Opinion and order granting summary judgment re growth promoter antibiotics

8/2/2019 Opinion and order granting summary judgment re growth promoter antibiotics

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UNITED STATES DISTRICT COURTSOUTHERN DISTRICT OF NEW YORK- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - XNATURAL RESOURCES DEFENSE COUNCIL,INC., e t a l . ,

P l a i n t i f f s ,-aga ins t -

UNITED STATES FOOD AND DRUGADMINISTRATION, e t a l . ,

Defendants .----------------------------------------xTHEODORE H. KATZ, UNITED STATES MAGISTRATE JUDGE.

P l a i n t i f f s Natura l Resources Defense Council , Inc . ("NRDC"),Center fo r Science in the Publ ic In t e re s t , Food Animal ConcernsTrus t , Publ ic Ci t izen , and Union of Concerned Sc i en t i s t s , Inc.(co l lec t ive ly "P l a i n t i f f s " ) br ing t h i s ac t ion aga ins t the UnitedSta tes Food and Drug Adminis t ra t ion ("FDA"), Margaret Hamburg, inher o f f i c i a l capac i ty as Commissioner of the FDA, the Center fo rVeter inary Medicine ("CVM"), Bernadet te Dunham, in her o f f i c i a lcapaci ty as Direc to r of the CVM, United Sta tes Department of Healthand Human Services ("HHS"), and Kathleen Sebel ius , in her o f f i c i a lcapaci ty as Secretary of HHS, a l l eg ing t ha t the FDA withheld agencyact ion i n v io l a t i on of the Food, Drug, and Cosmetic Act ("FDCA"),21 U.S.C. 360b(e) (1) , and the Adminis t ra t ive Procedure Act("APA"), 5 U.S.C. 706(1) . The par t i e s have consented to t r i a l

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11 civ . 3562(THK)

MEMORANDUMOPINION AND ORDER

Case 1:11-cv-03562-THK Document 70 Filed 03/22/12 Page 1 of 55


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before th i s Court , pursuant to 28 U. S . C. before the are the par t c r o s s - m o t ~ : fo r summaryourt s

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judgment. For the reasons t ha t fol low, motion i sgranted and Defendants ' motion i s denied.

BACKGROUND1

I . OverviewFor over t h i r t y years , the FDA has taken the s i t ion t ha t the

widespread use of ce r t a i n an t i b i o t i c s in l ives fo r purposeso ther than disease t r ea tment poses a t h rea t to hea l th . In 1977, the FDA issued not ices announcing i t s i n ~ ~ n t to withdraw approval of the use of cer ta in an t i b i o t i c s in I ~ v e s t o c k fo r the purposes of growth promotion and feed e f f ic iency , I Which the agencyhad found had not been proven to be sa fe . The: FDA issued theno t ices pursuant to 21 U.S.C. 360b(e) (1) , w h i c ~ s t a t e s t ha t

[ t ]he Secre tary sha l l , a f t e r due not ice and oppor tuni tyfo r hear ing to the appl icant , i ssue an order withdrawingapproval of an app l i ca t ion ... with respec Jto any newanimal drug i f the Secretary f inds . (i8) t ha t newevidence not contained in such appl ica t1pn or notava i l ab le to the Secretary un t i l a f t e r suchi .ppl ica t ionwas approved, o r t e s t s by new methods, t e s t s bymethods not deemed reasonably appl icable iwhen suchappl ica t ion was approved, evaluated togeth t: with theevidence avai lab le to the Secre tary when the 4ppl ica t ion, !

1 Except where otherwise noted, the fol lowing fac t s , der ivedfrom the par t i e s ' Statements Pursuant to Local CIVil Rule 56.1,are undisputed.

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was approved, shows t ha t such drug i s not ishown to besafe fo r use under the condi t ions of use up6n the bas i sof which the app l i ca t ion was approved .

21 U.S.C. 360b(e) (1) (B). Although the not icFs were proper lyIIpromulgated and over twenty drug sponsors reques ted hear ings on themat te r , the FDA never held hear ings o r took any fu r the r ac t ion onthe proposed withdrawals .

In the in tervening years , th e s c i e n t i f i c eVi4ence of the r i sksto human heal th from the widespread use of an t i b i o t i c s in l ives tockhas grown, and the re i s no evidence t ha t the F D ~ has changed i t spos i t ion t ha t such uses are not shown to be sa fe . In May 2011,a f t e r the FDA fa i led to respond to two Ci t izen P e t ~ t i o n s urging theagency to fol low through with the 1977 n o t i c e s , P l a i n t i f f s f i l edt h i s act ion seeking a cour t o rder compel l ing the FDA to completeth e withdrawal proceedings fo r an t i b i o t i c s included in th e 1977not ices . In December 2011, the FDA withdrew the or ig ina l no t iceson the grounds t ha t they were outda ted , and it now argues t ha tP l a i n t i f f s ' cla im i s moot.I I . Use of Ant ib io t i c s in Food-Producing Animals

Ant ib io t i c s , a l so known as ant imicrobia ls , 4re drugs used tot r e a t i n fec t ions caused by bac te r ia . Al though ' an t ib io t ic s havesaved count less l ives , the improper use and overuse of an t i b i o t i c shas led to a phenomenon known as an t i b i o t i c res i s t ance .

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Spec i f i ca l ly , the misuse of an t i b i o t i c s crea tes se lec t iveevolut ionary pressure t ha t enables an t ib io t i c r e s i s t an t bac te r ia toincrease in numbers more rap id ly than an t ib io t i c suscep t ib lebac te r ia , increas ing the oppor tuni ty fo r ind iv idua l s to becomein fec ted by r e s i s t a n t bac te r ia . People who con t rac t an t i b i o t i c -r e s i s t an t bac t e r i a l in fec t ions are more l i ke l y to have longerhosp i t a l s tays , may be t r ea ted with l e s s e f fec t i ve and more toxicdrugs, and may be more l ike ly to d ie as a r e su l t of the in fec t ion .The FDA cons iders an t ib io t i c re s i s tance "a mounting publ ic heal thproblem of global s ign i f i cance . " (F i r s t Amended Complaint ( "F i r s tAm. Compl.") 38 i Answer 38.)

In the 1950s, the FDA approved the use of an t i b i o t i c s tos t imula te growth and improve feed e f f ic iency in food-producinganimals , such as ca t t l e , swine, and chickens . Ant ib io t i c s used fo rgrowth promotion are typ ica l ly administered through animal feed o rwater on a herd- or f lock-wide bas i s . The approved doses ofant ib io t i cs fo r growth promotion are typ ica l ly lower than theapproved doses fo r disease t rea tment . The adminis t ra t ion of"medical ly important II 2 an t i b i o t i c s to en t i r e herds o r f locks of

2 The term "medical ly important ant ib io t i cs" re fe r s toant ib io t i c drugs t ha t are important for therapeut ic use inhumans.

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food-producing animals , a t "subtherapeutic, ,3 l eve l s , poses aqual i t a t ive ly higher r i sk to publ ic hea l th than the admin is t r a t ionof such drugs to ind iv idua l animals o r ta rge ted groups of animalsto prevent o r t r e a t s pe c i f i c d i seases . (See Answer 3 4 . )Research has shown t ha t the use of an t i b i o t i c s in l i ves tock leadsto the development of an t ib io t i c - r e s i s t an t ba c t e r i a t ha t can beand has been - t r ans fe r red from animals to humans through d i rec tcontact , environmental exposure, and the consumption and handl ingof contaminated meat and poul t ry produc ts . Consequently, the FDAhas concluded t ha t "the overa l l weight of evidence ava i l ab le todate supports the conclusion t ha t us ing medical ly importantan t imicrob ia l drugs fo r product ion purposes [ in l ives tock] i s notin the i n t e r e s t of pro tec t ing and promoting the publ ic heal th ."(Guidance No. 209, at tached as Exhibi t B ("Ex. B") to Declara t ionof Ass i s t an t uni ted Sta tes Attorney Amy A. Barcelo ("BarceloDec1. ) a t 13.}II I I . Penic i l l in and Tetracycl ines

The presen t ac t ion pe r t a ins to the use of th ree d i f f e r e n t

3 The term "subtherapeut ic ll was commonly used in th e 1960sand 1970s to r e f e r to any use of an t i b i o t i c s fo r purposes o therthan disease t rea tment and prevent ion , inc luding growth promotionand feed ef f i c i ency in animals . Although FDA no longer uses theterm, in t h i s Opinion the Court uses th e term "subtherapeut ic ll tor e fe r to the use of an t i b i o t i c s i n food-producing animals fo rgrowth promotion and feed ef f i c i ency .

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an t i b i o t i c s in animal feed: pen ic i l l i n and tw o forms oft e t r acyc l i ne chlor t e t racyc l ine and oxy te t racyc l ine(" te t racycl ines") . Pursuant to the FDCA, any "new animal drug" 4t ha t i s introduced in to i n t e r s t a t e commerce must be the sub jec t ofan FDA approved new animal drug appl ica t ion ("NADA") or, withrespect to gener ic drugs, an abbrevia ted NADA ("ANADA"). See 21U.S.C. 360b(b)- (c) . Drug companies t ha t submit NADAs/ANADAs aretyp ica l ly re fe r red to as "appl icants" o r "sponsors ." The FDAlawfully issued NADAs and ANADAs fo r pen ic i l l i n and t e t r acyc l inesin the mid 1950s. Since t ha t t ime, pen ic i l l i n has been used topromote growth in chickens turkeys and swine and t e t r acyc l inesI lhave been used to promote growth in chickens , turkey, swinec a t t l e l and sheep.

