABLE OF Ties 8 4k gk. rr

| ts Pree reer rrrey Peres? Te reo ee eee ee eT ee eae ee

EE EES FR SRK ES OSCE REE SEDER SHbECELOC OAR

LBBUG 6 06h 066664 ROO CES DODEDHOOOBO ROOD EEObOCOS

4 ey POeeere ee ee ee Pe ee ee ee ae a ee a ee a a ee ee eee

REGU he hs OOOO CKER OTRO RESCO HOSES OROOTASOCCOCED

A. The Seventh Circuit erroneously

interpreted the Food, Drug and Cosinetic

Act and blindly deferred to the misin-

terpretation of that Act by the

oo) rrr ess ee eee ee ae ee ee ee ee ee 2 ee eee

B. There is a long and ancient history

of the physician practicing his healing

arts, compounding chemicals to treat his =

Cg Ts ae ee ee err ee

Cc. It is the expressed intent of Con-

gress that the Food, Drug & Cosmetic Act

and the authority of the FDA in no way

interfere with the practice of the

WORSE OEERs wad ews ob eects ssheceacevessececee lO

D. The seized chemicals are not

"drugs" subject to the power of

the Ne ee a ee ee ee ee F |

E. The FDA regulations, when

properly interpreted in light of

the Act, exempt the chemicals

Eee GOLRUCO BY COO Fis sos cess seccveccvecs 22

-iii-

Ve

F. The FDA's attempt to regulate the

practice of veterinary medicine is in

direct contradiction to the United

States CONSCICUCION. ccccccccccsccscccccccccsccsal

G. FDA's unwarranted efforts to control

the practice of veterinary medicine will,

if successful, result in a public health

GiSasSteLe.ceccccccccccscscccscccccccccscsacsccsccsed3

H. Implementation of the Seventh

Circuit's opinion by the FDA will

have catastrophic effects for the

American DPT eCacketebhesecetebecseecumns sé hesene

=> = *) (o. Swear a ee

-iv-

TABLE OF AUTHORITIES

Page(s)

Constitution:

Tenth BRGRGRORE sc ccoccccesaesessssnsssecsntinae

CASES:

Capital Cities Cable, Inc. v. Crisp,

467 UeSe 691 [ROE a cases nessesedhescesésnresane

Cedars North Towers Pharmacy, Inc.

Ve U.Se,

No. 77-4695 (SD Fla. 1978)

printed in V. Kleinfield & A.

Kaplan, Federal, food, Drug,

and Cosmetic Act Judicial

Record 1978-1980 at 668... ccccccccccccccceeesd

Chaney v. Heckler,

718 F. 2d 1174 (D.C. Cir. 1983),

rev'd on other grounds, 470 U.S.

G2 CES pec ccc ees ceeereeeesesceceececcesese al

Chicago & N.W. Transp. v. Kalo Brick

& Tile Service Commission v. F.C.C.

101 Se Che 1124 EL 5 here rT TTTTTT Ss -

Conference at Federal Savings &

Loan Ass'n v. Stein,

604 F. 2d 1256 (9th Cir. 1979),

aff*d, 445 U.S. 921 (1980) .ccccccccccccceserdl

F.T.C. v. Simeon Management Corp.,

391 F. Supp. 697, 707 (N.D.

Cal. 1975), aff'd 532 F. 2d 708

COC CiG. BES wa cceeseceecdessccccacsenscsesead

Louisiana Public Service Commission

V. F.C.Ce,

106 Se ty 1890 (POO) 620006060060 6468-00080hean

-V-

i *

U.S. v. 9/1 Kg. Containers,

674 F. Supp. 1344 (C.D. Ill.

1987), rev'd, 854 F2d 173

(1966) ccccccsccesececesoscscesees 11,14,25,26

U.S. v. 9/1 Kg. Containers,

; 854 F2d 173 CEPSOP sb cb eseccanecentn ons céOe teaus

35,36,37,38,39,40

| U.S. v.e- Algon Chemical, Inc.,

(D.N.J. No. 87-1820 April 12,

1988), appeal docketed, No.

88-5478 (3d Cir. June 17,

2508) « ccerre eee eaten eosensccxves cdi 2osaeree

U.S. v. An Article of Device:

"Toftness Radiation Detector",

731 F.2d 1253 (7th Cir. 1984),

cert. denied, 469 U.S. 882.

; CESDS) 06 00 6h heen ee sa aebseeedeee sites eb 44 CAE

U.S. v. Article of Drug Designated

B Complex Cholinos Capsules,

362 F. 2d 923 (C. A. N. J.

L9GGdccacdesess cs eeeeceesadst est cseneesessavseseeut

U.S. v. Cockerill,

366 F. Supp. 856 (SD Ill.

Les Peer err rere erry rr Tee Pee eT eee ee ee ee ee |

U.S. v. Colahan,

635 F. 2d 564 (6th Cir. 1980),

cert. denied, 454 UseSe 2 re a ee gre eee a

U.S. v. Evers

453 F. Supp. 1141 (M.D. Ala. 1978),

aff'd 643 F. 2d 1043 (5th Cir.

