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Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Timely Review and Increased Access
to Affordable Drugs Act''.

SEC. 2. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD.

(a) In General.--Section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)) is amended--
(1) in paragraph (2)(A)(vii)--
(A) by striking ''a certification, the opinion of
the applicant and to the best of his knowledge,'' and
inserting ''a certification that, in the opinion of and
to the best knowledge of the applicant,''; and
(B) by inserting after ''each patent'' the
following: ''published by the Secretary under
subsection (c)(2) at least 1 day before the date on
which the application is filed''; and
(2) in paragraph (5)--
(A) in subparagraph (B)(iii)--
(i) by inserting after ''of a patent'' the
following: ''published by the Secretary under
subsection (c)(2) at least 1 day before the
date on which the application is filed'';
(ii) by striking ''paragraph (2)(B)(i)''
each place it appears and inserting ''(2)(B)'';
and
(iii) by adding at the end the following:
''If, in connection with an application for
approval of a drug under this subsection, the
applicant provides an owner of a patent notice
under paragraph (2)(B) with respect to the
patent, and the owner of the patent fails to
bring a civil action against the applicant for
infringement of the patent on or before the
date that is 45 days after the date on which
the notice is received, the owner of the patent
shall be barred from bringing a civil action
against the applicant with respect to the
application.'';
(B) by redesignating subparagraphs (C) and (D) as
subparagraphs (E) and (F), respectively; and
(C) by inserting after subparagraph (B) the
following:
''(C) Availability of 30-month period.--
''(i) In general.--The 30-month period
provided under subparagraph (B)(iii) shall be
available only with respect to patents
published by the Secretary under subsection
(c)(2) at least 1 day before the date on which
the application is filed.
''(ii) Amendment of application.--If an
application is amended to include a
certification described in paragraph
(2)(A)(vii)(IV), the 30-month period provided
under subparagraph (B)(iii) shall be available
with respect to the patent concerning which the
certification was made.
''(iii) Subsequent patents.--
''(I) Separate application.--Any
patent published by the Secretary under
subsection (c)(2) subsequent to the
filing date but before approval of an
application under this paragraph shall
be addressed in a subsequent
application if the subsequent applicant
makes a certification described in
subparagraph (2)(A)(vii)(IV) with
respect to the patent, in which case
the 30-month period provided under
subparagraph (B)(iii) shall be
available to the subsequently published
patent.
''(II) Referencing information in
the previous application.--If a
subsequent application is filed, the
Secretary shall permit the applicant,
to the extent that the Secretary
determines it to be appropriate, to
reference information submitted in the
previous application.''.
(b) Conforming Amendments.--Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) is amended--
(1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by
striking ''(j)(5)(D)(ii)'' each place it appears and inserting
''(j)(5)(F)(ii)'';
(2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by
striking ''(j)(5)(D)'' each place it appears and inserting
''(j)(5)(F)''; and
(3) in subsections (e) and (l), by striking
''505(j)(5)(D)'' each place it appears and inserting
''505(j)(5)(F)''.

SEC. 3. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(5)) (as amended by section 2) is amended--
(1) in subparagraph (B)(iv), by striking subclause (II) and
inserting the following:
''(II) the earlier of--
''(aa) the date of a final
decision of a court in a civil
action described in clause
(iii) from which no appeal has
been or can be taken; or
''(bb) the date of a
settlement order or consent
decree signed by a Federal
judge that enters a final
judgment and includes a finding
that the patent that is the
subject of the certification is
invalid or not otherwise
infringed;''; and
(2) by inserting after subparagraph (C) the following:
''(D) Forfeiture of 180-day exclusivity period.--
''(i) In general.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited if the applicant--
''(I) fails to market the drug
within 30 days after the date on which
the approval of the application for the
drug is made effective under
subparagraph (B)(iii);
''(II) fails to market the drug--
''(aa) within 30 days after
the date of a final decision of
a court or the date of a
settlement order or consent
decree in a civil action
described in subparagraph
(B)(iii); or
''(bb) if the application
has not been approved before
the date of such a decision,
within 30 days after the date
of approval of the application;
''(III) withdraws the application;
''(IV) amends the application from
a certification under paragraph
(2)(A)(vii)(IV) to a certification
under paragraph (2)(A)(vii)(III);
''(V) fails to get tentative
approval of the application within 30
months after the date on which the
application is filed, if the failure is
not caused by a change in the
requirements for tentative approval of
the application imposed after the date
on which the application is filed; or
''(VI) enters into an agreement
with the owner of the patent--
''(aa) that is the subject
of the certification under
paragraph (2)(A)(vii)(IV); and
''(bb) that the Federal
Trade Commission determines has
violated the antitrust laws (as
defined in section 1 of the
Clayton Act (15 U.S.C. 12),
except that the term includes
section 5 of the Federal Trade
Commission Act (15 U.S.C. 45)
to the extent that that section
applies to unfair methods of
competition).
''(ii) Subsequent applicant.--If an
applicant forfeits the 180-day exclusivity
period under clause (i)--
''(I) a subsequent application
containing a certification period
described in paragraph (2)(A)(vii)(IV)
shall become effective immediately on
approval; and
''(II) the subsequent applicant
shall not be eligible for a 180-day
exclusivity period under subparagraph
(B)(iv).''.

SEC. 4. BIOEQUIVALENCE.

(a) In General.--The amendments to part 320 of title 21, Code of
Federal Regulations, promulgated by the Commissioner of Food and Drugs
on July 17, 1991 (57 Fed. Reg. 17997 (April 28, 1992)), shall continue
in effect as an exercise of authorities under sections 501, 502, 505,
and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351,
352, 355, 371).
(b) Effect.--Subsection (a) does not affect the authority of the
Commissioner of Food and Drugs to amend part 320 of title 21, Code of
Federal Regulations.

SEC. 5. OVER-THE-COUNTER DRUGS.

Section 503(b)(3) the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(b)(3)) is amended--
(1) by striking ''(3) The Secretary may by regulation
remove drugs'' and inserting the following:
''(3) Removal of certain drugs from requirements of
paragraph (1).--
''(A) In general.--The Secretary may by regulation
remove a drug''; and
(2) by adding at the end the following:
''(B) Misbranding.--A drug that is removed from the
requirements of paragraph (1) under subparagraph (A)
shall be deemed to be misbranded under paragraph (1) in
a case in which any person introduces the drug into
interstate commerce in accordance with the requirements
of paragraph (1).''.
A:
Timely Review and Increased Access to Affordable Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning the timing of generic drug availability.Prohibits (for subsequently issued patents) an extension of the 30 month stay of Food and Drug Administration (FDA) approval for any new drug where an abbreviated new drug application (ANDA) contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer.Requires the first generic applicant (ANDA) with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors which delay or prevent the marketing of the generic drug, including failure to market and agreements with the patent holder which violate the antitrust laws.Continues current regulations concerning bioeqiovalence.States that drugs which no longer require a prescription (over-the-counter) but that are sold as if they did are deemed misbranded (mislabeled and subject to seizure).