In the mid 1960s 1 the FDA became concerned t ha t the long-termuse of an t i b i o t i c s , inc luding pen ic i l l i n and t e t r acyc l ines infood-producing animals might pose th rea t s to human and animalheal th . As a r e su l t in 1970, the agency convened a task force tos tudy the r i sks associa ted with the use of an t ib io t i c s in animalfeed. The task force was composed of sc ien t i s t s from the FDA, theNational In s t i t u t e s of Heal th , the U.S. Department of Agricul ture ,

4 A new animal drug i s def ined, i n pa r t as "any drugin tended fo r use fo r animals other than man, inc luding any drugin tended fo r use in animal feed but not inc luding such animalf e e d . See 21 U.S.C. 321(v) .'6



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the Center fo r Disease Control , as well as rep resen ta t ives fromun ive r s i t i e s and indus t ry . In 1972, the task force publ i shed i t sf indings , concluding tha t : (1) the use o f an t i b i o t i c s in animalfeed, espec ia l ly a t doses lower than those necessary to prevent o rt r e a t disease , favors the development of an t ib io t i c - r e s i s t an tbac te r i a ; (2 ) animals receiv ing an t i b i o t i c s i n t h e i r feed may serveas a rese rvo i r of an t i b i o t i c pathogens, which can produce humani n fec t ions ; (3) the prevalence of bac te r ia carry ing t r ans fe r rab ler e s i s t an t genes fo r mult ip le an t i b i o t i c s had increased in animals ,and the increase was re la ted to the use of an t i b i o t i c s ; (4 )an t ib io t i c - r e s i s t an t bac te r ia had been found on meat and meatproducts ; and (5) the prevalence of an t i b i o t i c r e s i s t a n t bac te r iain humans had inc reased. See Ant ib io t ic and Sulfonamide Drugs inAnimal Feeds, 37 Fed. Reg. 2,444, 2,444-45 (Feb. I , 1972). Thetask fo rce made severa l recommendations, inc luding t ha t (1)an t i b i o t i c s used in human medicine be prohib i ted from use in animalfeed unless they met safe ty c r i t e r i a es tab l i shed by th e FDA, and(2) severa l spec i f ic drugs, inc luding pen ic i l l i n and t e t racyc l ines ,be reserved fo r the rapeu t ic use unless they met sa fe ty c r i t e r i a fo rnon- therapeut ic use. See

In response to the f indings of th e t ask force , th e FDA, in1973, i s sued a regula t ion provid ing t ha t the agency would proposeto withdraw approval of a l l subtherapeut ic uses of an t i b i o t i c s in

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animal feed unless drug sponsors and othe r in te res ted par t iessubmi t t ed data wi th in the next tw o years "which resolve[d]conclusive the i ssues concerning [ the drugs ' ] safe ty to man andanimals . . under spec i f ic c r i t e r ia" es tab l i shed by the FDA.Ant ib io t i c and Sulfonamide Drugs in the Feed of Animals, 38 Fed.Reg. 9 ,8 1 1 , 9 ,813 (Apr. 20, 1973) (codif ied a t former 21 C.F.R. 135 . 109 i renumbered a t 21 C.F.R. 5 5 8 . 1 5 ) . One of th e mostimportant of the human and animal hea l th safe ty c r i t e r i a t ha t theFDA es tab l i shed fo r drug sa fe ty evalua t ions under the regula t ioninvolved the t r ans fe r of an t ib io t ic r e s i s t a n t bac te r ia from animalsto humans. The FDA regula t ion requi red t ha t "[a]n an t ibac te r ia ldrug fed a t subtherapeut ic l eve l s to animals must be shown not topromote increased r es i s tance to an t ibac te r ia l s used in humanmedicine. II Penic i l l in-Conta ining Premixes Notice ( "Pen ic i l l inNotice") , 42 Fed. Reg. 4 3 , 7 7 2 , 43 ,774 (Aug. 3D, 1 9 7 7 ) . The othe rhea l th safe ty c r i t e r i a involved showing tha t use of an t ib io t icswould not increase salmonel la in animals , would not increase thepathogenic i ty of bac te r ia , and would not increase res idues in foodingested by man, which may cause " increased numbers of pathogenicbac te r ia or an increase in the r es i s tence of pathogens toan t ibac te r i a l agents used in human medicine. II See id .

Over the next two years , the Bureau of Veter inary Medicine

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(\\BVM") ,5 a subdivis ion of the FDA, reviewed the da ta submit ted bydrug sponsors to support the subtherapeut ic use of an t i b i o t i c s . ByApr i l 20, 1975, a l l data concerning the safe ty and ef f i cacyc r i t e r i a fo r an t i b i o t i c drugs had been received .

The BVM was ass i s t ed by a sUb-committee of the FDA'sNational Advisory Food and Drug Committee ("NAFDC") in i t s reviewof the da ta . The NAFDC sUb-committee i s sued a repor t andrecommendations on the subtherapeut ic use of pen ic i l l i n in animal

feed, which the NAFDC adopted in 1977. The NAFDC"recommended t ha t FDA immediately withdraw approval fo r thesubtherapeut ic uses of pen i c i l l i n , i . e . , growth promotion/feedef f i c i ency , and disease con t ro l . " rd . Simi la r ly , the NAFDC subcommittee made cer ta in recommendations regarding the use oft e t racyc l ines in animal feed. Spec i f ica l ly , fo r t e t racyc l ines , thesub-committee recommended t ha t the FDA "(1) discont inue t h e i r usefo r growth promotion and/or feed e f f ic iency in a l l animal speciesfo r which e f f e c t ive subs t i tu tes a re ava i l ab le , (2 ) permi t t h e i r usefo r d isease cont ro l where e f f e c t ive a l t e rna t e drugs are unavai lable

. , and (3 ) con t ro l the d i s t r i bu t i on of the t e t racyc l inesthrough a ve te r ina r ian 'S order to r e s t r i c t t h e i r use."Tetracycl ine (Chlor te t racycl ine and Oxyte t racyc l ine) -Conta ining

5 The BVM was renamed the Center fo r ve te r ina ry Medicine (\\CVM") in 1984.

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Premises; Opportunity fo r Hearing ("Tetracycline Not ice") , 42 Fed.Reg. 56,264, 56,266 (Oct. 21, 1977). The NAFDC re jec ted the f i r s ttwo recommendations, but adopted the t h i rd recommendation. id .IV. The 1977 NOOHs

Afte r ca re fu l ly cons ider ing the recommendations of the NAFDCand the NAFDC sub-committee, the Director of the BVM i s sued not icesof an oppor tuni ty fo r hear ing ("NOOHs") on proposa ls to withdrawapproval of a l l subtherapeut ic uses of pen ic i l l i n in animal feed,

see Penic i l l in Notice, 42 Fed. Reg. a t 43,772, and, with l imi tedexcept ions, a l l subtherapeut ic uses of oxyte t racycl ine andchlor te t racyc l ine in animal feed, see Tet racyc l ine Notice, 42 Fed.Reg. a t 56,264. In the Pen i c i l l i n Notice, the Director repor tedtha t "[n] one of the spec i f i ed human and animal hea l th sa fe tyc r i t e r i a [for the subtherapeut ic use of an t i b i o t i c s in animal feed]have been sa t i s f i ed . " Pen i c i l l i n Notice, 42 Fed. Reg. a t43,775. With r espec t to the t r ans fe r of an t ib io t i c r e s i s t an tbac te r ia , the Director surveyed the ava i l ab le data and found t ha t(1) the pool of bac te r ia car ry ing t r ans fe r rab le re s i s tance geneswas increas ing; (2) the increase was due i n pa r t to thesubtherapeut ic use of pen ic i l l i n in animal feed; and (3)an t ib io t i c - r e s i s t an t bac te r ia were t r ans fe r red from animals tohumans as a r e su l t of d i rec t human-animal contac t , the consumptionof contaminated food, and the widespread presence of r e s i s t an t

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bac te r ia in the environment. See id . a t 43,781. Studies submit tedby pen i c i l l i n app l ican t s and sponsors had f a i l ed to rebut thesesf indings . See Based on t h i s evidence , th e Direc to r of th e BVMproposed to withdraw approval of a l l NADAs!ANADAs fo r the use ofpeni l l i n in animal feed on the grounds " t h a t the [se] drug

/Iproducts are not shown to be sa fe . rd . a t 43,792. TheDirector fu r t h e r caut ioned t ha t " [ t ]he evidence , in fac t , i nd ica tes

/It ha t such pen ic i l l i n use may be unsafeSimi la r ly , the Direc to r of the BVM announced heal th and sa fe ty

concerns regard ing the subtherapeut ic use of t e t racyc l ines inanimal feed. The Direc to r expla ined t ha t " [e]vidence demonstra test ha t the use of subtherapeut ic l eve l s of the t e t racyc l ines . . . inanimal feed con t r ibu tes to the increase in an t i b i o t i c r e s i s t an tColi and in the subsequent t r ans fe r of t h i s res i s t ance toSalmonella . Further! some s t r a i ns o f Col i and Salmonella i n f e c tboth man and animals . Thus! the po te n t i a l fo r harm ex i s t s .

'I Tetracycl ine Notice! 42 Fed. Reg. a t 56,267. The Directoralso noted t ha t , in response to the 1972 FDA regula t ion announcingthe hea l th sa fe ty c r i t e r i a fo r use of an t i b i o t i c s in animal feedth e s tud ies submit ted by the holders of t e t r a c yc l ine s NADAs!ANADAs"were inconc lus ive because the s tud ies were inappropriate . /1 rd .The Director concluded t ha t he " is unaware of evidence t ha ts a t i s f i e s the requirements fo r demonstrat ing the sa fe ty of

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II

extens ive use of subtherapeut ic t e t racyc l ine -con ta in ing premixesId . a t 56,288. Based on t h i s evidence, the Di rec to r

proposed to withdraw approval of cer ta in NADAs/ANADAS fo r thesubtherapeut ic use of t e t racyc l ines "on the grounds t ha t they have

IInot been show to be sa fe .In response to the 1977 NOOHS, approximately twenty drug

firms, agr i cu l t u ra l organ iza t ions , and ind iv iduals requestedhear ings . Pen i c i l l i n and Tetracycl ine in Animal Feeds Hearing,43 Fed. Reg. 53,827, 53,828 (Nov. 17, 1978). On November 9, 1978,the Commissioner of the FDA granted the reques ts for hear ings ,s t a t i ng t ha t " there w[ould] be a formal ev iden t i a ry publ ic hear ingon [ the proposed withdrawals] " a t 53,827. The Commissioners ta ted t ha t a date fo r the hear ing would be se t "as soon asprac t icable . " Id . a t 53,827-28. According to the s ta tu tory andregula tory scheme, a t the hear ing, the drug sponsors would have theburden of proving t ha t the drugs were in fac t sa fe . (See FDA,Fina l Decis ion of the Commissioner, Withdrawal of Approval of theNew Animal Drug Appl ica t ion fo r Enrofloxacin in Poultry("Enrofloxacin Decis ion" ) , at tached as Ex. N to Barcelo Decl. a t 89. )V. The FDA's Actions Following the Issuance of the 1977 NOOHs

The Commissioner never se t a date fo r the hear ings on theBVM's proposal to withdraw approval of the use of pen ic i l l i n and

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t e t racyc l ines in animal feed. In the l a te 1970s and ea r ly 1980s,Congressional committees i s sued three repor t s t ha t containedsta tements t ha t the FDA in te rpre ted as reques ts to postpone thewithdrawal hear ings pending fur the r research . Spec i f ica l ly , in1978, the House Committee on Appropr ia t ions "recommend[ed]1f t ha tthe FDA conduct research regarding "whether o r not the cont inuedsubtherapeut ic use of [penic i l l in and t e t racyc l ines ] would r e su l tin any s i gn i f i can t human hea l th r i sk" before revoking suchapproval . H.R. Rep. No. 95 1290, a t 99 100 (1978) . In 1980, theHouse Committee on Appropr ia t ions requested tha t the FDA "hold inabeyance any implementation" of the proposed revocation pendingfu r the r research . H.R. Rep. No. 96 1095, a t 105-06 (1980) . In1981, the Senate Committee on Appropr ia t ions made a s imi la rreques t . See S. Rep. No. 97-248, a t 79 (1981) . Important ly, noneof these recommendations was adopted by the fu l l House or Senate,and none was passed as law.