EVOL 6 ccc d.6oneardweaeedesawads 462088 686 HOR ROE

U.S. v. Sene X Eleemossynary Corp.,

Inc.,

479 F. Supp. 970 (SD Fla.

1979) ccvccccccrccccecesecccccescsssesesessee se

STATUTES:

21 U.S.C. EVD PPPOE PPTTTPrrrereerererrerrry oo ee

21 U.S.C. SIS ll al (SPC B)eccccccccesccsceseseseeau

21 FS Fort i) > PP y ee ee yTPrrrrrrrre.er?ip clr...

21 U.S.Co $360. cece ccccsces co occececes 12,19,20

21 U-SeC.w. S374 a) ce ccccccccccscccccesessces 12,18

Ill. Rev. Stat. 1987, ch. lll,

par. 1, SPP PTPTTTrrTrrTrryTY reeerenttete © *© * @ 27,29

Iowa Code Ann. §§169.2,3,13 (West

Supp. 1986) cccccccsccevccese TUUTTELITITITTT TL 29

La. Rev. Stat. Ann. §§1511,13,26

(West 1974, West Supp. 1987) .cccccsccsesceess 29

Minn. Stat. Ann. §§156.081(12) (West

SUPP. 19ST) eccccccccccccesesscessxzeseseseses 29

REGULATIONS:

Hutt, Reguiat tr the Pract

Medicine Unde t Pur 3 1

Drug aws, 33, AS f

Urug JELTiciais «a *

,

*eeseieeewee#seee#fee#ees#fee#ee#e#fn°free#ee#eee#*# « «@

te

Morton, A Manual of Pharmacy for the

Student of Veterinary Medicine; con-

taining the Substances BEnployed at the

Royal Veterinary College with an

Attempt at Their Classification, and

the Pharmacopeia of that Institution

(Seventh Addition, Longmans, Green,

BG CO. 19GB) cccccccccceccccsesesacsescesoccscccesS

; 79 Cong. Rec. $5019 (daily ed. April

. 5, 1935) reprinted in A Legislative

| History of the Federal Food, Drug and

Cosmetic Act and its Amendnents, Vol.

Tt? 5

iv at a ee eeeweeenereremccetmUc rrmCrmlUcrrmCUc Cc OC rCUc Cc OC OC OCU Cc Cc TC CU mC OrmhUc rCUc Cc erhUc Cc rmhUchmLUchOLULmF »-

er

IN THE SUPREME COURT OF THE UNITED STATES

OCTOBER TERM, 1988

9/1 K G CONTAINERS,

more or less,

of an article of drug

for Veterinary use,

and,

SCHUYLER LABOR-

ATORIES, INC.,

Petitioners,

Ve

UNITED STATES OF

AMERICA,

ee eee eee ee

Respondent.

BRIEF OF AMERICAN FOOD ANIMAL VETERINARY

MEDICAL ASSOCIATION

IN SUPPORT OF PETITIONERS PETITION FOR

WRIT OF CERTIORARI

The Supreme Court must grant a Writ of Certi-

Orari in this case. It is imperative that

the Writ of Certiorari be granted because

there will be devestation in the food pro-

Jucing aninal populations which will result

2 sharp decline in the quality and avail-

ability £ meat, milk, and eggs which will

avery American. The Seventh

—— Laan

‘a

Circuit's incorrect interpretation of the

powers of the Food and Drug Administration

(hereinafter referred to as "“FDA") gives the

FDA unprecedented control over the practice

[eee

of veterinary medicine and will make it

impossible for veterinarians to practice

their healing arts in a legal, ethical man-

ner. The potentially devestating conse-

quences to our food supply of the Seventh

Circuit's decision cannot be over emphasized

and thus neither can the necessity for this

Court's review of that decision. Written

consent to file this Brief, Amicus Curiae,

has been given by both parties. ‘

I. INTRODUCTION

American Food Animal Veterinary Medical

Association is an [Illinois not for profit

corporation whose members are veterinarians.

The veterinarian profession will be directly

affected by the decision in this case. For

the food animal veterinarian the uunost con-

>

ts

control what veterinarians may prescribe for

their patients in disregard of the expressed

intent of the law?

III. FACTS

Certain chemicals were seized by the govern-

nent from the Petitioner, Schuyler Labora-

tories, Inc. (hereinafter referred to as

"Schuyler" ). The government complained that

these chemicals were misbranded under 21

U.S.C. §352(£)(1) because the packaging did

not contain adequate directions for use. In

addition the government complained that five

(5) lots of the chemicals were adulterated as

a matter of law because they were antibiotic

irugs. Appendix of Appellant filed in the

Seventh Circuit at 2.

For 16 years Schuyler has been in the busi-

ness of providing pure bulk materials to

veterinarians to use in their practice. The

FDA has all along been familiar with the

business of Schuyler. There is no question

regarding the Purity of the Chemicals nor is

there any question that the chemicals were

meant to be distributed in bulk to veter-

inarians to be used in their practice and not

to laymen. Supplemental Appendix of Appel-

lees filed in Seventh Circuit (hereinafter

Cited as "Aee") at 00017, 18, 19,

Finally, there is a total lack of evidence to

imply that the Chemicals in general are ille-

gal; that residues were occurring in milk,

meat, Or eggs as the result of the use of

these chemicals by veterinarians; or that

there is a Public health threat caused Dy the

veterinarians’ long-standing Practice of

compounding medications from bulk drugs.

