A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure that there is competition in the pharmaceutical industry and increased access to affordable drugs.

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).''.

Summary: 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 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 filingcertification 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 .