Regardless of the l ega l e f f ec t of these Congressionals ta tements , the FDA never held hear ings on the proposedwithdrawals , and ins tead engaged in fur the r research on the r i sksassocia ted with the subtherapeut ic use of an t ib io t i c s in food-producing animals . Soon a f t e r the i n i t i a l House Appropr ia t ionsCommittee reques t , the FDA cont rac ted with the National Academy ofSciences ("NAS") to assess the human heal th consequences of the

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causes a po ten t i a l human hea l th hazard. II Excerpt fromIn s t i t u t e of Medicine 1988 Report , a t tached as Ex. H to SorensonDecl. a t 194. )

After the publ i ca t ion of the Seat t le -King County and theIn s t i t u t e of Medicine s tud ies , the FDA took little ac t ion on thes t i l l - pend ing 1977 NOOHs. In 1983, the Commissioner deniedrequests from seve ra l drug sponsors to resc ind the 1977 NOOHs. SeePen ic i l l i n and Tetracycl ine in Animal Feeds, 48 Fed. Reg. 4,554,4, 556 (Feb. 1, 1983) . The Commissioner expla ined t ha t the 1977NOOHs "represent [ed] the Dir ec to r ' s formal pos i t ion t ha t use of thedrugs i s not shown to be safe" and t ha t the Commissioner"concur [red] If with the dec i s ion of the Direc tor . Id . In 2003, theFDA publ i shed a proposed ru le tha t referenced the r i sks to humanheal th from the subtherapeut ic use of an t ib io t i c s in animal feed.

New Animal Drugs; Removal of Obsole te and RedundantRegulat ions , 68 Fed. Reg. 47 ,272 , 47,272 (Aug. 8, 2003) . The FDAreferenced the NAS and I n s t i t u t e of Medicine r epor t s , as wel l othe rr e levan t s tud ies . The FDA "( 1 ) [c] onc 1udedt ha t the r i sks were ne i the r proved nor disproved, (2 ) d id not denythere was some degree of r i sk , and (3) d id not conclude t ha t thecont inued subtherapeut ic use of peni l l i n and t e t r acyc l i nes inanimal feed i s sa fe . 1I In 2004, the BVM, now known as theCenter of Veter inary Medicine ("CVM If ), sen t l e t t e r s to severa l

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manufacturers of approved animal feed products conta in ingpen ic i l l i n and t e t racyc l ines , expla in ing t h a t " [t] he adminis t ra t iverecord does not conta in su f f i c i en t in format ion to a l l ev i a t e theCVM's concerns about the use of [ these] produc t [s] and [ thei r ]poss ib le role in the emergence and disseminat ion of an t imicrob ia lres is tance ." (FDA Let t e rs to Drug Sponsors (2004), at tached as Ex.N to Sorenson Decl. a t 2.) The FDA inv i ted manufacturers to meetwith the agency to discuss the agency ' s f indings .

On June 28, 2010, the FDA re leased a non-binding Draf tGuidance en t i t l ed The JUdicious Use of Medical ly ImportantAntimicrobial Drugs in Food-Producing Animals ("2010 Draf tGuidance") . (See Guidance No. 209, a t tached as Ex. B to BarceloDecl. a t 1.) In the Draf t Guidance, the FDA reviewed recentsc i en t i f i c s tud ies on the r i s ks posed by the subtherapeut ic use ofant ib io t i cs in animal feed, including a 1997 World Heal thOrganizat ion exper t committee repor t t ha t "recommended tha t the useof an t imicrob ia l drugs fo r growth promotion in animals beterminated i f these drugs are also presc r ibed fo r use as an t iin fec t ive agents in human medicine o r i f they are known to inducecross - res i s t ance to an t imicrob ia l s used fo r human medical therapy."(See a t 8.) After reviewing the sc i en t i f i c evidence, the FDAconcluded t ha t "the overa l l weight of evidence ava i l ab le to datesupports the conclus ion t ha t using medical ly important

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ant imicrobia l drugs fo r produc t ion purposes i s no t in the i n t e r e s tof protec t ing and promoting the publ ic hea l th . " ( Id. a t 13.) TheFDA announced two non-mandatory pr inc ip les to guide the use ofan t i b i o t i c s in animal feed: (1) " [ t l he use of medica l ly importantan t imic rob ia l drugs in food-producing animals should be l imi ted tothose uses t ha t are cons idered necessary for assur ing animalhea l th[ ; ] " and (2) " [ t ]he use of medica l ly impor tant an t imicrob ia ldrugs in food producing animals should be l imi ted to those usest ha t include ve te r ina ry overs igh t or consu l t a t ion . " (Id. a t 1617. )

On December 16, 2011, near ly twenty-f ive years a f t e r t h e i ri n i t i a l pub l ica t ion and during the pendency o f t h i s ac t ion , the FDAresc inded the 1977 NOOHs. Withdrawal of Notices of Opportuni tyfo r a Hearing; Penic i l l in and Tetracycl ine Used in Animal Feed("NOOH Withdrawals") , 76 Fed. Reg. 79,697, 79,697 (Dec. 22, 2011).The FDA exp la ined t ha t it was resc inding the NOOHs because the "FDAi s engaging in o th e r ongoing r egu la to ry s t r a t eg i e s developed s incethe pub l ica t ion of the 1977 NOOHs" and t ha t i f th e FDA were to moveforward with the NOOHs it would need to "update th e NOOHs tor e f l e c t cur ren t data , in fo rmat ion , and pol ies" and "p r i o r i t i zeany withdrawal proceedings . 1t Id . The FDA noted t ha t "al though[ i t ] i s withdrawing the 1977 NOOHs, FDA remains concerned about thei s sue of an t imicrob ia l re s i s tance ." The FDA

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explained t ha t the withdrawal of the NOOHs "should not bei n t e rp r e t e d as a s ign t ha t FDA no longer has sa fe ty concerns o rtha t FDA wi l l not cons ider re -propos ing withdrawal proceedings inthe fu tu re , i f necessary ." rd . a t 79,698.VI. The Presen t Action

Pla in t i f f s f i the presen t ac t ion on May 25, 2011, al leg ingt ha t the FDA's fa i to withdraw approval of the subtherapeut icuse of pen ic i l l i n and t e t racyc l ines pursuan t to the 1977 NOOHscons t i tu t ed an agency ac t ion unlawful ly withheld or unreasonablydelayed i n v io l a t i on of the APA, 5 U.S.C. 706(1) , and the FDCA,21 U.S.C. 360b{e) (1).6 Pla in t i f f s seek a Court order compell ing

6 The Fi r s t Amended Complaint conta ined an add i t iona l claimperta in ing to tw o Ci t izen Pe t i t ions submit ted by Pla in t i f f s tothe FDA in 1999 and 2005. F i r s t Amended Compl. " 99-101.)In those Ci t izen Pe t i t i ons , P l a i n t i f f s pe t i t ioned th e FDA toimmediately withdraw approval fo r cer ta in uses of pen ic i l l i n andt e t racyc l ines in l i ves tock given the evidence o f the r i sks posedto human hea l th . (See " 82 87.) The FDA never i s sued af i na l response to these p e t ions . On November 7, 2011, the FDAi s sued f i na l responses to both Cit izen Pe t i t i ons , denying thereques ted act ion . (See St ipula t ion and Order, dated Jan. 6,2012). Consequently, Pla in t i f f s withdrew t h e i r claim as to th eCi t izen Pe t i t ions as moot, and the Court dismissed the claimwithout pre jud ice . ) On January 9, 2012, Pla in t i f f sf i l ed a motion fo r leave to f i l e a supplemental complaint , whichthe Court gran ted on January 31, 2012. (See Scheduling Order,dated Jan. 31, 2012.) P l a i n t i f f s f i l e d t h e i r SupplementalComplaint on February 1, 2012, which added a claim t ha t the FDA'sf responses to the 1999 and 2005 Cit izen Pe t i t i ons were"a rb i t ra ry , capr ic ious , an abuse of disc re t ion , o r otherwise notin accordance with law, i n v io l a t i on of the [FDCA], 21 U.S.C. 360b, and the APA, 5 U.S.C. 706(2) ." (Supplemental CompI. ,38. )

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the FDA to withdraw approval fo r the subtherapeut ic use ofpen ic i l l i n and t e t racyc l ines in animal feed[ unless [ a f t e r ahearing[ the drug uses a t i s sue are determined to be sa fe .Amended CompI. lOl(C) .) Pla in t i f f s fur the r reques t t ha t theCourt se t a deadl ine by which the FDA must hold hear ings and i ssuea f i na l decis ion on the withdrawals . id . ) Pla in t i f f smaintain t ha t under the FDCA[7 21 U.S.C. 360b(e) (1), once the FDAfound t ha t the subtherapeut ic use of pen ic i l l i n and t e t racyc l inesin animal feed was not shown to be safe to humans, th e agency wass t a tu to r i l y obl igated to withdraw approval of those uses[ unlessthe drug sponsors demonstra ted the sa fe ty of the drugs . Defendantscontend t ha t withdrawal was not l ega l ly required[ and t in anyevent , the issue i s now moot because the 1977 NOOHs have beenwithdrawn. Pla in t i f f s r ep ly t ha t the recen t withdrawal of theNOOHs was in response to th i s l i t i g a t i o n and has no bear ing on theFDA's obl igat ion to ac t .

DISCUSSIONI . Legal Standard

A. Summary JudgmentA motion fo r summary judgment may not be granted unless the

Court determines t ha t the re i s no genuine sue of mater ia l fac t to

7 within the i n t e rna l numbering of the FDCA, the s t a tu t e a ti s sue in th i s case 512.

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be t r i ed , and t ha t the fac t s as to which the re i s no such i s suewarrant judgment fo r the moving par ty as a mat te r of law.Celotex Corp. v. C a t re t t , 47 7 U.S. 317, 322-23, 106 S. C t. 2548,2552-53 (1986) i Pa t t e r son v . Cnty. of Oneida, 375 F.3d 206, 219 (2dCir . 2004) i Shannon v. N.Y. Ci ty Trans i t Auth. , 332 F.3d 95, 98 (2dCir . 2003). The burden of demonst ra t ing the absence of any genuinedispute as to a mater ia l fac t r e s t s upon th e par ty seeking summaryjudgment, see Adickes v. S. H. Kress & Co., 398 U.S. 144, 157, 90S. Ct. 1598, 1608 (1970), but once a prope r ly supported motion fo rsummary judgment has been made, the burden s h i f t s to the nonmovingpar ty to make a s u f f i c i e n t showing to e s t a b l i s h the e s s e n t i a lelements of t h a t p a r t y ' s case on which it bears the burden of proofa t t r i a l . See Hayut v. Sta te Univ. of N.Y., 352 F.3d 733, 743 (2dCir . 2003) (c i t ing Celotex , 477 U.S. a t 322 1 106 S. C t. a t 2552).Where, as here a cour t cons iders cross-mot ions fo r summaryjudgment, the cour t app l ies th e same l e g a l p r i n c i p l e s and "musteva lua te each pa r ty1s motion on i t s own m eri t s taking care in eachins tance to draw a l l reasonab le i n fe rences aga ins t the par ty whosemotion i s under cons idera t ion . 1I Make the Road by Walking, Inc. v.Turner, 378 F.3d 133 1 142 (2d Cir . 2004) (c i ta t ions omit ted) .