IV. ARGUMENT

While the statutes and terms in the irug area

are complicated, the ultimate issue in this

case is quite Simple. It is simply a jues-

a

tion whether the educated, licensed, and

experienced professional veterinarian is in a

better position to make judgments regarding

the treatment of food animals or are such

decisions to be made on a mass level by the

bureaucrats of the central government. We

are not questioning the FDA's authority to

act against practices which will cause resi-

dues in the food supply or to otherwise

protect public health. That is not the issue

here and no where has the FDA contended that

the health of the consuming public is the

issue. It is simply whether the FDA can

control indirectly what the veterinarian may

prescribe in the course of his healing arts

by controlling what chemicals are available

to the veterinarian when the FDA cannot

A. The Seventh Circuit erroneously inter-

preted the Food, Drug, and Cosmetic Act and

ta

blindly deferred to the misinterpretation of

that Act by the FDA. The opinion below

admits that the FDA is trying to do in this

case what it has not done before in control-

ling the practice of veterinary medicine.

The lower court acknowledges the damage which

the FDA's interpretation of the Food, Drug &

Cometic Act (hereinafter referred to as

"Act") will do to food producing animals and

the shackles which will be placed upon vet-

erinarians. Although the briefs presented to

the Seventh Circuit presented a rather exten-

sive analysis of the history of the Act, the

Seventh Circuit essentially ignored that

history and instead provided a novel inter-

pretation of that history so that the inten-

tion of the Act not to interfere with the

practice of the healing arts is narrowed to

the point where only medical licensure and

discipline continue to be outside the pro-

vince of the FDA. Not even the FDA has been

gh a Hon

le

so bold as to assert this kind of authority

yet that is the position put forth in the

Opinion by the Seventh Circuit. While defer-

ence is due an administrative body, blind

grants of power by the courts should not be.

A proper review of the Act clearly shows that

the FDA should not be kimiting what veter-

inarians can prescribe for their patients

within the realm of their professional prac-

tice.

B. There is a long and ancient history of

the physician practicing his healing arts,

compounding chemicals to treat his patient

(whether human or animal). In recognition of

this fact, Congress specifically provided

exemptions for the practitioners of the

healing arts, and not until recently has the

FDA tried to do indirectly what it is not

allowed to do directiy--controlling what a

veterinarian may prescribe for his patient by

controlling the bulk chemicals which the

re

veterinarian may acquire. The use of bulk

drugs to compound aedications has been done

since the primitive beginnings of the healing

arts and is absolutely essential to the

practice of veterinary medicine. There is no

precedent for what the FDA is attempting to

do in this instance. Aee at 00033.

Veterinarians, since the beginning of their

profession, have handed down compounds’ to

each generation. Early texts on veterinary

medicine dealt w eth Ceesoundiaas The train-

ing of veterinarians in compounding has

literally gone on for hundreds of years and

continues today in both the formal education

requirements of veterinarians and in their

continuing education once a veterinarian is

in practice. Aee at 00027, 3l, & 36.

l1/Morton, D.J.T., A Manual of Pharmacy for

the Student of Veterinary Medicine; contain-

ing the Substances Employed at the Royal Vet-

erinary College with an Attempt at Their Clas-

sification, and the Pharmacopeia of that In-

Stitution(Seventh Addition, Longmans, Green,

& Co. 1868).

tr

C. It is the expressed intent of Congress

that the Food, Drug & Cosmetic Act and the

authority of the FDA in no way interfere with

the practice of the healing arts. ‘The con-

gressional intent in the Act is to protect

the public from harmful or ineffective pro-

ducts. The FDA is charged with the respon-

sibility of carrying out the congressional

intent of the Act. The legislative history,

the Act, and its Amendments are replete with

instances in which the practitioner of the

healing arts is exempted from the require-

ments of the Act and the oversight of the

FDA. The veterinarian falls within these

exemptions. The veterinarian (along with

other licensed professionals) is exempted

from the purview of the Act because Congress

recognized the unique relationship between

the doctor and the patient and the unique

responsibility which the doctor carries in

this relationship. The Seventh Circuit

~

"eo

Opinion misses the point when it discusses

FDA's judgment and the necessity of following

it. It is the expressed intent of Congress

which the courts must follow regardless of

the judgment of FDA.

In the District Court Judge Richard Mills

ably and thoroughly reviewed the history of

the Act, the duties of the FDA under the Act,

and the power given to FDA. In the six (6)

years of debate prior to the passage of the

Act, the special coneern of not interfering

with the practice of the healing arts was

thoroughly explored. Dr. Royal Copeland

guided the Act through the years of congres-

sional debate. When questioned in the Senate

whether the Act would apply to medications

prepared by a doctor in his practice, Senator

Copeland stated, “There is noting in the bill

which would interfere at all with the ordin-

ary legal practice of the profession." 79

Cong. Rec. 5018-5019 (1935).

-l|l]-

to

The statute contains exemptions for practi-

tioners of the healing arts. 21 U.S.C.

§374(a) and 21 U.S.C. §360. In subsequent

amendments to the Act, Congress has had ample

Opportunity to amend the Act to grant power

to the FDA to control the various profes-

sionals in the healing arts. Congress has

not seen fit to do so and furthermore has not

discussed the possibility. In 1962 Congress

passed Amendments to the Act, Pub. L. 87-781,

76 Stat. 781 (1962), which granted greater

power to the FDA. Although the power of the

FDA was expanded by the 1962 Amendments, the

exemptions for the healing arts remained. In

the 1968 Animal Drug Amendments, Pub. L. No.

