l^ui>l/o U-)S BWI/Ho^^l/OU^ Caress/|jfSefS.o^/fW/f.|e,| ICC2M-S07L-i1br3ary 7500SecudtyBivd. iBaltimors, Marylend 21244 106thcongress H. R. 805 1stSession ToamendtheFederalFood,Drug,andCosmeticActtoestablishtherapeutic equivalencerequirementsforgenericdrugs,andforotherpurposes. IN THE HOUSE OF REPRESENTATIVES Februaky23,1999 Mr.Pallone(forhimself,Mr.Berry,Mrs.Clayton,Mr.Shows,Ms.Kil- PATRiCK, Ms. Jackson-Lee ofTexas, Mr. Stark, Ms. Norton, Ms. ScHAKOWSKY,Mr.Rangel,Mr.Weiner,Mr.Waxjian,Mr.Brownof Ohio,Mr.MOAKLEY,Mr.LUTHER,Mr.Nadler,Mr.HiNCHEY,andMr. Allen)introducedthefollowingbill;whichwasreferredtotheCommit- teeonCommerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to establishtherapeuticequivalencerequirementsforgeneric drugs,andforotherpurposes. 1 BeitenactedhytheSenateandHouseofRepresenta- 2 tivesoftheUnitedStatesofAmericainCongressassembled, 3 SECTION1.SHORTTITLE. 4 ThisActmaybecitedasthe"GenericDrugsAccess 5 Actof1999". 6 SEC.2.THERAPEUTICEQUIVALENCE. 7 Section 505(j)(5) of the Federal Food, Drug, and 8 CosmeticAct(21U.S.C.355(j)(5))isamended— — 2 1 (1) by adding at the end ofsubparagraph (A) 2 the following: "Whenthe Seeretar^^ approves an ap- 3 phcation submitted under paragraph (1), the See- 4 retary shall include in such approval a findingthat 5 the drugforwhichthe applicationis approvedis or 6 is not the therapeutic equivalent ofthe listed drug 7 involved."; 8 (2) byinserting "(i)" after "(A)" and by add- 9 ingattheendofsubparagraph(A)thefollowing: 10 "(ii) Forpurposes ofclause (i), adrugisthethera- 11 peutic equivalent of a listed drugwhen, with respect to 12 thelisteddrug 13 "(I) all ofits active ingredients are the same, 14 itisofthesamedosageform, ithasthesameroute 15 ofadministration, it is identical in strength or con- 16 centration, and it meets the same compendial or 17 other apphcable standard, except that it may differ 18 in shape, scoring, configuration, packaging, 19 excipients, expirationtime, or (within the limits es- 20 tablishedbyparagraph(2)(A)(v))labehng; 21 "(n) itisexpectedtohavethesamechnicalef- 22 feetandsafetyprofilewhenadministeredtopatients 23 underconditionsspecifiedinthelabehng;and 24 "(HI) iteitherdoesnotpresentaknownorpo- 25 tentialbioequivalence problem and meets an accept- •HR806EH C2-07-i3 7500S3cu;1tyBlvd. g 5c.ltiinc«rs, Maryiend21244 1 able in vitro standard or ifit does present such a 2 problem, is showntomeetanappropriatebioequiva- 3 lencestandard. 4 "(iii) Ifadrugmeetstherequirementsofclause (ii) 5 with, respectto a hsted drug, the Secretar}^shall include 6 inthe approval ofthe apphcation for the drugthat it is 7 the therapeutic equivalent ofthe hsted drug involved."; 8 and 9 (3) in paragraph (7)(A)(i) by striking in sub- 10 clause(II) "andthenumberoftheapplicationwhich 11 was approved" and inserting the number ofthe 12 apphcationwhichwas approved, and, inthe case of 13 adrugthatisthesubjectofanapphcationapproved 14 underparagraph (5)(A) afterthe date ofthe enact- 15 ment ofthe Generic DrugsAccessAct of 1999, the 16 finding ofthe Secretary that the drug is or is not 17 the therapeutic equivalent of the hsted drug in- 18 volved". 19 SEC.3.STATELAWS. 20 Section 505(j) ofthe FederalFood, Drug, and Cos- 21 meticAct(21U.S.C. 355(j))isamendedbyaddingatthe 22 endthefollowing: 23 "(10)NoStateorpoliticalsubdivisionofaStatemay 24 estabhshorcontinueineffectwithrespecttoadrugthat 25 is the subject of an apphcation under paragraph (5)(A) >HR805IH ensLIBRflRV 4 3 amS 0001DtD4 3 1 any requirement which is different from, or in addition 2 to,anyrequirementrelatedtotherapeuticequivalenceap- 3 pUcableunderparagraph(5)(A)(ii)tothedrug.". O >HR805IH