Here, the p a r t i e s do not di spu te the e s s e n t i a l fac t s . Theonly i s sue before the Court i s th e l e g a l conclusion r e su l t i n g fromthose f a c t s .

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B. The Administ ra t ive Procedure Act"The APA author izes s u i t by '" [a ] person su f fe r ing l ega l wrong

because of agency ac t ion , o r adverse ly af fec ted o r aggr ieved byagency ac t ion within the meaning of th e r e levan t s t a t u t e . " Nortonv. S. Utah Wilderness All iance ("SUWA"), 542 U.S. 55, 61, 124 S.c t . 2373, 2378 (2004) (quoting 5 U.S.C. 702). Under th e APA, an"agency ac t ion" inc ludes the " f a i l u r e to a c t . II 5 U.S.C. 551(13).8 Sec t ion 706(1) provides r e l i e f fo r an agency's f a i l u r eto ac t by empowering reviewing cour ts to "compel agency ac t ionunlawful ly withheld o r unreasonably delayed[ . ] II 5 U.S.C. 706(1) ;see SUWA, 542 U.S. a t 62; 124 S. Ct. a t 2378. The Supreme Courthas made c l e a r tha t 706(1) app l ies only when an "an agency fa i ledto take a disc re te agency act ion t ha t it i s requi red to t ake . 1ISUWA, 524 U.S. a t 64, 124 S. C t. a t 2379 (emphasis i n o r ig ina l ) ;see a l so Benzman v. Whitman, 523 F.3d 119, 130 (2d Cir . 2008). Th el im i t to disc re te ac t ions prec ludes a cour t from au thor iz ing "broadprogrammatic a t t ack[s ]" on agency po l icy , and the l i m i t to l ega l lyrequi red ac t ions ensures t ha t a cour t w i l l not i n t e r fe re with anagency 's d i sc re t ionary func t ions . See id . a t 64-65, 124 S. C t.a t 2379-80. Accordingly , "when an agency i s compelled by law to

8 Spec i f i ca l ly , the APA provides t ha t " 'agency ac t ion 'includes the whole o r a pa r t of an agency ru le , orde r , l i cense ,sanc t ion , r e l i e f , or the equiva lent or den ia l the reof , o r f a i l u r eto ac t [ . ] " 5 U.S.C. 551(13) .

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ac t within a cer ta in t ime per iod , but the manner of i t s act ion i sl e f t to the agency ' s disc re t ion , a cour t can compel the agency toac t , bu t has no power to spec i fy what the act ion must be . 1I Id . a t65, 124 S. Ct. a t 2380. The Court fu r the r expla ined t ha t thepurpose of the l imi ta t ions under 706(1) " i s to p ro t e c t agenciesfrom undue j ud i c i a l i n t e r fe rence with t h e i r l awfu l disc re t ion , andto avoid j ud i c i a l entanglement in a bs t r a c t pol icy disagreementswhich cour ts lack both exper t i se and in format ion to reso lve ." Id .a t 66, 124 S. C t. a t 2381.I I . Appl ica t ion

Here, the Direc to r of the BVM, i s sued the pen ic i l l i n andt e t racyc l ines NOOHs pursuan t to 21 U.S.C. 360b(e) (1) , whichgoverns the withdrawal of approval of NADAs/ANADAs. Spec i f i ca l ly , 360b{e) (1) reads :

The Secretary sha l l / a f t e r due no t ice and oppor tuni ty fo rhear ing to the app l ican t , i s sue an order withdrawingapproval of an app l i ca t ion . . . with r espec t to any newanimal drug i f the Secre ta ry f inds . (B) t ha t newevidence not contained in such app l i ca t ion o r notavai lab le to the Secre tary u n t i l a f t e r such app l i ca t ionwas approved/ or t e s t s by new methods, o r t e s t s bymethods not deemed reasonably appl icable when suchapp l i ca t ion was approved/ eva lua ted toge ther with theevidence avai lab le to the Secretary when the app l i ca t ionwas approved/ shows t ha t such drug i s not shown to besafe fo r use under the condi t ions of use upon the bas i sof which the app l i ca t ion was approved .

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21 U.S.C. 360b(e} (1) (B}.9 In order to ob ta in the r e l i e f theyseek , Pla in t i f f s must e s t a b l i s h t ha t 360b{e) (1 ) l e ga l ly requiresthe FDA to take a disc re te act ion .

A. Discre te ActionPla in t i f f s main ta in t ha t 36 Ob (e) (1 ) presc r ibes a s e t of

disc re te ac t ions to be taken by the FDA in the event t ha t newevidence shows t ha t a new animal drug has not been shown to besa fe . The s t a t u t e r equ i res t ha t p r i o r to i ssu ing an orde rwithdrawing approval of a NADA/ANADA, the FDA must provide no t iceto the drug sponsors and an oppor tun i ty fo r a hear ing . See 21U.S.C. 360b{e) (1) . I f a drug sponsor or o the r i n t e r e s t e d par tyt imely reques ts a hear ing , the FDA must hold a publ ic ev iden t ia ryhear ing pr i o r to suing a f i na l withdrawal order .

The FDA has promulgated numerous regula t ions to guide thewithdrawal process . Fi r s t , the not ice i s sued by the FDA "mustconta in enough informat ion to provide th e respondent a genuineoppor tuni ty to i de n t i mater ia l i s sues of fac t . " Hess & Clark,Div. of Rhodia, Inc . v. Food & Drug Admin. ("Hess & Clark") , 495F.2d 975, 983 (D.C. Cir . 1974) i see also Rhone-Poulenc, Inc . , Hess& Clark Div. v. Food & Drug Admin. ("Rhone-Poulenc"), 63 6 F.2d 750,

9 Sect ion 360b(e) (1) l i s t s s ix f indings by the Secretaryt ha t prompt withdrawal . See 21 U.S.C. 360b{e) (1) (A)-(F) . Themost r e levan t f indings fo r the presen t ac t ion a re those descr ibedin subsec t ion (B).

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752 (D.C. Cir . 1980); 21 C.F.R. 514.200(a) . I f a NADA/ANADAapp l ican t reques ts a hear ing, he must submit , in wri t ing , anexplana t ion of why the NADA/ANADA "should not be withdrawn,together with a well organized and fu l l - f ac tua l analys is of thec l in i ca l and other inves t iga t iona l data he i s prepared to prove insupport of h is oppos i t ion to the [proposed withdrawal] " 21 C.F.R. 514.200(c) . I f , i n h i s app l i ca t ion fo r a hear ing, an app l ican tfa i l s to ra i se a genuine and s ubs t a n t i a l i ssue of fac t , theCommissioner may deny the reques t fo r a hear ing and summarilywithdraw approval fo r the NADA/ANADA based on the da ta presented inthe or ig ina l no t i ce . ; Hess & Clark, 495 F.2d a t 984-85(approving the FDA's use of the summary judgment procedure wherethe NOOH presen t s a "prima fac ie case fo r withdrawal") . I f ahear ing i s granted, " the i ssues w i l l be def ined, an Administra t iveLaw Judge wil l be named, and he sha l l i s sue a wri t t en no t ice of thetime and place a t which the hear ing w i l l commence." 21 C.F.R. 514.200 (c ) . The purpose of the hear ing i s to provide a " fa i rdeterminat ion of re levant fac ts cons i s t en t with the r i gh t of a l lin te res ted persons to par t i c i pa t e . " 21 C.F.R. 12.87. Atthe hear ing, the FDA has the i n i t i a l burden of producing evidencet ha t the drug has not been shown to be sa fe , which i s genera l lycontained in the not ice . See Rhone-Poulenc, 636 F.2d a t 752;(Enrof loxacin Decis ion a t 8.) However, the drug sponsor has the

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B. Legal ly Required ActionTh e p a r t i e s di spu te whether, given the f a c t s of t h i s case ,

360b(e) (1) l ega l ly r equ i res th e Commissioner of th e FDA to holdwithdrawal proceedings fo r the r e levan t p e n i c i l l i n andt e t racyc l ines NADAs/ANADAS. Defendants acknowledge t ha t 360b(e) (1 ) conta ins language mandating the Secre ta ry to a c t ( " [ t ]heSecre ta ry s ha l l , a f t e r due no t ice and oppor tun i ty fo r hear ing toth e app l ican t , i s sue an orde r withdrawing approval of anap p l i c a t i o n . . if th e Secre ta ry f inds ... " ) . See N a t ' l Ass 'nof Home Bui lders v. Defenders of Wild l i fe , 551 U.S. 644, 661-62,127 S. Ct. 2518, 2531-32 (2007) ( in t e rp re t ing th e s t a tu to rylanguage " sh a l l approve" to impose upon the agency a mandatoryduty) i Lopez v . Davis, 53 1 U.S. 230, 241, 121 S. Ct. 714, 722(2001) (not ing Congress ' "use o f a mandatory ' s h a l l ' toimpose d i sc re t i o n l e s s ob l iga t ions" ) ; Lexecon Inc . v . Milberg WeissBershad Hynes & Lerach, 523 U.S. 26, 35, 118 S. Ct. 956, 962 (1998)( \\ [T] he mandatory ' s h a l l ' normal ly c re a t e s an ob l iga t ionimpervious to j u d i c i a l d i s c r e t io n . " ) . However, Defendants disagreewith P l a i n t i f f s as to when and how the Se c re t a ry ' s duty to a c tt r iggered . Defendants contend t h a t th e s t a t u t e only r equ i res th eSecre ta ry to withdraw approval of a NADA/ANADA i f th e Secre ta rymakes a f inding a f t e r a formal hear ing . Since th e FDA never he ldhear ings and has now withdrawn th e 1977 NOOHs, Defendants argue

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t ha t no f ind ings have been made and no fu r t h e r ac t ion requi red .P l a i n t i f f s contend t ha t under 360b(e) (1 ) the Sec re t a ry makes af ind ing p r i o r to a hear ing , and t h a t upon making such a f ind ing ,the Secre ta ry i s l e g a l l y requi red to withdraw approval of a drug,unless the drug sponsor reques t s a hear ing and shows t ha t the drugi s sa fe . They fu r t h e r argue t h a t th e FDA's recen t withdrawal ofthe 1977 NOOHs does n ot d i s tu rb the agency ' s o r i g i n a l f indings andt ha t the FDA i s l e g a l l y requ i red to hold withdrawal proceedings fo rthe r e levan t pen i c i l l i n and t e t r a c y c l i n e s NOOHs. The ques t ionbefore the Cour t i s whether the FDA i s l e ga l ly requ i red to proceedwith the hear ing and withdrawal p ro cess .