90-399, 82 Stat. 343, Congress consolidated

provisions of the law. Again, Congress did

not tamper with the protection given to the

practice of the healing arts. The lower

court opinion makes much adieu about the fact

that there was no specific discussion about

/

j

j

not interfering with the healing arts when

the Act was amended. Why should there have

Deen any such Siscussions? For three (3)

Gecades there had deen no such interference

The FDA has recognized it does not Nave the

authority to interfere with tme practice of

the healing arts. In 1969 (Shortly after the

Passage of the Animal Drug Amendments)

The legislative history of the...Act of 1938

iS replete with statements that the Statute

“as not intended to regulate the Practice of

medicine. The "an who guided the legislation

tmrough the Congress, Senator Royal Copeland,

wes @ physician, anc was undoudtedly con-

cerned abour interfering “ith his proftes-

Sion.... Through the Six (6) years of legis-

the .

fail to show a CONsressiona! imtemt thet thi«

>be used to restrict the COMGitions for Mich

PMysicians ™@y prescribe Grugs., but it Flat ly

contradicts any such interpretation. In

enacting the 1938 Act Congress clearly in-

tended to avoi¢g *@Pinging on the Practice oF

-jl }-

SOureaucratic function would never make a mis-

take, Congress has Getermined that the FDA

~

v

Ss not to interfere with the Practice of the

nealing arts which includes veterinary med-

icine. The FDA should not be allowed to

-ircumvent this congressional intent Dy keep-

“J

rw

"

Vv

a

s

eCerinarians bulk chemicals which

they need to som pound Prescriptions which is

~Nactiy what will occur if the Seventh Cir-

7410'S opinion is left Standing.

D. The seized chemicals are not “drugs* sub-

Ject to the power of the Fpa. The chemicals

Seized by the government are not “new animal

2rugs” because in tneir bulk form these chem-

-4i8 are not sntenced for use for animals.

2 > S$32liw PTOVides that new animal

irug* means irugs intended for ise for

animals The chemicals S@ized by the jOovern-

sent are nor antenced for use for animals Sut

fatner must be -Ompounded by a veterinarian

pounds will be used. In U.S. v. Algon

Chemical, Inc., No. 87-1820 (D.N.J. April 12,

1988), appeal docketed, No. 88-5478 (3d Cir.

June 17, 1988), a case almost identical to

the present case, the Court stated, “The

language of [§321(w)] clearly indicates that

the term “new animal drug” applies only to

drugs which are manufactured in a finished

dosage form and not to bulk ingredients used

in compounding by veterinarians." The

chemicals are not intended for use for

animals and thus, these chemicals are not new

animal drugs.

Purther, 21 U.S.C. §321l(w)(1) provides that a

new animal drug means a drug intended fo

ry

wi

@

for animals the composition of which is recog-

instruct the lay user of the drug on its use

since the lay user is not familiar with the

drug. Schuyler is neither in a position to

nor could it instruct through labeling a

veterinarian on how to use ae particular

chemical. Aee at 00018. The veterinarian

must determine how that chemical will be used

including the compounding of the chemical

into a drug, the particular dosage to be

used, and the particular treatment regimen

which is to be used. Aee at 0027. "Newness"

is dependent upon the labeling and frequently

there are no labels at all for the medica-

tions compounded by the veterinarian, par-

ticularly those compounded in the _ field.

Whether labeling contains "adequate di-

rections of use" so as to avoid misbranding

must depend upon for what use the chemicals

are intended. U.S. Vv. Article of Drug

Designated B-Complex Cholinos Capsules,

C.A.N.J. 1966, 362 F.2d 923. Thus, the

Ps Qe

"newness" for the animal drug and the basis

for the FDA seizure is dependent upon the

labeling. Labeling by Schuyler to instruct

its customer, the veterinarian, is absurd.

In addition to the expressed congressional

intent in the legislative history, the Act

shows that the healing arts are not to be

subject to the provisions of the Act or the

power of the FDA. At 21 U.S.C. §374(a) the

Act grants inspection authority to the FDA.

Specifically excluded from such inspections

at subparagraph (2) are practitioners licen-

sed by law to prescribe or administer drugs

and who manufacture, prepare, propogate,

compound, or process drugs solely for use in

the course of their professional practice.

If bulk chemicals are new animal drugs and

veterinarians are unable to obtain’ these

chemicals to compound their medications, then

this exemption from inspection is meaning-

less. Congress could not have intended that

#19-

a physician may compound medications but may

not obtain the raw materials to do such com-

pounding. Such an interpretation of the law

would be irrational. Thus, the intent of

Congress to exclude veterinarians from such

inspections is clear and is part of the over-

all intention of Congress that veterinarians

not be within the regulatory authority of the

FDA.

The exemption of those of the healing arts

from the provisions of the Act are further

shown in relationship to the registration of

those who make drugs. Registration is re-

quired under 21 U.S.C. §360(a)(1) for those

who make drugs. Again, as with the inspec-

tion power, the power of the FDA relating to

such registration is limited in that there is

an exemption for legally licensed practi-

tioners who prescribe or administer drugs and

who manufacture, prepare, propagate, compound

Or process drugs solely for use in the course

-19-

of their professional practice. 21 U.S.C.

