[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 812 Engrossed in Senate (ES)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
107th CONGRESS
  2d Session
                                 S. 812

_______________________________________________________________________

                                 AN ACT


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

         TITLE I--GREATER ACCESS TO AFFORDABLE PHARMACEUTICALS

SEC. 101. SHORT TITLE.

    This title may be cited as the ``Greater Access to Affordable 
Pharmaceuticals Act of 2002''.

SEC. 102. FINDINGS; PURPOSES.

    (a) Findings.--Congress finds that--
            (1) prescription drug costs are increasing at an alarming 
        rate and are a major worry of American families and senior 
        citizens;
            (2) enhancing competition between generic drug 
        manufacturers and brand-name manufacturers can significantly 
        reduce prescription drug costs for American families;
            (3) the pharmaceutical market has become increasingly 
        competitive during the last decade because of the increasing 
        availability and accessibility of generic pharmaceuticals, but 
        competition must be further stimulated and strengthened;
            (4) the Federal Trade Commission has discovered that there 
        are increasing opportunities for drug companies owning patents 
        on brand-name drugs and generic drug companies to enter into 
        private financial deals in a manner that could restrain trade 
        and greatly reduce competition and increase prescription drug 
        costs for consumers;
            (5) generic pharmaceuticals are approved by the Food and 
        Drug Administration on the basis of scientific testing and 
        other information establishing that pharmaceuticals are 
        therapeutically equivalent to brand-name pharmaceuticals, 
        ensuring consumers a safe, efficacious, and cost-effective 
        alternative to brand-name innovator pharmaceuticals;
            (6) the Congressional Budget Office estimates that--
                    (A) the use of generic pharmaceuticals for brand-
                name pharmaceuticals could save purchasers of 
                pharmaceuticals between $8,000,000,000 and 
                $10,000,000,000 each year; and
                    (B) generic pharmaceuticals cost between 25 percent 
                and 60 percent less than brand-name pharmaceuticals, 
                resulting in an estimated average savings of $15 to $30 
                on each prescription;
            (7) generic pharmaceuticals are widely accepted by 
        consumers and the medical profession, as the market share held 
        by generic pharmaceuticals compared to brand-name 
        pharmaceuticals has more than doubled during the last decade, 
        from approximately 19 percent to 43 percent, according to the 
        Congressional Budget Office;
            (8) expanding access to generic pharmaceuticals can help 
        consumers, especially senior citizens and the uninsured, have 
        access to more affordable prescription drugs;
            (9) Congress should ensure that measures are taken to 
        effectuate the amendments made by the Drug Price Competition 
        and Patent Term Restoration Act of 1984 (98 Stat. 1585) 
        (referred to in this section as the ``Hatch-Waxman Act'') to 
        make generic drugs more accessible, and thus reduce health care 
        costs; and
            (10) it would be in the public interest if patents on drugs 
        for which applications are approved under section 505(c) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) were 
        extended only through the patent extension procedure provided 
        under the Hatch-Waxman Act rather than through the attachment 
        of riders to bills in Congress.
    (b) Purposes.--The purposes of this title are--
            (1) to increase competition, thereby helping all Americans, 
        especially seniors and the uninsured, to have access to more 
        affordable medication; and
            (2) to ensure fair marketplace practices and deter 
        pharmaceutical companies (including generic companies) from 
        engaging in anticompetitive action or actions that tend to 
        unfairly restrain trade.

SEC. 103. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG 
              ADMINISTRATION.