1 . Sta tu to ry In t e rp re t a t i o na . Legal StandardIn i n t e rp re t i n g a s t a t u t e , a cour t "must give e f f e c t to the

unambiguously expressed i n t e n t of Congress . II Chevron, U. S. A ., Inc .v . Natura l Res. Def. Counci l , Inc. t 467 U.S. 837 t 843/ 104 S. Ct.2778, 2781 (1984). "To a sc e r t a i n Congress ' s i n t e n t [a court]beg in [s] with the s t a tu to ry t e x t because i f i t s language i sunambiguous/ no fu r t h e r inqui ry i s necessary.1I Cohen v . JP MorganChase & CO. 498 F.3d 111/ 116 (2d Cir . 2007) ( c i t a t i ons omit ted) itsee a l so Tyler v . Douglas, 280 F.3d 116/ 122 (2d Cir . 2001) ( ' ' ' I fth e s t a t u t o ry terms are unambiguous, [a cour t t s J review gene ra l lyends and th e s t a t u t e i s const rued accord ing to th e p l a i n meaning of

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i t s words. ' I I) {quoting Sul l ivan v. Cnty. of Suffo lk , 174 F.3d 282,285 (2 d Cir . 1999 . S ta tu tory i n t e rp re ta t ion must take i n toaccount the "s t ruc ture and grammar" of the provis ion . See B10atev. United Sta t e s , U.S. , - - , 130 S. Ct. 1345, 1354-55 (2010).\\ I f the s t a tu to r y language i s ambiguous, however, [a cour t] wi l l' r e so r t f i r s t to cannons of s t a tu to ry cons t ruc t ion , and, i f the[ s ta tu tory] meaning remains ambiguous, to l e g i s l a t i v e h i s to r y ' II todetermine the i n t en t of Congress. Cohen, 498 F.3d a t 116 {quotingDaniel v. Am. Bd. of Emergency Med., 428 F.3d 408, 423 (2d Cir .2005 . the i n t en t Congress remains unclear , a cour t wi l ldefe r to an agency ' s i n t e rp re ta t ion of the s t a t u t e , so long as iti s " reasonable ." See Chevron, 46 7 U.S. a t 843-44, 104 S. Ct. a t2782.

b. Appl ica t ion : Findings Pursuant to 360b(e) (1 )Here, the s t a tu t e unambiguously commands the Secre tary to

withdraw approval of any new animal drug t h a t he f inds not shownto be sa fe , provided t h a t the sponsor of the animal drug has not iceand an oppor tuni ty fo r a hear ing . See 21 U.S.C. 360b{e) (1) . Thes t a tu te does not exp l i c i t l y s t a t e the order in which t h i s processmust occur . Defendants maintain t h a t the Secre tary can only i ssuea f ind ing a f t e r a hear ing , whereas Pla in t i f f s cla im the Secre tarymakes a f ind ing f i r s t , which then t r i gge r s the Secre t a ry ' sob l iga t ion to provide no t ice and an oppor tuni ty fo r a hear ing .

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The Court f inds t ha t P la in t i f f / s i n t e rp re t a t ion provides acommon sense reading of the s t a tu t e based on i t s t ex t andgrammatical s t ruc tu r e . The s t a t u t e s t a t e s t ha t " [ t ]he Secretarys ha l l a f t e r due not ice and oppor tuni ty fo r hear ing to theapp l ican t issue an order withdrawing approval of a[] [NADA/ANADA]

i f the Secretary f inds . . . [ tha t a drug i s not shown to beIIsafe] The "a f t e r due not ice and oppor tuni ty fo r hearingll

clause i s se tof f by commas and immediate ly precedes the words"issue an order withdrawing approval 1 i nd ica t ing t ha t the "not ice llIIclause modif ies the " issue an order ll clause and not the f indingsclause . See United Sta tes v . Liranzo 729 F. Supp. 1012 1 1014(S.D.N.Y. 1990) ( in te rpre t ing a modif ie r to apply to the verbc loses t to i t ) (c i t ing W. Strunk l J r . & E.B. White The Elements ofStyle 30 (3d ed. 1979)) . AccordinglYI the s t a tu t e only r equ i resthe Secretary to give not ice and provide an oppor tuni ty fo r ahear ing before i ssu ing an order of withdrawal and not before makingf indings . Under t h i s reading 1 i f the Secretary f inds t ha t ananimal drug has not been shown to be safe he i s s t a tu to r i lyrequired to withdraw approval of t ha t drug provided t ha t the drugsponsor has not ice and an oppor tuni ty for a hear ing. See RhonePoulenc 1 636 F.2d a t 752 ("[T]he Commissioner must withdraw h isapproval [of an animal drug] whenever he f inds t ha t 'new evidence

1 II )shows t ha t such drug i s not shown to be safe

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(quot ing 21 U.S.C. 360b(e) (1) (B)) . I f , a f t e r a hear ing , th e drugsponsor has n o t met h is burden of proving th e drug to be sa fe , th es ec r e t a r y must i s sue a withdrawal order.11

The t e x t and grammar o f o t h e r p rov i s ions with in 360b suppor tt h i s i n t e rp re t a t i o n . For example, 360b(d) (1 ) exp l i c i t l y requ i re sth e Secre ta ry to prov ide not i ce and an oppor tun i ty fo r a hear ingbefore making f ind ings regard ing th e approval o r r e f u s a l o f a NADA.

21 U.S.C. 360b(d) (1 ) . Sect ion 360b (d ) (1) reads : " I f th eSec re t a ry f inds , a f t e r due no t ice to th e a p p l i c a n t ... and giv inghim an oppor tun i ty fo r a hear ing , he s h a l l i s sue an o rd e rre fus ing to approve th e ap p l i ca t i o n . " By plac ing the "not ice"c lause immediate ly a f t e r th e phrase " [ i J f the Sec re t a ry f inds , " 360b(d) (I) c l e a r ly requ i re s no t i ce and an oppor tun i ty fo r a hear ingp r i o r to the i ssuance of f ind ings by th e Sec re t a ry . The f ac t t h a t

Congress used such language in 360b(d) ( I ) and used d i f f e r e n tlanguage in 360b{e) (1) suppor t s the C o u r t ' s conclus ion t h a tnot i ce and an oppor tun i ty fo r a hear ing a re not requ i red before theSecre ta ry makes f ind ings under th e l a t t e r prov i s ion . Novel lav . Westches te r Cnty . , 661 F.3d 128, 142 (2d r . 2011) {explainingt h a t the presence o f a term in one prov i s ion and no t in ano ther was

11 Admit tedly , th e Sec re t a ry w i l l make a second se t off ind ings a f t e r a hear ing , but th e i n i t i a l f ind ings t r i g g e r th emandatory withdrawal p ro ces s and, i f no t rebu t t ed , prov ide abas i s fo r mandatory withdrawal .

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del ibera te and meaningful) .Moreover, 360b(e) (1) inc ludes a spec i f ic note about the

not ice and hear ing requirement when the Secretary f inds t ha t a newanimal drug poses an imminent r i sk to humans or animals , whichind ica tes tha t f indings are made before a hear ing. Spec i f ica l ly ,the s t a t u t e s t a t e s t ha t

[ i ] f the Secretary (or in h is absence the of f i ce r act ingas Secretary) f inds t ha t there i s an imminent hazard tothe heal th of man o r of the animals fo r which such drugi s in tended, he may suspend the approval of suchappl ica t ion immediately, and give the appl icant promptnot ice of h is act ion and af fo rd the appl icant theoppor tuni ty fo r an expedi ted hear ing under th i ssubsec t ion .

21 U.S.C. 360b(e) (1) . This provis ion a n t i c ipa t e s the Secretarymaking f indings in advance of a hear ing i otherwise , the c lauserequir ing the Secretary to provide not ice and an oppor tuni ty for anexpedited hear ing would be redundant and nonsens ical . The Courtcannot adopt such an in te rpre ta t ion . Conn. ex r e I . Blumenthalv. Dep ' t of In t e r i o r , 228 F.3d 82, 88 (2d Cir . 2000) (".[cour ts] are required to ' d i s favor in te rpre ta t ions of s t a t u t e s t ha trender language super f 1uous . ' (quot ing Conn. Na t 'I Bank v.I )Germain, 503 U.S. 249, 253, 112 S. Ct. 1146, 1149 (1992.Although the Secre ta ry ' s au thor i ty to make a f inding of imminent

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hazard " sh a l l not be de lega ted , " th e f a c t t ha t t h i s f inding i s madebefore not ice o r an oppor tuni ty fo r a hear ing a re prov ided supportst h a t f indings pursuan t to 360b(e) (1) a re made p r i o r to a hear ing .This i n t e rp r e t a t i on i s fu r the r bu t t ressed by the s t a tu to ry purposesunder ly ing th e FDA, the agency tasked with implementing 360b (e) (1) and the FDCA. Spec i f i ca l ly , the FDA "sha l lpromote the publ ic hea l th by prompt ly and e f f i c i en t ly reviewingc l i n i c a l research and t ak ing appropr i a t e ac t ion on the market ing ofregula ted products in a t imely manner; [and] with r espec t to suchproduct s , p ro t e c t the publ ic hea l th by ensur ing t h a t . . humanand ve te r ina ry drugs are safe and e f f e c t i v e [ . ] " 21 U.S.C. 393 (b) (1) ( 2 ) . According to i t s s t a tu to ry mandate , the FDA i srespons ib le fo r cont inuously monitoring regula ted drugs andreviewing new s tud ies of t h e i r e f f ec t i v en es s and sa fe ty . Givent h i s regu la to ry s t ru c t u re , it seems c l e a r tha t Congress in tendedthe FDA to monitor approved animal drugs and i s sue f indings whennew evidence i n d i ca t e s t ha t a drug i s no longer shown to be sa fe ,t r igger ing the withdrawal process .

Accordingly , based on the t e x t and grammar o f 360b(e) (1) , aswel l as the s t ru c t u re o f 36 Ob as a whole and th e ove r r id ingpurpose of th e FDA, the Cour t f inds t ha t th e p l a i n meaning of 360b (e) (1) r equ i res th e Sec re t a ry to i s sue no t ice and anoppor tun i ty fo r a hear ing whenever he f inds t ha t a new animal drug

i f

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i s not shown to be sa fe . I f th e drug sponsor does n ot meet h isburden of demonstra t ing t ha t the drug i s safe a t the hear ing , theSecre ta ry must i s sue an orde r withdrawing approval of the drug.

