Pharmaey Compounding subject to FDAApprovaI?t/

The Facts Just Dod

The view recentlyespoused by the FDA is thatcompounding has beenillegal ever since the FederalFood, Drug, and Cosmetic(FDC) Act was passed in19?8. The compoundingprofession disagrees, and thefacts concur. The issue iscoming to a head inlitigation in Texas. There,the courts will decidewhether, as FDA says,every pharmacist who hascompounded since l93Bhas committed a criminalact each time he or shehas compounded, orwhether Congressnever intended tocriminalize the act ofcompounding to fill prescriptionswritten by physicians.

FDAs lengthy legal briefs can beboiled down to a very simpleargument: that every compoundeddrug is an unapproveci new drug.FDAs argument primarily hingeson one statutorv provision.

thisprovision

defines a new drug as"any" drug that is not generallyrecognized as safe and effective byexperts. FDA argues that theword "any" is clear, simple, andunambiguous, and precludesexamining any historical facts.

The problem with FDAsargument is that the courts

pVhave repeatedly reiected it.

]ust recently, the U.S.Supreme Court reviewed a

federal statute thatimposed restrictionson individuals who

had been convicted by"any" court. The government

arsued there, as the FDAargues here, that "any"

means "every" and there areno exceptions. The SupremeCourt rejected thegovernment's argument inthat case, ruling that a

Japanese court was not "any"

court for purposes ofinterpreting the law. In otherwords, the Court said that

courts should not read the word"any" literally as meaning each andevery, and should not ignore, asthe government wanted, Congress'objectives and the historicalcontext.

This is not a new concept. TheSupreme Court in this decision

This is not a new

concept, The Supreme

Court in this decision

cited another, nearly

2}}-year-old Supreme

Court decision involving

the word "any," Thus,

FDAs central argument

about how statutes

must be interpreted -

that the phrase "any

drug" means every

single drug, without

qualification - flies in

the face of ludicialprecedent going back

two centuries.

cited another, nearly 2O0-year-oldSupreme Court decision involvingthe word "any," Thus, FDAscentral argument about howstatutes must be interpreted - thatthe phrase "any drug" means everysingle drug, without qualification -

flies in the face of ;udicialprecedent going back twocenturies.

FDA has cited no facts to supportits position. Instead, FDA reliescompletely on this statutoryargument. However, the factsrefute FDAs view,

Ilt0T: L:i31il::1.the FDC Act, hundreds of millionsof medications were compoundedannually. In fact, the health caresystem could not have functionedwithout compounded drugs, Asthe executive director of theMissouri Board of Pharmacy statedbefore Congress In200V, "In fact,until after World War II whendrug manufacturing became moreprominent, compounding was oneof the principal practices used toprovide needed drugs to patients."FDAs interpretation of the lawwould have meant acomplete breakdown inthe delivery ofhealth care inthe UnitedStates inr9)8,whenCongresspassed thelaw

rl ^t ,\rll The legislative

Ititt, I': il;"'y orthe FDCAct shows that Congress did notintend to interfere with thepractice of medicine. Deprivingphysicians and patients of accessto compounded drugs at a timewhen there were no alternativesfor most diseases would havecaused an extraordinarydisruption with medical practice,and would have been contrary toCongress' intent,

II.l 4\flt There is absolutelyI/ttr'I'l "" i"anation fromthe legislative history that anyonein Congress expected or intendedfor the FDC Act to turncompounding pharmacists intocriminals, FDA says that thissilence shows that Congress didnot intend to confer an exemptionupon pharmacists. In fact, thecontrary was true - no expressedexemption was needed becausenobody ever contemplated thatcompounding would be deemedillegal, Compounding had beenpracticed since the early colonialdays. Under FDAs theory,Congress fundamentally changedthe health care delivery systemwithout anyone in Congresssaying, or even hinting, that theyhad just abolished compoundingas a lawful activity.

II.|4Xlll As of.7978, everyil/tt, I: ;,;" permitted

compounding. Pharmacists weretrained and licensed to

compound in every state.These state laws did not

change after passage of

the FDC Act,Compounding remaineda state-sanctioned, state-licensed activity.Under FDAs theory,every state was authorizingpharmacists to - and often evenrequiring pharmacists to - commitillegal acts.

; { 'd tr In 1938, pharmacy3* i schools t ra ined

pharmacists to compound. UnderFDAs theory, these schools ofpharmacy were teaching - andhave continued to teach - illeealconduct.

d, ' ,* 3 . The PharmacYI 'ffi tr groups were among

the strongest supporters of theFDC Act, The President of theAmerican Pharmacists Association(APhA) was persistent insupporting the bill, and praisedCongress for passing the law. Infact, pharmacy groups wanted thelaw passed because they werealready heavily reguiated, andtheir competitors - drugmanufacturers - were not, UnderFDAs theory, the pharmacygroups were supporting legislationthat deemed virtually everypharmacist in the United Statescriminals,

ffi},iffi d'qtrffiii- The United States';iKIS ", ,ffi" ,n, Pharmacopeia

(USP) contained monographs forcompounded drugs in 1938. Infact, Congress gave the USP specialstatus under the FDC Act, UnderFDAs theory, the USP monographsfor compounded drugs established

criteria for illegalproducts. In fact,

since 19?8, the USPhas added

monographs for newcompounded drugs, and

more recently, standards forcompounding, Under FDAstheory, each new monograph hasrepresented another formula foranother illegal product.