    (a) Filing After Approval of an Application.--
            (1) In General.--Section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) (as amended by section 
        9(a)(2)(B)(ii)) is amended in subsection (c) by striking 
        paragraph (2) and inserting the following:
            ``(2) Patent information.--
                    ``(A) In general.--Not later than the date that is 
                30 days after the date of an order approving an 
                application under subsection (b) (unless the Secretary 
                extends the date because of extraordinary or unusual 
                circumstances), the holder of the application shall 
                file with the Secretary the patent information 
                described in subparagraph (C) with respect to any 
                patent--
                            ``(i)(I) that claims the drug for which the 
                        application was approved; or
                            ``(II) that claims an approved method of 
                        using the drug; and
                            ``(ii) with respect to which a claim of 
                        patent infringement could reasonably be 
                        asserted if a person not licensed by the owner 
                        engaged in the manufacture, use, or sale of the 
                        drug.
                    ``(B) Subsequently issued patents.--In a case in 
                which a patent described in subparagraph (A) is issued 
                after the date of an order approving an application 
                under subsection (b), the holder of the application 
                shall file with the Secretary the patent information 
                described in subparagraph (C) not later than the date 
                that is 30 days after the date on which the patent is 
                issued (unless the Secretary extends the date because 
                of extraordinary or unusual circumstances).
                    ``(C) Patent information.--The patent information 
                required to be filed under subparagraph (A) or (B) 
                includes--
                            ``(i) the patent number;
                            ``(ii) the expiration date of the patent;
                            ``(iii) with respect to each claim of the 
                        patent--
                                    ``(I) whether the patent claims the 
                                drug or claims a method of using the 
                                drug; and
                                    ``(II) whether the claim covers--
                                            ``(aa) a drug substance;
                                            ``(bb) a drug formulation;
                                            ``(cc) a drug composition; 
                                        or
                                            ``(dd) a method of use;
                            ``(iv) if the patent claims a method of 
                        use, the approved use covered by the claim;
                            ``(v) the identity of the owner of the 
                        patent (including the identity of any agent of 
                        the patent owner); and
                            ``(vi) a declaration that the applicant, as 
                        of the date of the filing, has provided 
                        complete and accurate patent information for 
                        all patents described in subparagraph (A).
                    ``(D) Publication.--On filing of patent information 
                required under subparagraph (A) or (B), the Secretary 
                shall--
                            ``(i) immediately publish the information 
                        described in clauses (i) through (iv) of 
                        subparagraph (C); and
                            ``(ii) make the information described in 
                        clauses (v) and (vi) of subparagraph (C) 
                        available to the public on request.
                    ``(E) Civil action for correction or deletion of 
                patent information.--
                            ``(i) In general.--A person that has filed 
                        an application under subsection (b)(2) or (j) 
                        for a drug may bring a civil action against the 
                        holder of the approved application for the drug 
                        seeking an order requiring that the holder of 
                        the application amend the application--
                                    ``(I) to correct patent information 
                                filed under subparagraph (A); or
                                    ``(II) to delete the patent 
                                information in its entirety for the 
                                reason that--
                                            ``(aa) the patent does not 
                                        claim the drug for which the 
                                        application was approved; or
                                            ``(bb) the patent does not 
                                        claim an approved method of 
                                        using the drug.
                            ``(ii) Limitations.--Clause (i) does not 
                        authorize--
                                    ``(I) a civil action to correct 
                                patent information filed under 
                                subparagraph (B); or
                                    ``(II) an award of damages in a 
                                civil action under clause (i).
                    ``(F) No claim for patent infringement.--An owner 
                of a patent with respect to which a holder of an 
                application fails to file information on or before the 
                date required under subparagraph (A) or (B) shall be 
                barred from bringing a civil action for infringement of 
                the patent against a person that--
                            ``(i) has filed an application under 
                        subsection (b)(2) or (j); or
                            ``(ii) manufactures, uses, offers to sell, 
                        or sells a drug approved under an application 
                        under subsection (b)(2) or (j).''.
            (2) Transition provision.--
                    (A) Filing of patent information.--Each holder of 
                an application for approval of a new drug under section 
                505(b) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(b)) that has been approved before the date 
                of enactment of this Act shall amend the application to 
                include the patent information required under the 
                amendment made by paragraph (1) not later than the date 
                that is 30 days after the date of enactment of this Act 
                (unless the Secretary of Health and Human Services 
                extends the date because of extraordinary or unusual 
                circumstances).
                    (B) No claim for patent infringement.--An owner of 
                a patent with respect to which a holder of an 
                application under subsection (b) of section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
                fails to file information on or before the date 
                required under subparagraph (A) shall be barred from 
                bringing a civil action for infringement of the patent 
                against a person that--
                            (i) has filed an application under 
                        subsection (b)(2) or (j) of that section; or
                            (ii) manufactures, uses, offers to sell, or 
                        sells a drug approved under an application 
                        under subsection (b)(2) or (j) of that section.
    (b) Filing With an Application.--Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(C) with respect to a patent that claims both the 
                drug and a method of using the drug or claims more than 
                1 method of using the drug for which the application is 
                filed--
                            ``(i) a certification under subparagraph 
                        (A)(iv) on a claim-by-claim basis; and
                            ``(ii) a statement under subparagraph (B) 
                        regarding the method of use claim.''; and
            (2) in subsection (j)(2)(A), by inserting after clause 
        (viii) the following:
``With respect to a patent that claims both the drug and a method of 
using the drug or claims more than 1 method of using the drug for which 
the application is filed, the application shall contain a certification 
under clause (vii)(IV) on a claim-by-claim basis and a statement under 
clause (viii) regarding the method of use claim.''.