This i n t e rp r e t a t i on i s cons i s t en t with how cour ts havei n t e rp re ted 21 U.S.C. 355 (e) , the human drug p a r a l l e l to 360b(e) . Food & Drug Admin. v. Brown & Will iamson TobaccoCorp., 529 U.S. 120, 134, 120 S. Ct. 1291, 1301 (2000) ("If the FDAdiscovers a f t e r approval t ha t a drug i s unsafe o r ine f fec t ive , it\ s ha l l , a f t e r due no t ice and oppor tuni ty fo r hearing to theapp l ican t , withdraw approva l ' of the drug." ) (quoting 21 U.S.C. 355(e) (1)-(3 i Mylan Labs. , Inc. v. Thompson, 389 F.3d 1272, 1281(D.C. Cir . 2004) (" [S]ect ion 355(e) s imply se t s ou t spec i f ic , notneces sa r i ly exc lus ive , c i rcumstances under which the FDA mustwithdraw any [human drug] approval (whether f i na l o r otherwise)a f t e r not ice and hear ing ." ) i Dobbs v. Wyeth Pharms. I 797 F. Supp. 2d1264, 1270-71 (W.D. Okla. 2011) ( "The FDA i s s t a tu to r i lyrespons ib le fo r con t inua l ly monitor ing the sa fe ty o f approved drugsand i s author ized to take ac t ions inc luding l i n t e r a l i a , withdrawalof approval i f sc i en t i f i c data i nd ica tes the drug i s unsafe . 21U.S.C. 355(e) . Approval must be withdrawn i f the FDA f inds t ha t

[a ] drug i s unsafe fo r use [ . ] II ) ( in t e rna l quota t ion marksomit ted) . Although 355 (e ) concerns wi thdrawal of FDA approval o fhUman drugs, it conta ins near ly i de n t i c a l language to t ha t in

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360b(e) , and, in both the House and Senate Repor ts on the 1968Amendments to the FDCA, 360b(e) was descr ibed as"correspond [ing] " to 355 (e ) . H.R. Rep. No. 90 875, a t 5(1967) i S. Rep. No. 90-1308, a t 5 (1968).

Were the Court to conclude t ha t 360b(e) (1) i s ambiguous asto when the Secretary makes f indings , the Court would defe r to theagency 's reasonable i n t e rp re t a t i on of the s t a tu t e . See Chevron,467 U.S. a t 842-43, 104 S. C t. 2781-82. Although in th i sI i t iga t ion the FDA has maintained t ha t f indings pursuant to 360b(e) (1 ) can only be made a f t e r a hear ing, the agency'simplementing regula t ion , 21 U.S.C. 514.115, i n t e rp re t s 360b(e} (1 ) to requi re the agency to make f indings pr i o r to ahear ing. The regula t ion reads : "The Commissioner sha l l not i fy inwri t ing the person holding [a NADA/ANADA] and af fo rd an oppor tuni tyfo r a hearing on a proposal to withdraw approval of such[NADA/ANADA] i f he f inds . . t ha t such drug i s not shown to besafe . 21 C.F.R. 514.115(b) (3) (i i) .12 The pla in languageof the regula t ion requi res the Commissioner to provide not ice andan oppor tuni ty for a hear ing to a drug sponsor a f t e r making a

12 Although 360b(e) (1) re fe r s to the "Secretary ," def inedas the Secretary of HHS in 321(d) , the Secretary has delega tedto the Commissioner of the FDA a l l of the author i ty ves ted in himpursuant to the FDCA. (See 1410.10 of Volume I I I of the FDASta f f Manual Guides, Delegat ions of Author i ty to the CommissionerFood and Drugs, at tached as Ex. A to Barcelo Decl . , l(A) (1) . )

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f inding t ha t a drug has no t been shown to be sa fe . I t log ica l lyfo l lows t ha t f indings a re made by the Commissioner before ahear ing . 13 Accordingly, i f the Court were to defe r to the agency 'si n t e rp r e t a t i on of th e s t a t u t e it would reach the same conclus ion:f indings pursuant to 360b(e) (1) are made before a hear ing andt r i gge r the withdrawal process .

Defendants , never the les s , argue t ha t th e r egu la t ion does no tmean what it says . They claim t ha t the r egu la t ion does not r e fe rto the same f indings as those in 360b(e) (1) ; r a t h e r , Defendantsa s s e r t t ha t the r egu la t ion crea tes a d i f fe ren t s e t of f indings t ha ta re based on a lower s tandard than the s t a tu to ry f indings . Tosupport th i s propos i t ion , Defendants po in t to s evera l no t ices of

13 Moreover, t h i s i n t e rp r e t a t i on i s cons i s t en t with how theFDA has implemented 360b(e) (1 ) and the accompanying r egu la t ionsin p ra c t i c e . The FDA cons i s t en t ly r ep resen t s 360b(e) (1) asr equ i r ing no t ice and an oppor tuni ty fo r a hear ing on a proposedwithdrawal whenever there i s a f inding t h a t a new animal drug hasnot been shown to be sa fe . Findings are cons i s t en t ly madepursuant to 360b{e} (1) p r i o r to a hear ing and provide thegrounds for i s su ing a no t ice and oppor tuni ty fo r a hear ing . SeeEnrof loxacin fo r Poul t ry ; Opportuni ty fo r Hearing ("Enrof loxacinNot ice") , 65 Fed. Reg. 64,954, 64,954 (Oct. 31, 2000) ("CVM i sproposing to withdraw the approval of the [NADA] fo r use ofenrof loxac in in pou l t ry on the grounds t ha t new evidence showst ha t the produc t has not been shown to be safe as provided fo r inthe [FDCA] . " ) ; Dimetr idazole ; Oppor tuni ty fo r Hearing("Dimetr idazole Not ice") , 51 Fed. Reg. 45,244, 45,244 (Dec. 17,1986) ("The [FDA], [CVM], i s proposing to withdraw approval of[NADAs] fo r d im e t r ida z o le . . fo r use in turkeys . This ac t ioni s based on the [CVM's] dete rmina t ion t h a t the drug i s no t shownto be sa fe fo r u s e . .") .

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not contained in such app l i ca t ion o r not ava i l ab le to the Secre ta ryu n t i l t e r such app l i ca t ion was approved/ o r t e s t s by new methods/o r t e s t s by methods no t deemed reasonably app l icab le when suchapp l ica t ion was approved, eva lua ted toge ther with the evidenceavai lab le to the sec re ta ry when the app l i ca t ion was approved/ showst ha t such drug i s no t shown to sa fe fo r use under the condi t ions ofuse upon the bas i s of which the app l i ca t ion was approved") . Basedon t h i s language, the r egu la t ion unambiguously references andincorpora tes the f indings re fe r red to in 360b(e) (1) . Inadd i t ion , the Commissioner cons iders the two f indings to bein te rchangeable . (Enrof loxacin Decis ion a t 45 (" [T] he r e levan ts t a tu to ry ques t ion i s whether the animal drug 'has been shown to besa fe , ' 21 U.S.C. 360b(e) (1), which/ as explained e a r l i e r , hasbeen i n t e rp re ted to r equ i re t ha t CVM show t ha t the re a re s e r iousques t ions about the sa fe ty of [ the drug] . /1 ) . )

Because the Court reads 21 C.F.R. 514.115 (b) (3) asunambiguously referencing the f indings in 21 U.S.C. 360b(e) (1) ,the Court cannot defe r to Defendants ' i n t e rp r e t a t i on tha t ther egu la t ion crea tes a d i f f e r e n t s e t o f f indings based on a d i f f e r e n ts tandard . Chr i s tensen v. Harr i s Cnty. , 529 U.S. 576, 588/ 120S. Ct. 1655, 1663 (2000) ("[A]n agency ' s i n t e rp r e t a t i on of i t s ownr egu la t ion i s en t i t l ed to deference . But [such] deference i swarranted only when th e language of the regula t ion i s ambiguous./I)

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( in t e rna l c i t a t i ons omit ted) ; Gonzalez v. Oregon, 546 U.S. 243,257, 126 S. Ct. 904, 915-16 (2006) ( refus ing to apply deference toan agency 's i n t e rp r e t a t i on o f i t s own regula t ion where ther egu la t ion merely "parro tedH the s t a tu t e because " [a]n agency doesnot acqui re spec ia l au thor i ty to i n t e rp re t i t s own words when,in s tead of us ing i t s exper t i se and experience to formulate ar egu la t ion , it has e lec ted merely to paraphrase the s ta tu torylanguage. fl ) . 1 4

c . Appl ica t ion : Author i ty of the Direc to r of the BVMDefendants asse r t t ha t even i f a f inding t r i gge r s the FDA's

ob l iga t ions pursuan t to 360b (e) (1) , the re have been no suchf indings in t h i s case . Defendants maintain t ha t the Direc to r ofthe BVM, who i s sued the 1977 NOOHs, i s not au thor ized to makef indings pursuant to 360b(e) (1) . The s t a t u t e does not exp l i c i t l yauthor ize the Direc to r to make f indings , and Defendants the re fo reargue t ha t the Court should defer to the agency ' s pos i t ion t ha t theDirec to r of the BVM not author ized to make the r e qu i s i t ef indings . See Chevron, 467 U.S. a t 842-43, 104 S. Ct. a t 2781 82.

14 In any event , the 1977 NOOHs a t i s sue in t h i s case werebased on f indings t ha t the drug uses in ques t ion were "not shownto be safe" and not on the "ser ious quest ion" s tandard . And, theCourt i s not ca l led on here to determine whether the s tandard fo rwithdrawal of approval has been met. The only i s sue present lybefore the Court i s whether the withdrawal process must moveforward.

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As discussed supra, i f a cour t determines t ha t a s t a t u t e i sambiguous and t ha t "Congress has no t d i rec t l y addressed the preciseques t ion a t issue,H th e cour t must defe r to an agency 's"reasonable" in te rpre ta t ion of th e s t a tu t e it adminis ters . rd . a t842 44, 104 S. Ct. a t 2781 82. "[An] admin is t r a t ive implementationof a par t i cu l a r s t a tu to ry provis ion qua l i f i e s fo r Chevron deferencewhen it appears t ha t Congress de lega ted author i ty to the agencygenera l ly to make ru le s car ry ing the force law, and tha t theagency in te rpre ta t ion claiming deference was promulgated in theexerc ise of t ha t authori ty .H United Sta tes v. Mead Corp. , 533 U.S.218, 226-27, 121 S. Ct. 2164, 2171 (2001). An agency has beende lega ted such au thor i ty i f it has the "power to engage inad jud ica t ion o r notice-and-comment rulemaking" o r i f the re i s "someo ther i nd ica t ion of a comparable congress iona l in ten t . " , a t227, 121 S. Ct. a t 2171. Factors to cons ider when determiningwhether th e Chevron framework app l ies to an agency in te rpre ta t ioninclude "the i n t e r s t i t i a l na ture of the l ega l ques t ion , the re la tedexper t i se of the [a ] gency, th e importance of the ques t ion toadminis t ra t ion of the s t a t u t e , the complexi ty of t ha tadminis t ra t ion , and the ca re fu l cons idera t ion the [a ] gency has

Hgiven the ques t ion over a long per iod of t ime . Barnhar t v.Walton, 535 U.S. 212, 222, 122 S. Ct. 1265, 1272 (2002). The

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Medicated Feed Mil l License Appl ica t ions ("Staf f Manual") , at tachedas Ex. A to Barcelo Decl . , I(A) (1 ) - (2 ) . ) The ques t ion before theCourt i s whether the au thor i ty delega ted to Di rec to r includesthe au thor i ty to make f indings t ha t t r i gge r the FDA's non-d i sc re t ionary du t ies pursuant to 360b(e) (1 ) .