§360(g)(2). Exemption from registration be-

comes meaningless if a veterinarian must ob-

tain FDA approval of each drug he compounds

because it becomes a new animal drug. This

is illogical. Necessarily if the veterinar-

ian is exempt from registration, he must also

be exempt from the FDA approval requirements.

The registration exemption cannot be separ-

ated from an exemption for approvals.

The Act requires that drugs be handled under

good manufacturing practices (21 U.S.C.

§351(a)(2)(B)); however, the FDA has accepted

that these requirements do not apply to prac-

titioners of the healing arts. (50 Fed. Reg.

27,021(July 1, 1985)). One must not confuse

the compounding of medications by the practi-

tioner of the healing arts as allowed by the

Act with manufacturing of drugs as is done by

retail drug houses. One must differentiate

between the professional, individual act of

-20-

terete ieee

the compounding of medications by the veter-

inarian with the mass production, consumer

Orientation of the manufacturing process

carried on by the retail drug houses. If the

veterinarian cannot obtain the raw materials,

he will not be able to compound his prescrip-

tions and there would be no need for hin to

be exempted from the good manufacturing

practice requirements.

A final and most recent expression of congres-

sional intent regarding whether it is to be

the veterinarian or the federal bureaucracy

who determines what agents will be used on

food animals occurred in 1985 with the pas-

sage of the Food Security Act of 1985 in

which the Secretary of Agriculture was given

jurisdiction over shipments of animal bio-

logics through licensure but veterinarians

were exenpted from such licensure. With the

animal biologics the veterinarian is actually

dealing with the disease producing organism

-2?l1-

which may even be fatal to man yet the veter-

inarian is exempted from the licensing re-

quirements when dealing with these biologics.

This recent expression of congressional

intent shows that Congress has determined

that it is the veterinarian in whom Congress

relies upon to _ protect the food animals

rather governmental agencies.

E. The FDA regulations, when properly inter-

preted in light of the Act, exempt the chemi-

cals from seizure by the FDA. Zi Cu eRs

§201.122 issued by the FDA exempts’ bulk

products from labeling requirements. 21

U.S.C. §352 provides that a drug is deemed to

be misbranded unless its labeling bears

adequate direction for use. But if labeling

for adequate direction for use is not neces-

sary, the Secretary (of Health & Human Ser-

vices) shall promulgate regulations exempting

such drugs from the labeling requirement. 21

C.F.R. §201.122 provides an exemption for

>

i

drugs in bulk from the requirement that their

labeling supply adequate directions for use

in compliance with §352(f). This regulation

requires that the bulk materials be labeled

"For manufacturing, processing, or repack-

ing". This is the fact pattern of the in-

stant case. The bulk materials received,

repacked, and shipped by Schuyler to only

veterinarians are not intended for use. But

rather these chemicals must be compounded by

the veterinarian into a final dosage form,

Aee at 00018. Thus, the chemicals seized

from Schuyler meet the criteria of this regu-

lation for exemption of bulk products from

the labeling requirement.

The FDA in its attempt to regulate the veter-

inary profession relies on an exception to

the exemption set forth in 21 C.F.R. §201.122

to the effect that the exemption will not

apply unless the one who will be using the

Substance has an approved new drug appli-

~ ko

cation. It is the recent change in the

interpretation of this exception to the

exemption that FDA bases its quest for auth-

Oority over the veterinarian. As has been

shown the legislative history, the expressed

intent of Congress in the Act, and even the

admissions of the FDA all indicate that

veterinarians are not subject to the Act and

the authority cf the FDA so long as the vet-

erinarian is acting within the bounds of his

practice. Through this new interpretation of

the exception to the exemption, FDA is at-

tempting to control how the veterinarian

practices his healing art. The exeception to

the exemption is not necessary to protect the

public health when it relates to practi-

tioners of the healing arts. Congress has

made this group beyond the grasp of the FDA.

This new interpretation of the FDA to the

exception to the exemption has been rejected

by Judge Mills in his opinion for the Dis-

-24-

72

trict court in this case and was rejected by

Judge John W. Bissell in Algon. Algon is

almost identical to the instant case and both

District Court judges have come to the same

conclusion. The FDA is wrong.

Both Judge Mills (instant case) and Judge

Bissell (Algon) carefully analyzed who had

the burden of proof relating to the exception

from the exemption provided by 21 C.F.R.

§201.222. These judges relied upon United

States v. An Article of Device: "Toftness

Radiation Detector," 731 F.2D 1253(7th Cir.

1984), cert. denied, 469 U.S. 882 (1984).

Both Courts found that the burden of proof

would be on the claimant unless the exception

to the exemption was contrary to either the

letter or the intent of the law. Both judges

determined that the exception to the exemp-

tion was contrary to both the letter and the

intent of the statute and was not applicable

to veterinarians. Judge Mills specifically

-25—-

stated at Page 11 of his opinion, "The reg-

ulation is consistent with the statute to the

point of exempting bulk drugs from the gen-

eral labeling requirements. However, with

respect to this claimant--a seller of bulk

drugs to veterinarians--the limitation of the

exception (i.e., that ‘new drugs’ are not

exempt) is unreasonable and arbitrary and,

therefore, a nullity." (emphasis added).