t, " g '" S The United States

1 $4 I sovernmenthaslong engaged in the act ofcompounding. Documents fromthe early 1940s give militarypharmacists instructions oncompounding. The Department ofDefense has continued to supportand utilize compounding. Inearlier litigation, we obtainedcopies of the formulas used byU.S. Army pharmacists forcompounding drugs from bulk.Under FDAs theory, everymilitary pharmacist whocompounds is breakingfederal law. This wouldcreate a terrible dilemmafor military pharmacists -

filling an order to compound adrug would mean to follow anillegal order.

1938 that compounding was illegal.There is no evidence whatsoeverthat FDA, in the wake of thepassage of the law, toldpharmacists that their behaviorwas illegal, In fact, in subsequentpublications for pharmaciststalking about the FDC Act, FDAdescribed multiple provisions ofthe law, but did not tellpharmacists that one effect of thelaw was that compounding hadbecome unlawful,

; .1" u ; ' ' { l W There is no$ ' f r h $

" c o n t e m p o r a n e o u s

evidence that anyone thought thatcompounded drugs would becomeillegal new drugs as a result of the1938 FDC Act. No one inCongress, no one from FDA, nopharmacist,and no

witnessesbefore Congressever said orsuggested such a thing. UnderFDAs theory, the U.S. health caresystem was being transformed,and nobody ever said a wordabout it. FDA has argued in itsbrief that Congress passed the lawto give FDA the discretion toregulate compounding. In fact,

$- E .g -,$tu The federale . R.€, ,& * government

provides reimbursement coveragefor compounded medications.Under FDAs theory, the U.S.Government is paying for anillegal product.

ffil q g o1$ rhe FDA itself did$' * * 1 not take the view in

there is no evidence at all thatCongress or anyone else thought itwas conferring upon FDA anyauthority over compounding. Noris there any evidence thatCongress intended forcompounding to survive solely atthe discretion of FDA.

ft,l t\tll In 1970, Congressl ( / t r I " 1 ' r ___ -l r r l ) . . o a s s e d a l a w- - - ! r - r r - - -

regulating controlled substances.It gave an exemption forcompounding pharmacists undercertain circumstances. The U.S,Drug Enforcement Administration's(DEA) implementing regulationsalso gave compounding pharmacistsan exemption. Under FDAstheory, Congress outlawedcompounding in 1938 and then in1970 exempted this illegalbehavior from certain provisionsof the DEA laws. There is noevidence that in 1970 Congressconsidered compounding to beanything other than a lawful,medically necessary practice.

tltCT: :."#illliffin*,in the retail setting, in hospitals,and elsewhere. There is nodisputing - even by FDA itself -

that compounding remainsmedically essential. Under FDAstheory, compounding pharmacists

who perform this essential, life-supporting service have beencriminals since 1938, protectedfrom prosecution only by FDAswillingness to exercise itsenforcement discretion.

IIICT: :.::liiHil',not take the position that allcompounded drugs wereunapproved new drugs, andtherefore illegal. In fact, FDA didnot espouse this theory until morethan five decades after the lawwas passed. If, as FDA nowargues, the plain language of thestatute makes it crystal clear thatevery compounded drug is illegal,one would have expected FDA tohave articulated this theory wellbefore a half century elapsed.

FDA has no facts to support itsposition, When Congress passedthe FDC Act in 1938, nobody -

Congress, pharmacists, statelegislatures, state Boards ofPharmacy, USP, the U,S, Military,or FDA - thought that Congresshad banned compounding.Nobody said a word about thisdramatic shift in health policy. Itwas not until 50 years later thatFDA reinterpreted the law to saythat a linchpin of the health caresystem was a criminal act.

The courts have developedprinciples for interpreting this typeof silence. In a less legalistic way,so did Sir Arthur Conan Doyle. Inhis famous story Silver Blaze, thefollowing exchange took place:

Colonel Ross: "Is there any otherpoint to which you would wish todraw my attention?"

Holmes: "'To the curious incidentof the dog in the night-time."

Colonel Ross: "The dog didnothing in the night-time."

Holmes: "That was the curiousincident."

The utter silence regarding anyintent to ban compounding,combined with massiveaccumulation of facts rebuttingFDAs newly minted theory, showsthat FDAs interpretation is simplywrong and would keep millions ofpatients from receiving essentialtreatment. For these patients withunique needs that are unmet byoff-the-shelf pharmaceuticals,compounded medicines -

prescribed or ordered by licensedphysicians and mixed by trained,licensed compounding pharmacists- are the safest and most effectiveway to better health.

PINTERNAIIONAI ACADEMY OF@MFOT]NDING PHARMACISTS

PO Box 1365, Sugar Land,TX77478Voice: 281-933-8400 . Fax: 281-495-0602 . wwv.iacprx.org