Defendants urge the Court to defe r to t h e i r i n t e rp r e t a t i ont h a t the Direc to r does no t have au thor i ty to make such f ind ings .Defendants argue t ha t because th e Commissioner d id not delega teau thor i ty to the Direc to r to i s sue orde rs of withdrawal a f t e r ahear ing , the Direc to r cannot make the f indings necessary to t r i gge rthe FDA's non d i sc re t ionary du t i es under 360b(e) (1) . However,th i s argument hinges on Defendants ' i ncor rec t i n t e rp r e t a t i on of 360b(e) (1), whereby a f inding can be made only a f t e r a hear ing . Asth e Court reads 360b(e) (1) and the accompanying r egu la t ions tocontemplate f indings made p r i o r to a hear ing , Defendants ' i anceon the St a f f Manual i s of no ava i l . In fac t , the de lega t ionswi th in the Sta f f Manual suppor t P l a i n t i f f s ' pos i t ion t ha t the FDAi s l ega l ly requ i red to r e - i n s t i t u t e withdrawal proceedings fo rpen i c i l l i n and t e t racyc l ines in animal feed.

By author iz ing the Direc to r to i s sue no t ices of an oppor tuni tyfo r a hear ing , the Commissioner necessa r i ly author ized the Direc to rto make the f indings on which such no t ices of withdrawal a re based.Any not ice i s sued must "spec i fy the grounds upon which" th e

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proposa l to withdraw i s based . 21 C.F.R. 514.200(a ) . Under boththe s t a t u t e and the r egu la t ion , a proposa l to withdraw may be basedon a f inding t ha t an animal drug has not been shown to be sa fe .See 21 U.S.C. 360b(e) (1) (B); 21 C.F.R. 514.115(b) (3) ( i i ) . Inprac t i ce , the Direc to r genera l ly s t a t e s h is conclusion t h a t thedrug has not been shown to be safe and c i t e s 360b(e) (1) . SeeDimetr idazole ; Oppor tuni ty fo r Hearing, 51 Fed. Reg. 45,244, 45,244(Dec. 17, 1986) ("This [not ice of i n t e n t to withdraw approval] i sbeing [issued] in accordance with sec t ion 512(e) (1 ) (B) of theFedera l Food, Drug, and Cosmetic Act ( the ac t ) (21 U.S.C. 360b(e) (1) (b)) . That sec t ion r equ i res FDA to withdraw approval ofan NADA i f the agency f inds . . . t ha t such drug i s not shown to besa fe [T]he Center [ for Vete r inary Medicine] has determinedt ha t dimet r idazole i s not shown to be safe fo r use within themeaning of sec t ion o f 512 (e) (1) (B) [ .] ") (emphasis added);Enrof loxac in Not ice , 65 Fed. Reg. a t 64,954 ("CVM i s proposing towithdraw the approva l of the new animal drug app l i ca t ion fo r use ofenrof loxac in in pou l t ry on the grounds t ha t new evidence shows t ha tthe produc t has not been shown to be safe as provided fo r in th eFedera l Food, Drug, and Cosmetic Act . . II ) (emphas i s added) .I t i s c l e a r from th e FDA's own prac t i ce t ha t the Direc to r of theBVM i s author ized to make the r e qu i s i t e f indings t ha t t r i gge rwithdrawal proceedings pursuant to 360b(e) (1) . Accordingly , by

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1

guidance speci fy ing the l imi t s of the D ire c to r ' s delega tedauthor i ty to which the Court could defer . Moreover, in prac t ice ,the Direc to r rou t ine ly exerc ises the author i ty t ha t the FDA nowcla ims the Direc to r lacks . The Court cannot defer to anin te rpre ta t ion tha t the FDA appears to have adopted so le ly fo r

iga t ion purposes . See Bowen v. Georgetown Univ. Hosp. , 488 U. S.204, 212, 109 S. Ct. 468, 473-74 (1988) (" [The Supreme Court] h[as]never appl ied the pr inc ip le of [Chevron deference] to agencyl i t iga t ing pos i t ions t ha t are wholly unsuppor ted by regula t ions ,ru l ings , or admin is t r a t ive prac t i ce . " ) . Final ly , any doubt t ha tthe Director was author ized to i s sue the f indings in the 1977 NOOHsi s conclus ively dispe l led by the Commissioner 's acknowledgment andendorsement of the D ire c to r ' s f indings . Penic i l l in andTetracycl ine in Animal Feeds, 48 Fed. Reg. 4,554, 4,556 (Feb. 1,1983).

2. Findings Regarding the Subtherapeut ic Use of Penic i l l inand Tetracycl ines

Having found t ha t the Direc to r of the BVM author ized tomake f indings under 360b(e) (1), the ques t ion becomes whether theDirector made such f indings fo r the subtherapeut ic usepen ic i l l i n and t e t r a c yc l ine s . In the 1977 Penic i l l in Notice, theDirec to r s t a t ed t ha t he i s

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unaware of evidence tha t s a t i s f s the requirementsfo r the safe ty of penic i l l in -conta in ing premixes asrequired by [ 360b of the FDCA] and 558.15 of theagency's regula t ions . Accordingly, he concludes, onthe bas i s of new informat ion before him with r espec tto these drug products , evaluated together with theevidence ava i l ab le to him when they were or i g i na l l yapproved, t ha t the drug products are not shown to besafe The evidence , in fac t , ind ica tes t ha tsuch pen ic i l l i n use may be unsafe .

Penic i l l in Notice , 42 Fed. Reg. a t 43,792 (emphasis added).Similar ly , in the 1977 Tetracycl ine Notice, the Director s ta tedtha t he i s

unaware of evidence t ha t s a t i s f i e s the requirements fo rdemonstrat ing the safe ty of extens ive use ofsub therapeu t i c t e t r acyc l ine conta in ing premixeses tab l i shed by sec t ion [360b] of the [FDCA]Accordingly, he concludes, on the bas i s of newinformat ion before him with respect to these drugproducts , evaluated toge ther with the evidence ava i l ab leto him when they were or ig ina l ly approved, t ha t the drugproducts are safe only fo r the l imi ted condi t ions of uses e t for th [ in the Notice] .

Tetracycl ine Notice, 42 Fed. Reg. a t 56,288. Accordingly, in boththe Penic i l l in and the Tetracycl ine Notices , the Direc to rexp l i c i t l y concluded t ha t the drugs had not been shown to be safeand c i ted 360b. Such a conclus ion i s the s t a t u t o ry t r i gge r fo rthe FDA to i n s t i t u t e withdrawal proceedings , which it i n fac t did .Based on the language of the 1977 Notices, the Di rec to r made thef indings necessary to t r i gge r mandatory withdrawal proceedings fo r

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the subtherapeut ic uses of pen ic i l l i n and t e t racyc l ines in animalfeed. 15

Even i f the Court were to adopt Defendants ' in te rpre ta t iont ha t the Director i s not author ized to make the r e qu i s i t e f indingsunder 360b(e) (1) , the Court would still conclude t h a t the FDA i sl ega l ly required to hold withdrawal proceedings because theCommissioner has made the requi s i t e f indings by not ing andr a t i f y ing the Direc tor ' s f indings . In 1983, the Commissioner

publ ished a s ta tement o f po l icy in the Federa l Regis te r denyingsevera l reques ts from drug sponsors to resc ind the 1977 NOOHs, inwhich the Commissioner "concurr(ed]" with the D ire c to r ' s f indingstha t the drugs had not been shown to be sa fe . See Penic i l l in andTetracycl ine in Animal Feeds, 48 Fed. Reg. a t 4,556 (explaining theDirector of BVM's decis ion not to resc ind the 1977 NOOHs becausethey " represent the Direc tor ' s formal pos i t ion tha t use of thedrugs i s not shown to be safe" and s t a t i ng t h a t "( t ] he Commissionerhas reviewed the D ire c to r ' s decis ion and concurs with i t . " ) . Basedon t h i s concurrence , the Commissioner has adopted and, therefore ,i s sued f indings , and the 360b(e) (1 ) mandatory withdrawal

15 Furthermore, during ora l argument, counsel fo r the FDAacknowledged t ha t the Director lawful ly i s sued the NOOHS in 1977and tha t they were not u l t r a v i r e s , i nd ica t ing t h a t the Direc to rhas the au thor i ty to make f indings su f f i c i en t to i n s t i t u t ewithdrawal proceedings . (See Transcr ip t of Hearing dated Feb.23, 2012 ("Transcr ip t" ) , a t 12. )

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proceedings have been t r iggered .I I I . Mootness

A. Legal Standard" I t has long been se t t l ed t ha t a federa l cour t has no

au thor i ty ' t o give opinions upon moot ques t ions or abs t rac tpropos i t ions , or to declare pr inc ip le s or ru les of law which cannota f fec t the mat te r in i ssue in the case before it.' Church of1Scientology of Cal. v. United Sta te s , 506 U.S. 9, 12, 113 S. Ct.447, 449 (1992) (quoting Mil ls v. Green, 159 U.S. 651, 653, 16 S.Ct. 132, 133 (1895)) . "The mootness doct r ine provides t ha t 'anac tual controversy must be extant a t a l l s tages of review, notmerely a t the t ime the complaint i s f i l e d . ' 11 Conn. Office ofProtect ion & Advocacy fo r Persons with Disab i l i t i e s v. Hartford Bd.of Educ., 464 F.3d 229, 237 (2d Cir . 2006) (quoting Br i t i sh I n t ' lIns . Co. v. Seguros La Republica. S.A. , 354 F.3d 120, 122 (2d Cir .2003) ) . "The exis tence of a r e a l case or cont roversy i s ani r reduc ib le minimum to the j u r i sd i c t i on of the federa l cour ts . "United Sta tes v. City of New York, 972 F.2d 464, 469 70 (2d Cir .1992) (quoting Valley Forge Chris t ian ColI . v. Ams. United fo rSeparat ion of Church and Sta te , 454 U.S. 464, 471, 102 S. Ct. 752,757-58 (1982}). Accordingly, " i f an event occurs while a case i spending . . t ha t makes it impossible fo r the cour t to gran t anye f fec tua l r e l i e f whatever to a preva i l ing pa r ty , the [case] must be

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dismissed. 1/ Church of Scientology of Cal . , 506 U. S. a t 12, 113 S.Ct. a t 449 ( in te rna l quota t ion marks and c i t a t i o n omit ted) .

B. Appl ica t ionHere, Defendants maintain t ha t P la in t i f f s ' claim i s now moot

because, during the pendency of th i s case, the FDA resc inded the1977 NOOHs fo r the subtherapeut ic use of pen ic i l l i n andt e t racyc l ines in animal feed. See NOOH Withdrawals , 76 Fed. Reg.79,697, 79,697 (Dec. 22, 2011).