Similarly the Algon court found, "The ex-

ceptions to the basic exemption are not

consistent with the statute under which this

regulation was promulgated. Therefore, in

order to give reasonable meaning to the

exempting regulation, consistent with the

Act, the Court finds that only that portion

which exempts bulk drugs from the labeling

requirements of 21 U.S.C. §352(£)(1) applies

to bulk drugs supplied for use in the prac-

tice of veterinary medicine". (Emphasis

added). Aee at 00013.

«Pin

mn i

F. The FDA's attempt to regulate the prac-

tice of veterinary medicine is in direct

contradiction to United States Constitution.

The Tenth Amendment to the Constitution

States that "“[t]he powers not delegated to

the United States by the Constitution, nor

prohibited by it to the States, are reserved

to the States respectively, or to the

people.” U.S. Const. Amend. X. The regu-

lation of the practice of veterinary medicine

is a valid exercise of the police power of

the states. See, e.g., Ill. Rev. Stat. 1987,

ch. lll, par. 7001;2 See also U. S. v. Cock-

erill, 366 F. Supp. 856 (S.D. Ill. 1973);

2/This section of the [Illinois Statutes

States “The practice of veterinary medicine

in the State of [Illinois is declared to

affect the public health, safety and welfare

and to be subject to State regulation and

control in the public interest. It is fur-

ther declared to be a matter of public in-

terest and concern that the veterinary pro-

fession merit and receive the confidence of

the public and that only qualified and li-

censed persons be permitted to purchase

veterinary medicine."

aa

U.S. ve. Colahan, 635 F. 2d 564 (6th Cir.

1980), cert. denied, 454 U.S. 831; U. S. v.

Sene X Eleemosynary Corp., Inc., 479 F. Supp.

970 (SD Fla. 1979); Cedars North Towers

1978), printed in V. Kleinfeld & A. Kaplan,

Federal Food, Drug, and Cosmetic Act Judicial

Record 1978-1980 at 668; U. S. v. Evers, 453

F. Supp. 1141 (M.D. Ala. 1978), Aff'd, 643

F.2d 1043 (5th Cir. 1981); F.T.C. v. Simeon

Management Corp, 391 F. Supp. 697, 707 (N.D.

Cal. 1975), aff'd, 532 F.2d 708 (9th Cir.

1976); and Chaney v. Heckler, 718 F.2d 1174

(D.C. Cir. 1983), rev'd on other grounds 470

U.S. 821 (1985).

FDA's interpretation of the Act would impinge

upon the regulatory schemes of the states,

which license veterinarians to administer

medicines in accord with professional stan-

-28-

jon The states require that the veterin-

arians they license exercise professional

judgment in treating patients. The conflict

with the requirements inherent in FDA's

interpretation is apparent. To illustrate

the point it would be considered inhumane to

perform general surgery on a cow without

using a anesthetic -- a veterinarian who

attempted such surgery would be subject to

discipline under state law and liable for

malpractice -- yet there is no approved

general anesthetic for such use, and under

its current policy FDA would consider pro-

secution of the veterinarian should he an-

esthetize the cow.

3/See, e.g., Iowa Code Ann. £§169.2, 169.3,

and 169.13 (West Supp. 1986); La. Rev. Stat.

Ann. §§1511, 1513, and 1526 (West 1974, West

Supp. 1987); and Ill. Rev. Stat. 1987, ch.

lll, par. 7001 et seq.

4/Some state statutes specifically mention

cruelty to animals or conviction of such a

crime as grounds for revocation of a veter-

inarian license. See, e.g., Minn. Stat. Ann.

§156.081(12)(West Supp. 1987).

-29-

The manner in which FDA seeks to force vet-

erinarians to practice would constitute

incompetence and malpractice. FDA would have

veterinarians treat animals only with FDA-

approved drugs or refuse to treat animals

altogether while the veterinarians knew of

safe and effective drugs to cure these ani-

mals. Such practice would lead to the loss

of many families. In addition the safe,

abundant food supply which we presently know

would disappear. Could the same Congress

that said the Animal Drug Amendnents "would

not usurp any State authority” intend these

results?

Agencies such as FDA may preempt’ state

schemes of regulation, if Congress has pro-

vided for it. Capital Cities Cable, Inc., v.

Crisp, 467, U.S. 691 (1984). However, pre-

emption of state law by a federal agency is

not favored, absent an expresssion of clear

intention of the Congress to substitute

-30-

federal authority. Louisiana Public Service

Commission v. F.C.C., 106 S.Ct. 1890 (1986);

Chicago & N.W. Transp. v. Kalo Brick & Tile,

L0i Ss Ct. 1Li2zd (i901).

It is not enough for the agency to argue that

the action is the best way to effectuate a

federal purpose. Louisiana Public Service

Commission v. F.C<C., &@¢ 1901. There must be

an unmistakable preemption in the congres-

sional grant of authority in order for a reg-

ulatory agency to assume authority that

detracts from a state scheme of regulation.

Chicago & N.W. Transp. v. Kalo Brick & Tiie,

at 1130. The starting point for analysis

when traditional police powers such as the

regulation of the healing arts are involved

is with the assumption that Congress did not

intend to preempt, and that its intent to do

so must by crystal clear for such an asser-

tion to be sustained. Conference of Federal

Savings and Loan Associations v. Stein, 604

-3l-

F.2a@ 1256. (9th Cir. 1979), aftt*d, 445 U.S.

921 (1980).

