DEPARTMENT 03 HFALTH & HUMAN SERVICESI,~^_ _.i.~.I”Ix--,~.l.--II.“I.X1-1__lXll _.-._.,~ -I”- “-1 ,,I ..“X_ ““..“.“_.I “_“,^.._,_...
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Food and Drug AdministrationRockville MD 20857
Katherine M. Sanzo, Esq.Lawrence S. Ganslaw, Esq.Morgan, Lewis & Bockius, LLP1111 Pennsylvania Avenue, N. W.Wz#ington, DC 20004Jeffrey B. Chasnow, EsqPfizer Inc.235 Ehst 42nd StreetNew York, NY 10017Stephan E., Lawton, Esq.Gillian R. Woollett, Ph.D.Vice President and Regulatory AffairsBiotechnology Industry Organization (BIO)suite 4001225 I Street, N.W.Washington, DC 20005William R. Rakoczy, Esq.Lord, Bissell & Brook LLP115 South Lx&the StreetChicago, IL 60603Re: Dockets Nos. 2001P-0323/CPl& C5,2002P-0447KP1, and 2003P-0408KPlDear Petitioners:This letter is a consolidated response to the citizen petitions in the dockets referred to above andcomments submitted on the petitions.’Although each of these petitions has a slightly differentfocus and concerns different drug products or classes of products, each is, in essence, a challengeto the Food and Drug Administration’s (FDA’s) interpretation of section 505(b)(2) of the FederalFood, Drug, and Cosmetic Act (the FDCA or the Act)(21 U.S.C. 355(b)(2)).For the reasons
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’ 2001P-0323KPl submittedby Morgan Lewis 0 Bockius, LLP, on behalf of Pfvler Inc. and PharmaciaCorporation 2001 Pfizer petition); 2OOlCP-0323/(X ubmittedby the Biotechnology ndustry Organization BIO)(BIO petition); 2002P-0447/CPlsubmitted y Morgan, Lewis & Bock& LLP on behalf of Pfizer Inc. (2002 Pfizerpetition); 2003P-0408/CPl,submittedby Lord, Bissell & Brook LLP on behalf of TorPharm TorPharmpetition).
The BIO petition contains egulatoryand egal arguments hallengingFDA’s implementationof section 505(b)(2) of
the FDCA, as well as scientific and echnicalarguments s o why biologically derived products, n particular, arenot suited or approvalunder section505(b)(2).This response ddresseshe egal and regulatory ssues; he uniquescientific ssuesassociated ith biologically derivedproductspresenta separate et of challengeshat will be
addressedn a responseo be issued ater.The BIO petition, althoughdesignated citizen petition by RIO, wasdocketedas a comment. FDA is responding o the document s a petition, The 2002 Pfizer petition containsscientific arguments pecific o a pendingapplication.Becausehis application s not approved,FDA
commenton the scientific issues aised n this petition.(gee 2 1 CFR 314.430.)