P la in t i f f s ' claim a r i se s under 706 (1) of the APA, whichauthor izes the Court to gran t Pla in t i f f s r e l i e f i f they es tab l i sht ha t the FDA led to take a l ega l ly required disc re te act ion .Pla in t i f f s contend, and the Court agrees , t ha t upon a f inding bythe FDA t ha t a new animal drug has not been shown to be safe , theFDA i s required to withdraw approval of t ha t drug a f t e r providingno t ice and an oppor tuni ty for a hear ing. Therefore, the t r i gge rfo r FDA to i n i t i a t e mandatory withdrawal proceedings i s not thei ssuance of a NOOH but a f inding t ha t a drug has not been shown tobe safe . The i ssuance of a NOOH i s s imply the f i r s t s tep in themandatory withdrawal process . Accordingly, P l a i n t i f f s are stillen t i t l ed to r e l i e f and t he i r claim i s not moot i f they canes tab l i sh t ha t the re sc i s s ion of the NOOHs d id not resc ind theFDA's f indings t ha t the subtherapeut ic use of pen ic i l l i n andt e t racyc l ines in animal feed has not been shown to be safe .

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The record makes c l e a r t ha t the FDA d id not resc ind sf indings when it rescinded the 1977 NOOHs. In the o f f i c i a l notresc inding the 1977 NOOHs, the FDA provided three j u s t i f i ca t ionsfo r the re sc i s s ion :

(1) FDA i s engaging in o ther ongoing r egu la to rys t ra teg ies developed s ince the pub l i ca t ion of the 1977NOOHs with r espec t to address ing microbia l food sa fe tyi s sues ; (2) FDA would update th e NOOHs to re f cur ren tda ta , informat ion, and pol s i f , in the fu tu re , itdecides to move forward with withdrawal of the approveduses of the new animal drugs descr ibed in the NOOHsi and(3) FDA would need to p r i o r i t i z e any withdrawalproceedings .

NOOH Withdrawals, 76 Fed. Reg. 79,697, 79,698 (Dec. 22, 2011).None of these reasons addresses th e i a l f indings t ha t prompted

NOOHs o r suggests t h a t the FDA i s resc inding those f indings .Rather, in the not ice resc inding the 1977 NOOHs, the FDA emphasizedi t s cont inuing concerns about the subtherapeut ic use of pen ic i l l i nand t e t racyc l ines . "Although FDA i s withdrawing the 1977 NOOHs,FDA remains concerned about the i s sue of an t imic rob ia l re s i s t ance .Today 's act ion should not be i n t e rp re as a s ign t ha t FDA nolonger has sa fe ty concerns or t ha t FDA wil l not cons ider re -proposing withdrawal proceedings in the fu tu re , i f necessary . IIa t 79,698. This publ ic announcement of the FDA's continuing sa fe tyconcerns and i t s a t tempts a t o ther s t r a t eg i e s support the view t ha tthe FDA has not resc inded i t s or ig ina l f indings t ha t use of the

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drugs has not been shown to be s a f e . 16In add i t ion , the 2010 Draf t Guidance, which r ep resen t s the

FDA's cur ren t s t ra t egy to address microb ia l food sa fe ty i s sues ,emphasizes th e FDA's cont inuing concerns about the sa fe ty of thesubtherapeut ic use of pen i c i l l i n and t e t r a c y c l i n e s i n animal feed .(See Guidance No. 209, a t t ached as Ex. B to Barcelo Decl . a t 4.) Inprepar ing the Guidance, th e FDA reviewed key s c i e n t i f i c s tud ies andr epor t s and concluded t h a t "the overa l l weight of evidenceava i lab le to da te supports the conclusion t ha t using medical lyimpor tant an t imic rob ia l drugs fo r product ion purposes i s not in th ei n t e r e s t of pro tec t ing and promoting th e publ ic hea l th . "a t 13. )17 The FDA has not i s sued a s ing le s ta tement s ince the

16 Any cla im t ha t the 1977 NOOHs are ou t -o f -da te does notre l i eve th e FDA of i t s ob l iga t ion to proceed with th e withdrawalprocess . Fi r s t , the agency cannot , through i t s own prolongedinac t ion , c rea te obs tac les to i t s s t a t u t o r i l y mandatedob l iga t ion . Second, while there have been ad d i t i o n a l sc i en t i f i cs tud ies s ince th e 1977 NOOHs were i s sued, they a l l appear tosuppor t the FDA's o r i g i n a l f inding t h a t th e use of these drugshas not been shown to be sa fe . F ina l ly , noth ing prec ludes theFDA from upda t ing th e NOOHs, so long as it does so in areasonably prompt manner.

17 The 2010 Dra f t Guidance recommends t ha t medica l lyimpor tant a n t i b i o t i c s , inc luding p e n i c i l l i n and t e t r a c y c l i n e s , beused " jud ic ious ly . " (See Guidance No. 209, a t tached as Ex. B toBarcelo Decl . a t 16. ) "In l i g h t of the r i sk t ha t an t imic rob ia lre s i s t ance poses to publ i c hea l th , FDA be l ieves the use ofmedica l ly important an t imic rob ia l drugs in food producing animalsfo r product ion purposes (e .g . , to promote growth o r improve foode f f i c i ency) r ep resen t s an in jud ic ious use o f these impor tan tdrugs . " (See id . a t 16.) S t r i c t adherence to th e 2010 Draf tGuidance would not pe rmi t the subtherapeut ic use of pen i c i l l i n

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i ssuance of the 1977 NOOHs t h a t undermines the or ig ina l f indingst ha t the drugs have not been shown to be sa fe . The FDA/s recentdecis ion to r esc ind the 1977 NOOHs 1 while r e i t e r a t ing i t scontinuing concerns about the safe ty r i sks posed by thesubtherapeut ic uses of i l l i n and t e t r a c yc l ine s 1 does notabsolve the agency of i t s s ta tu tory duty to i n i t i a t e and completewithdrawal proceedings . Am. Pub. Heal th Ass/n v . Veneman l 349F. Supp. 1311 1315-16 (D.D.C. 1972) ( requir ing the FDA to i n i t i a t ewithdrawal proceedings a f t e r f inding t ha t the agencyl s "manyannouncements in the Federal Regis ter regarding FDAconclus ions about the ef f i cacy of var ious drugs" cons t i tu tedf indings under 21 U.S.C. 355(e )1 the human drug coro l la ry to 360b(e)) .

LastlYI the fac t t ha t the FDA " is engaging in o ther ongoing1fregula tory s t r a t eg i e s NOOH Withdrawals 76 Fed. Reg. a t 79 / 698 11

does not re l ieve it of i t s s ta tu tory ob l iga t ion to complete

and t e t racyc l ines . However 1 the 2010 Draf t Guidance merelyprovides recommendations; there are no pena l t i e s fo r l ing toadhere to the 2010 Draf t Guidance. Nonetheless the Draf tGuidance makes c l ea r t ha t in the approval process fo r newNADAs/ANADAs 1 "products t ha t u l t ima te ly move forward towardapproval are those products t ha t inc lude use condi t ions t ha t arecons i s t en t with the guidance and are in tended to minimize theex ten t to which the product use would cont r ibute to [an t ib io tres i s t ance development. 1t (rd. a t 15.) Under the FDA/s cur ren tmodel 1 therefore th e NADAs/ANADAs a t i ssue in t h i s case wouldnot be approved.

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withdrawal proceedings . Upon a f inding t ha t the use of a drugunder cer ta in condi t ions has not been shown to be sa ,360b(e} (1 )presc r ibes a c l e a r course of conduct : i s sue not and anoppor tuni ty fo r a hearing, and, i f the drug sponsor does notdemonstra te t ha t the drug use i s safe a t th e hear ing, withdrawapproval of such use . 1S The s t a t u t e does not empower the agency tochoose a d i f f e r e n t course of act ion in l i eu of withdrawalproceedings, such as t ha t embodied in the 2010 Draf t Guidance.

Pub. Ci t izen . Inc. v. N a t ' l Highway Traf f ic Safety Admin., 374F.3d 1251, 1261 (D.C. Cir . 2004) ("[A]n agency ordered by Congressto promulgate binding regula tory requirements may not i s sue a non-bind ing icy s ta tement tha t encourages but does not compelact ion .") (c i t ing Pub. Ci t izen v . Nuclear 'Regula tory Comm'n, 901F.2d 147, 157 (D.C. Cir . 1990)) i Natura l Res. Def. Council . Inc. v.Envt l . Prot . Agency, 595 F. Supp. 1255, 1261 (S.D.N.Y. 1984) ("Theagency charged with implementing the s t a t u t e i s not f ree to evadethe unambiguous d i rec t ions of the law merely fo r admin is t r a t iveconvenience .") ( in t e rna l quota t ion marks and c i t a t i ons omit ted) .

Accordingly, because th e re sc i s s ion the 1977 NOOHs d id notresc ind the or ig ina l f indings t ha t the subtherapeut ic use of

18 Of course, i f th e drug sponsors demonstra te t ha t the useof the drug i s sa fe , then the Commissioner cannot withdrawapproval .53



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pen ic i l l i n and t e t racyc l ines in food producing animals has not beenshown to be safe , P la in t i f f s ' claim i s not moot.

CONCLUSIONFor the foregoing reasons , P la in t i f f s ' Motion fo r Summary

Judgment on t h e i r f i r s t claim fo r r e l f i s granted and Defendants 'Motion fo r Summary Judgment i s denied. Defendants are herebyordered to i n i t i a t e withdrawal proceedings fo r the r e levan tNADAs / ANADAs . Spec i f ica l ly , the Commissioner of the FDA or theDirector of the CVM must re i ssue a not ice of the proposedwithdrawals (which may be updated) and provide an oppor tuni ty fora hear ing to the re levant drug sponsors ; i f drug sponsors t imelyrequest hear ings and ra i se a genuine and s ubs t a n t i a l i ssue o f fac t ,the FDA must hold a publ ic evident iary hear ing . I f , a t thehearing, th e drug sponsors f a i l to show t ha t use of the drugsi s sa fe , the Commissioner must i ssue a withdrawal order .

The Court notes the l imi t s o f t h i s decis ion . Although theCourt i s order ing th e FDA to complete mandatory withdrawalproceedings the r e levan t pen ic i l l i n and t e t racyc l ineNADAs/ANADAs, the Court i s not order ing a par t i cu la r outcome as tothe f i na l i ssuance of a withdrawal order . I f the drug sponsorsdemonstra te t ha t the subtherapeut ic use of pen ic i l l i n and/ort e t racyc l ines i s safe , then the Commissioner cannot withdraw

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approval . 19So Ordered.

THEODORE H. KATZUNITED STATES MAGISTRATE

Dated: March 22, 2012 New York, New York

19 At ora l argument, both par t i e s agreed t h a t add i t iona lbr ie f ing i s necessary on th e i s sue of a t ime- l fo r hold ing ahear ing and i s su ing a f i na l dec i s ion in the mat ter .Transcr ip t a t 10. )


Opinion and order granting summary judgment re growth promoter antibiotics

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