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SUP Pharmaceutical Distributors Association Vol by FDADocs

VIEWS: 22 PAGES: 6

									                 p._....p_,.. R
                    I.. &
                 MARBURY
                 RUDNICK
                &WOLFE           LLP


                                                                 ,i ,, -:        ..              ,..
                                                                 I ".. t'       i:    ._ /:-   <..I.      +lPkIdNY   L. YOUNG
                                                                                                                 I
  1200 Nineteenth Street, N.W.
  Washington, D.C. 20036-2412                                                                             anthony.young@piperrudnick.com
  www.piperrudnick.com                                                                                    PHONE (202) 861-3882
                                                                                                          FAX     (202) 223-2085
  PHONE (202) 861-3900
  FAX   (202) 223-2085




                                                                 July 24,200l




               Dockets Management Branch (HFA-305)
               Food and Drug Administration
               5630 Fishers Lane
               Room 1061
               Rockville, MD 20857

                         Re:      Docket Nos. 92N-0927 and 88N-0258

               To Whom It May Concern:

                    Please file the enclosed letter in the above-captioned                                      docket.         Thank you
              very much.




                                                                            Pharmaceuti                al Dist,fibutors Association
              ALY/je k                                                                 f
              Enclosure




CHICAGO      1 WASHINGTON         I    BALTIMORE   I   NEWYORK        1     PHILADELPHIA          1 TAMPA       1 DALLAS        1 RESTON    j   LOSANGELES
                   PIPER
                   MARBURY
                   RUDNICK
                                 I)
                   & W 0 L F E 1.1

                                                                                                ANTHONY L. YOUNG
                                                          A ‘i’        ‘.                ‘^.      , ..T L
 1200 Nineteenth Street, N.W.                             (     /“/                                 .
                                                                 ..:     ”                      anthony.young@piperrudnick.com
 Washington, D.C. 20036-2412
 www.piperrudnick.com                                                                           PHONE (202) 861-3882
                                                                                                FAX   (202) 223-2085
 PHONE    (202) 861-3900
 FAX      (202) 223-2085




                                                        July 24, 2001



               REGULAR          MAIL



               Ms. Jane S. Axelrad
               Associate Director for Policy
               Center for Drug Evaluation and Research
               Food and Drug Administration   (HFD-5)

               Seth S. Ray, Esq.
               Associate Chief Counsel for Drugs
               Office of the Chief Counsel
               Food and Drug Administration (GCF-1)
               5600 Fishers Lane
               Rockville, MD 20857


                                 RE:      PDMA Wholesale        Distribution           Regulations

               Dear Ms. Axelrad and Mr. Ray:

                     This is a follow-up to the Petition for Stay that was filed July 12, 2001 by
               the Pharmaceutical       Distributors   Association   (PDA)    with the Dockets
               Management Branch in Docket Nos. 92N-0927 and 88N-0258.                  Enclosed
               herewith is a copy of the July 20, 2001 letter sent by the below listed trade
               associations to the Acting Principal Deputy Commissioner in support of the
               PDA’s request for a stay:

                                 American Pharmaceutical Association
                                 American Veterinary Distributors Association
                                 Food Marketing Institute




CHICAGO        I    BALTIMORE     1    WASHINGTON   I   NEW   YORK           1   PHILADELPHIA          1   TAMPA       1   DALLAS   (   REST0   N
 PIPER
 MARBURY
 RUDNICK                                                          Ms. Jane S. Axelrad
 &WOLFE           ;LP                                               Seth S. Ray, Esq.
                                                                        July 24, 2001
                                                                              Page 2



                   Health Industry Distributors Association
                   International Academy of Compounding Pharmacists
                   National Community Pharmacists Association
                   National Association of Chain Drug Stores
                   Healthcare Distribution Management Association




ALYlj k




WASH1:3552339:1:7/24/01
26242-2
    JUL.23.2001   11:29QM           HOLCH
                            MCGUINESS                                      NO.123    P.2/3




/                                          July20,200l
/                    k
           or. Bernard Schwetz,D.VM, Phl3.
           ActingP&cipalDeputy#mmiSioner
           U.S.PaodandDrugAdministration
           5600       Lime
                Fishers
           Roohie, MI.220857
           DearDr. scbwetz;
                  ThetradeI& professional   ~sociations whose              have
                                                              representatives aipd onthe
                    page          to
           signature attached thislettera.m                       their          fpr
                                                  writingto express smg support the
           Petitionfor a continuationofthe stayin the&x&c dateof theFoodandDrug
                            Final                       Drug           AQt
           Adrninistratiorl’s RuleonthePrescription Marketing (pI)MA) rclatiye        to
           two partic~ku wholesale
                          drug          promions.ThePetitkx MS filedbythePhannaceubcal
           DistributorsA6i!xbtion onJuly12,2001.
                                    of                             wouldprovide
                  A further extension theefktive date thisregulation
                                                     of                       the
                     wkh                   to
           Congress thetimemcegaary complete                      of
                                                      considerationlegislationdes@ed  to
                         two
           modi these whole$ale                 H.R.
                                       provisions. 68 andS. 1132,        have produced
                                                                    which been
                         and
           in theHouse theSenate                  have over
                                       respectiuely, weI1 60 sponsors            them,
                                                                          betwearr
                              of
           whichis reflective theserious          that            is
                                          attention theCongress direoting   towardthis
                                     the              date,
           matter, Howemr,uuder ~urmt effective theCongress                  cam& complete
                                                                       clearly
           legislative      in
                      action timeto prevent           of           frozn
                                             thousands diitributors liquidating their
           inventories, which will become          unsaleable theFDARule.
                                         practically        under
                         the
                   Smce EDAhasrecently            to          that         lacks
                                          reported theCangress theagency the
                          to
           legala~~thority make                  in      Rule, Conwssmustenact
                                &nificantchanges its Final   the                 new
                             the           from      out                  of
           Iegislation prevent regulation driving of butieasthousands small
                      to
                                  impacting operations many
           distriiutorsandnegatively         the        of              wholesaW*
                                                              otherlarger
                               of ti@caut health Sasety
                  Wem unaware arry               or     con- thatwouldarisefrom
                         in                these           wbkh
           a fbrtherdelay thenJesimplementing two provisions, wereoriginally
                   into
           enacted law0~ 13years    ago.
                      you                 of
                  Thank $x yourconsideraliw thisrequest.
JuL.23.2001   11:30RM      I NESSHOLCH
                        MCGU             NO.123   P.3/3

								
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