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DEPAITMENT OF
... HEALTH HUMAN
SEaVK:ES
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Via F8csimUe aDd U.S. MaU G. Anthony Howard President CanaRxServices. ~. P.O. Box 21086 T~eh.ONN8N4S1 Canada Via .~8CSi8ik..4 FedenJ [xpress Joseph Todd,Jr. K. RegionalManager
CanaRx Services. II¥:. SIO S. Haltl~ Dr. SyracU8C. 46567 IN
Re:
C.a.RI SeI'Vica. (.CHaRs8. lac.
DearMessrs. HowardandT~: We havereviewedCanaR,x's response the warningletter that it ~tly to receivedfrom the U.S. Fo
(MMEDS Act") and questions why tile Secmary of Health and Hwnan Services(8HHS1 bas 1M)(
madedie written ca1iflCationto Corlgral that is necessary triggerthe law wxIcr 21 U.S.C. to § 384(1).Section384(1)is intended safeguard public heald\. Und« that provision,the to the Secretary cannotmakethe necessary fication unless candemonstrate COI~ certi he to tJw ~lementation of die MEDS Act -Mil (I) pose00 ~tional risk to die public'shealdl81d safety.Utd (2) result in a significantreductionin thecostof oovercdproductsto the American cooswner.821 U.S.C.§ 384(1). As the response letternotes,in. January 2001letterto Senator JunesJeffords,HHS S-cadaryTommy~pIOn expl8iDCd be could DOt why maketheSection384(1) certification. His reasons includedthe dangerdaat, implemented, MEDS Act, would .pose. greater if d1e public healthrisk thanwe facetoday,-uxI would resultin .. lossofcon fidaM:eby Americans in the safetyof our drug supply.- Notably,Scadary 1'tk)II1psoD'S filMtings re-aftinnedthedecision that then-Secretary DonnaShalalamadein 2000whenshealsoconcluded the standards that set forth in Section804(1) werenot met.
PageS - Mesas. HowardaM Todd countersthat specialconsideration shouldbegiven to its operationslndto CIi8J op«aton lite it. This IIgwnent ignoresthe ~uiraneats of die Food.DnI& CosmeticAct, which is intendedto assure safetyof the drop usedby Americans.Moreover, the die MEDS Act doesIM>t limit drug importsto Caod, but w