# 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 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385002_0261%3A4 ## Record - **Collection:** Supreme Court brief - **Document type:** Amicus Curiae Brief - **Published:** January 1, 1989 - **Citation:** 489 U.S. 1010 ## Text 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