A bill to amend the Federal Food, Drug, and Cosmetic Act to establish therapeutic equivalence requirements for generic drugs, and for other purposes

4 Pages·1999·0.16 MB·English

by  United States. Congress. House

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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-
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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)
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1 any requirement which is different from, or in addition
2 to,anyrequirementrelatedtotherapeuticequivalenceap-
3 pUcableunderparagraph(5)(A)(ii)tothedrug.".
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