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FDA interpretation of 505(b)(2) NDA

FDA interpretation of 505(b)(2) NDA

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Published by Shilpa Kotian
FDA's October 14, 2003 response to a number of Citizen petitions challenging the agency interpretation of the 505(b)(2)NDA statutory provision explaining the background and applicability of the section
FDA's October 14, 2003 response to a number of Citizen petitions challenging the agency interpretation of the 505(b)(2)NDA statutory provision explaining the background and applicability of the section

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Categories:Types, Letters
Published by: Shilpa Kotian on Mar 27, 2012
Copyright:Attribution Non-commercial


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DEPARTMENT 03 HFALTH & HUMAN SERVICESI,~^_ _.i.~.I”Ix--,~.l.--II.“I.X1-1__lXll _.-._.,~ -I”- “-1 ,,I ..“X_ ““..“.“_.I “_“,^.._,_... ” ” .,,._.,.,”l”-“.” _” I” ““~,xI_ .l”“l”__” “ll _^I “_” ” ,,xxx”I”..“II
October 14,2003
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
-s.e.e*--maaxa ,.-- *_1.,, “,x-MM<-“,_ ,I,,,_
’ 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.)
Docket Nos. 2001P-0323/CPl & C5,2002P-0447/CpI, and 2003P-0408KPldescribed below, FDA declines to alter its current interpretation of section 505(b)(2).Accordingly, those portions of the petitions seeking such a change are denied.’ However, theAgency also grants certain specific portions of the petitions as described below (section IV-M)related to therapeutic equivalence ratings for 505(b)(2) drug products.I.INTRODUCTIONSection 505(b)(2) of the Act was enacted as part of the Drug Price Competition and Patent TermRestoration Act of 1984 (the Hatch-Waxman Amendments).Section 505(b)(2) provides:An application [may be] submittedunder
section 505(b)(l)] for which the
[safety and effectiveness] nvestigations . , relied upon by the applicant tosupport] approval of the application
were not conducted by or for the applicant
and for which the applicanthas not obtaineda right
of referenceor use from theperson by or for whom the investigations were conducted (and] shall also include[patent certifications for patents on the drug for which investigations wereconducted or a method of use statement].
The Hatch-Waxman Amendments reff ect Congress’s attempt to balance the need to encourageinnovation with the desire to speed he availability of lower cost alternatives to approved drugs.(S&eEli Lilly and Co. v. Medtronic, Inc., 496 U.S. 66 1 (1990); and Bristol-Myers Squibb%ompany ‘v. Royce Laboratories, Inc., 69 F.3d 1130,1132,1133-34 (Fed. Cir. 1995).) Withpassage of the Hatch- Waxman Amendments, the Act describes different routes for obtainingapproval of two broad categories of drug applications: new drug applications (NDAs), for whichthe requirements are set out in section 505(b) and (c) of the Act, and abbreviated new drugapplications (ANDAs), for which the requirements are set out in section 505(j). These categoriescan be further subdivided into the following:
an application that contains fi.dl reports of investigations of safety and effectivenessthat were conducted by or for the applicant or for which the applicant has a right ofreference (section 505(b)(l)) (a stand alone NDA);.an application that contains full reports of investigations of safety and electiveness,where at least some of the information required for approval comes from studies notconducted by or for the applicant and for which the applicant has not obtained a rightof reference (section 505(b)(2)) (a 505(b)(2) application);0 an application for a duplicate3 of a previously approved drug that containsinformation to show that the proposed product is identical in active ingredient(s),dosage form, streng& route of administration, labeling, quality, performance
2 As discussed in greater detail in section 1V.N below, FDA is considering whether to commence a public process toexamine the narrow question of whether to change our interpretation of section SOS(b)(Z)as it applies to applicationsfor which the only change from the listed drug is a change in active ingredient.3 The informal term duplkute is used in this respokse to
o an application under section 505(i) describing aproduct that is the same as the listed drug with respect to active ingredient, dosage form, route of administration,strength, and conditions of use, among other characteristics.

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