TIONS.—Section 505(b)(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)(2)) is amended—
(1) in subparagraph (A)—
(A) in the matter preceding clause (i), by
striking ‘‘the drug for which such investigations
were conducted or which claims a use for such
drug for which the applicant is seeking approval
under this subsection’’ and inserting ‘‘an active
ingredient of the drug for which such investiga-
tions were conducted, alone or in combination
with another active ingredient or which claims
the first approved use for such drug for which
the applicant is seeking approval under this
subsection’’; and
(B) in clause (iv), by striking ‘‘; and’’ and
inserting a period;
(2) in the matter preceding subparagraph (A),
by striking ‘‘shall also include—’’ and all that fol-
lows through ‘‘a certification’’ and inserting ‘‘shall
also include a certification’’;
(3) by striking subparagraph (B); and
(4) by redesignating clauses (i) through (iv) as
subparagraphs (A) through (D), respectively, and
aligning the margins of the subparagraphs with the
margins of subparagraph (A) of section 505(c)(1) of
that Act (21 U.S.C. 355(c)(1)).
(b) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j)(2)(A) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(2)(A)) is amended—
(1) in clause (vi), by striking the semicolon and
inserting ‘‘; and’’; and
(2) in clause (vii)—
(A) in the matter preceding subclause (I),
by striking ‘‘the listed drug referred to in clause
(i) or which claims a use for such listed drug
for which the applicant is seeking approval
under this subsection’’ and inserting ‘‘an active
ingredient of the listed drug referred to in
clause (i), alone or in combination with another
active ingredient or which claims the first ap-
proved use for such drug for which the appli-
cant is seeking approval under this subsection’’;
(B) in subclause (IV), by striking ‘‘; and’’
and inserting a period; and
(C) by striking clause (viii).
(c) EFFECTIVE DATE.—The amendments made by
this section shall only be effective with respect to a listed
drug for which no certification pursuant to section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, Cosmetic
Act was made prior to the date of enactment of this Act.
SEC. 3. CITIZEN PETITION REVIEW.
Section 505(j)(5) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)) is amended—
(1) by redesignating subparagraphs (C) and
(D) as subparagraphs (D) and (E), respectively; and
(2) by inserting after subparagraph (B) the fol-
lowing:
‘‘(C) Notwithstanding any other provision of law, the
submission of a citizen’s petition filed pursuant to section
10.30 of title 21, Code of Federal Regulations, with re-
spect to an application submitted under paragraph (2)(A),
shall not cause the Secretary to delay review and approval
of such application, unless such petition demonstrates
through substantial scientific proof that approval of such
application would pose a threat to public health and safe-
ty.’’.
SEC. 4. BIOEQUIVALENCE TESTING METHODS.
Section 505(j)(8)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(8)(B)) is amended—
(1) in clause (i), by striking ‘‘or’’ at the end;
(2) in clause (ii), by striking the period and in-
serting ‘‘; or’’; and
(3) by adding at the end the following:
‘‘(iii) the effects of the drug and the listed
drug do not show a significant difference based
on tests (other than tests that assess rate and
extent of absorption), including comparative
pharmacodynamic studies, limited confirmation
studies, or in vitro methods, that demonstrate
that no significant differences in therapeutic ef-
fects of active or inactive ingredients are ex-
pected.’’.
SEC. 5. ACCELERATED GENERIC DRUG COMPETITION.
(a) IN GENERAL.—Section 505(j)(5) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is
amended—
(1) in subparagraph (B)(iv), by striking sub-
clause (II) and inserting the following:
‘‘(II) the date of a final decision of a court
in an action described in clause (ii) from which
no appeal can or has been taken, or the date of
a settlement order or consent decree signed by
a Federal judge, that enters a final judgement,
and includes a finding that the relevant patents
that are the subject of the certification involved
are invalid or not infringed, whichever is ear-
lier,’’;
(2) by redesignating subparagraphs (C) and
(D) as subparagraphs (D) and (E), respectively; and
(3) by inserting after subparagraph (B), the
following:
‘‘(C) The one-hundred and eighty day period de-
scribed in subparagraph (B)(iv) shall become available to
the next applicant submitting an application containing a
certification described in paragraph (2)(A)(vii)(IV) if the
previous applicant fails to commence commercial mar-
keting of its drug product once its application is made ef-
fective, withdraws its application, or amends the certifi-
cation from a certification under subclause (IV) to a cer-
tification under subclause (III) of such paragraph, either
voluntarily or as a result of a settlement or defeat in pat-
ent litigation.’’.
(b) EFFECTIVE DATE.—The amendments made by
this section shall only be effective with respect to an appli-
cation filed under section 505(j) of the Federal Food,
Drug, Cosmetic Act for a listed drug for which no certifi-
cation pursuant to 505(j)(2)(A)(vii)(IV) of such Act was
made prior to the date of enactment of this Act.
SEC. 6. SENSE OF CONGRESS.
It is the sense of Congress that measures should be
taken to effectuate the purpose of the Drug Price Com-
petition and Patent Term Restoration Act of 1984 (re-
proval may be made effective on the date cer-
tified under subparagraph (C).’’;
(C) in subparagraph (C), by striking
‘‘clause (iv) of subsection (b)(2)(A)’’ and insert-
ing ‘‘subparagraph (D) of subsection (b)(2)’’;
and
(D) in subparagraph (D)(ii), by striking
‘‘clause (iv) of subsection (b)(2)(A)’’ and insert-
ing ‘‘subparagraph (D) of subsection (b)(2)’’;
and
(3) in subsection (j), in paragraph (2)(A), in
the matter following clause (vii)(IV), by striking
‘‘clauses (i) through (viii)’’ and inserting ‘‘clauses (i)
through (vii)’’.
(b) PEDIATRIC STUDIES OF DRUGS.—Section 505A
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) is amended—
(1) in subsection (a)(2)—
(A) in clause (i) of subparagraph (A), by
striking ‘‘(b)(2)(A)(ii)’’ and inserting ‘‘(b)(2)’’;
(B) in clause (ii) of subparagraph (A), by
striking ‘‘(b)(2)(A)(iii)’’ and inserting ‘‘(b)(2)’’;
and
(C) in subparagraph (B), by striking ‘‘sub-
section (b)(2)(A)(iv)’’ and inserting ‘‘subsection
(b)(2)’’; and
(2) in subsection (c)(2)—
(A) in clause (i) of subparagraph (A), by
striking ‘‘(b)(2)(A)(ii)’’ and inserting ‘‘(b)(2)’’;
(B) in clause (ii) of subparagraph (A), by
striking ‘‘(b)(2)(A)(iii)’’ and inserting ‘‘(b)(2)’’;
and
(C) in subparagraph (B), by striking ‘‘sub-
section (b)(2)(A)(iv)’’ and inserting ‘‘subsection
(b)(2)’’.
(c) DEFINITION.—Section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by
adding at the end the following:
‘‘(kk) For purposes of the references to court deci-
sions in clauses (i) and (iii) of section 505(c)(3)(C) and
clauses (iii)(I), (iii)(III) of section 505(j)(5)(B), the term
‘the court’ means the court that enters final judgment
from which no appeal (not including a writ of certiorari)
can or has been taken.’’.
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