The authority cited by FDA for its attempt to

control the oractice of veterinary medicine

does not meet the tests enunciated by this

Court. The agency's confused approach to

arrive, so many years after the Animal Drug

Amendnents' enactment, at this newly-announ-

ced policy underscores the lack of any con-

gressional direction to require FDA to con-

trol the veterinarians' use of medicines.

Congress never intended to make the FDA the

arbiter of veterinary medical practice, and

FDA cannot confer the power upon itself.

Louisiana Public Service Commission Ve

F.C.C., at 1901.

The agency's attenpt to control an indispens-

able, integral part of the practice of veter-

inary medicine without the sanction of Con-

jress' is a violation of the Tenth Anendment.

atin

G. FDA's unwarranted efforts to control the

practice of veterinary medicine will, if suc-

cessful, result in a public health disaster.

The partnership over the past 50 years be-

ven the FDA and the veterinary profession

has resulted in a safe, abundant supply of

meat, milk, and eggs. During this time the

FDA has not in any manner regulated the vet-

erinarians. This mutual partnership = and

respect over the past 50 years has been of

great benefit to the public.

While the past has seen a harmonious rela-

tionship between the FDA and veterinarians,

the FDA in its present stance has turned upon

this relationship which has worked for the

benefit of the consumer. There has been no

activity on the part of the veterinarians nor

concern about food safety which would cause

concern by either the public or the FDA so as

to warrant the FDA's attempt to extend its

authority over veterinarians. The present

«3%

HRs es

grasp for power by the FDA is unprecedented,

unnecessary, and unlawful. FDA's interpre-

tation of the Act would make it impossible to

oractice the healing art of veterinary medi-

cine. There are sinply not enough approved

drugs. Aee at 00022. The choice is~simple.

Elther we continue the past practice which

nas resulted in the best and safest supply of

milk, neat, and eggs ever known to man or we

follow a course of action which will imme

diately result in devistation to the food

oroducing aninals.

FDA's interpretation of the Act makes it ille-

gal for veterinarians to prescribe medica-

tions other than as directed on the label of

the drugs that FDA has approved. Of the

20,000-30,000 animal drugs only 1400 are ap-

oroved of which only approximately 700 are

approved for the use in food animals and of

a#nich enly 49 are prescription drugs used by

veterinarians. The rest are sold over-the-

-34-

a

counter without professional supervision to

layman. Essentially the FDA is delegating

the veterinarian to the role of an animal

undertaker for the veterinarian will be able

to do little with approved drugs for approved

uses except watch the animal die.

The FDA has issued a policy guide relating to

unapproved uses of approved new animal drugs.

The FDA has made it clear that such unap-

oroved use of approved drugs is to occur only

in rare circumstances and it will be within

FDA's discretion whether to prosecute the vet-

erinarian. This point is missed by the

Seventh Circuit. In its opinion the Seventh

Circuit states, "If the need is great and the

risk is small, the FDA will not contend that

re-mixing approved drugs, or using them in a

way other than per directions on the label,

causes their ‘adulteration’ under the acts".

The Seventh Circuit cites no authority for

this statenent nor does it provide veterin-

aha

peciareanate Bod 4 18

arians guidance as to when the “need is

great" or the "risk is small". In essence

the FDA and the Seventh Circuit Court of

Appeals want the veterinarian to choose on a

daily basis whether to be a criminal and

properly treat an animal or to ignore ha wbae

fessional duty of the veterinarian and allow

an animal to suffer and die when known, effec-

tive treatments are available though unap-

proved by the FDA.

Given the fact that the number of approved

drugs used in approved manners are extremely

limited in food aninals and the FDA and the

Seventh Circuit have decided that bulk chem-

icals should not be made available to vet-

2erinarians to compound their own medications,

the only class of drugs left out of which the

veterinarian may treat animals are _ those

drugs which were "grandfathered" under the

Act so as to not need approval. While both

the FDA and the Seventh Circuit speak as if

=the

memes Wil

this were a major class of drugs, the truth

is that the class is non-existent. In its

Opinion the Seventh Circuit spent a fair

amount of time analyzing the words, "lawfully

acquired". The conclusion of that court was

that the only drugs which would meet the

requirements of these words were approved

drugs used in approved manners and "“grand-

fathered" drugs. Since the requirement to

use only approved drugs in approved manners

is in essence the issue of this case, it is

only the “grandfathered” drugs which are in

fact part of the reasoning of the Seventh

Circuit. That reasoning is faulty simply

because the grandfathered drugs are a non-

existent class. The court does note that

veterinarians could not use drugs which they |

have stolen; however, state and federal |

criminal laws seem a more appropriate means

of deterring the theft of drugs rather than

using the seizure provisions under the Act.

The analysis of the Seventh Circuit simply

makes no sense when one looks closely at the

results of that analysis.

‘In a deposition in the Algon case, Dr. Gerald

B. Guest, the Director for the Center of

Veterinary Medicine of FDA could not think of

a single example of such grandfathered drugs.

Aee at 00045. Further, Dr.- Andrew Beaulieu a

Director of the FDA gave as examples of grand-

fathered drugs common table salt and epsom

salt. Supplemental Appellant Appendix in the

Seventh Circuit at 21. Are veterinarians to

be relegated to administering salt solutions

to pork to advance the curing process prior

to slaughter and giving epsom salt foot baths

to milk cows who have stood too long? While

the examples are silly, they are no sillier

than the positions put forward by the FDA and

the Seventh Perouit regarding grandfathered

drugs. Surely, Congress did not mean that

veterinarians may lawfully purchase only

-38-

approved drugs for use in approved manners |

(and if so the exenption would not be needed)

or useless items which would not provide

relief to the health problems from which the

patients are suffering.

H. Implementation of the Seventh Circuit's

Opinion by the FDA will have catastrophic

effects for the American public. If the FDA

is allowed to extend its authority over vet-

erinarians by prohibiting veterinarians from

obtaining the bulk chemicals to compound

their prescriptions, the FDA will achieve

important control over the activities of the

veterinarian. Further, they will restrict

veterinarian in his practice and inhibit the

professional relationship between the veterin- |

arian and his patient. The result will be |

Simple. In uncertain situations veterin-

arians will not act except with the prior

approval of the FDA which as the veterin-

arians attest will not come in a timely

-39-

manner. Aee at 00020-00042. Food animals

will die and their capacities to produce food

will be diminished. There will be unneces-

sary suffering among- the food animals, there

will be severe adverse effects within the

agricultural economy, and the American

consumer will be hurt by diminished supplies

and increased prices. It is a simple fact of

life that the FDA will not be able to react

to the ever changing prescription needs of

the food animals. Only the on-site veter-

inarian using his experience, education, and

professional insight will be able to react to

the immediate health demands of the herds and

flocks of the food animals.

When a veterinarian compounds a drug (whether.

from pure chemicals or non-approved extra-

label use of approved drugs), it is to treat

a present problem. There is no time to get

FDA approvals. Bacteria change and treatment

needs change. The Seventh Circuit's opinion

-4 O-

fails to realize that the uncontradicted fact

is that there is a continuing, on-going need

for immediate action by the veterinarian to

respond to the ever changing disease pro-

ducing organisms. Drug houses which produce

products to be used by the uneducated layman

must do long, ongoing tests to make certain

that their products are safe and effective

for the use by the layman on a mass level.

The veterinarian, on the other hand, is

compounding his prescriptions for use in a

particular instance against a particular

disease organism. Even if the veterinarian

could go through the FDA approval process,

the approval would be meaningless since the

particular problem for which the veterinarian

needed the prescription would be over (and

perhaps the herd wiped out).

Why should there be any variation from the

past relationship between the veterinarian

and the FDA? It cannot be because we are

mf Des

dissatisfied with the quality or the quantity

of meat, milk, and eggs. Further, control by

the FDA over the veterinarian is not mandated

by statute. At best the FDA is attempting to

stretch the statute, enhance its authority,

and control the veterinarian as has not done

before. While we believe the law is clear

that such a power grab is not allowed by the

Act, it certainly cannot be said that the FDA

has asserted this type of control previously

over the veterinarian. The best the FDA can

argue is that this is simply a power it has

had over the last 50 years or since 1968 (the

time of the passage of the Animal Drug Amend-

ments) but has not asserted. This would

certainly seem strange.

The law requires and policy dictates that the

FDA not be allowed to inhibit the veterin-

arian from acquiring the bulk chemicals which

he needs to compound his prescriptions. The

future of the food supply is best served by

-42-

continuing the progress which has occurred

over the last 50 years and not by placing the

FDA in a position of dominance over. the

veterinarian.

V. CONCLUSION

A review of the Act, a review of the FDA's

regulations, and a review of the intent of

Congress shows a consistent approach since

1938. That consistent approach is to re-

gulate the use of drugs in food animals by

agencies of the federal government with an

exemption for the licensed veterinarian to

practice his healing arts. The intent of

Congress, the policies embedded in the

Statutory provisions, and the policies car-

ried on by the FDA for 50 years have been to

place trust and confidence in the hands of

veterinarians when they use drugs inthe

treatment of food animals. The implementa-

tion of the Seventh Circuit's opinion will

Subvert the intent of Congress, misapply the

=~43-

law, and grant to the FDA authority which it

would not have but for the misapplication of

the law.

Veterinarians are very concerned. If the FDA

succeeds, it will in effect control what

veterinarians may prescribe by controlling

what chemicals are available. The law re-

peatedly provides exemptions for veterinar-

ians, and the FDA in its enforcement of the

law has not previously taken a position such

as the one it has in this case. Because it

is bulk chemicals which were seized by the

FDA, they meet the requirements of the

Statute and regulations as to labeling and

are not new animal drugs. Further, it is

ludicrous for the FDA to even imply that

Schuyler should instruct veterinarians how to

use the chemicals. The veterinarians are

knowledgable as to the use of these chemi-

cals, much more so than Schuyler or the FDA.

Based upon the Constitution, the Act, the

-44-

regulations, the past history and conduct of

the FDA, and the policy for the future, this

Court should grant the Writ of Certiorari of

Petitioners in order to avoid a food animal

health catastrophe.

Respectfully submitted,

LE FEVRE, ZEMAN, OLDFIELD & SCHWARM

LAW GROUP, LTD., Attorney for AMERICAN

FOOD ANIMAL VETERINARY ASSOCIATION

ila Cldbl

David A. Oldfield,/ZEsq.

LeFevre, Zeman, Oldfield & Schwarm

Law Group, Ltd.

303 S. Seventn Street, P.O. Box 399

Vandalia, IL 62471

618/283-3034

File #5137/8301-4

-45-