SEC. 104. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.

    (a) Abbreviated New Drug Applications.--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)--
                    (A) in clause (iii)--
                            (i) by striking ``(iii) If the applicant 
                        made a certification described in subclause 
                        (IV) of paragraph (2)(A)(vii),'' and inserting 
                        the following:
                            ``(iii) Subclause (iv) certification with 
                        respect to certain patents.--If the applicant 
                        made a certification described in paragraph 
                        (2)(A)(vii)(IV) with respect to a patent (other 
                        than a patent that claims a process for 
                        manufacturing the listed drug) for which patent 
                        information was filed with the Secretary under 
                        subsection (c)(2)(A),''; and
                            (ii) by adding at the end the following: 
                        ``The 30-month period provided under the second 
                        sentence of this clause shall not apply to a 
                        certification under paragraph (2)(A)(vii)(IV) 
                        made with respect to a patent for which patent 
                        information was filed with the Secretary under 
                        subsection (c)(2)(B).'';
                    (B) by redesignating clause (iv) as clause (v); and
                    (C) by inserting after clause (iii) the following:
                            ``(iv) Subclause (iv) certification with 
                        respect to other patents.--
                                    ``(I) In general.--If the applicant 
                                made a certification described in 
                                paragraph (2)(A)(vii)(IV) with respect 
                                to a patent not described in clause 
                                (iii) for which patent information was 
                                published by the Secretary under 
                                subsection (c)(2)(D), the approval 
                                shall be made effective on the date 
                                that is 45 days after the date on which 
                                the notice provided under paragraph 
                                (2)(B) was received, unless a civil 
                                action for infringement of the patent, 
                                accompanied by a motion for preliminary 
                                injunction to enjoin the applicant from 
                                engaging in the commercial manufacture 
                                or sale of the drug, was filed on or 
                                before the date that is 45 days after 
                                the date on which the notice was 
                                received, in which case the approval 
                                shall be made effective--
                                            ``(aa) on the date of a 
                                        court action declining to grant 
                                        a preliminary injunction; or
                                            ``(bb) if the court has 
                                        granted a preliminary 
                                        injunction prohibiting the 
                                        applicant from engaging in the 
                                        commercial manufacture or sale 
                                        of the drug--

                                                    ``(AA) on issuance 
                                                by a court of a 
                                                determination that the 
                                                patent is invalid or is 
                                                not infringed;

                                                    ``(BB) on issuance 
                                                by a court of an order 
                                                revoking the 
                                                preliminary injunction 
                                                or permitting the 
                                                applicant to engage in 
                                                the commercial 
                                                manufacture or sale of 
                                                the drug; or

                                                    ``(CC) on the date 
                                                specified in a court 
                                                order under section 
                                                271(e)(4)(A) of title 
                                                35, United States Code, 
                                                if the court determines 
                                                that the patent is 
                                                infringed.

                                    ``(II) Cooperation.--Each of the 
                                parties shall reasonably cooperate in 
                                expediting a civil action under 
                                subclause (I).
                                    ``(III) Expedited notification.--If 
                                the notice under paragraph (2)(B) 
                                contains an address for the receipt of 
                                expedited notification of a civil 
                                action under subclause (I), the 
                                plaintiff shall, on the date on which 
                                the complaint is filed, simultaneously 
                                cause a notification of the civil 
                                action to be delivered to that address 
                                by the next business day.''; and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) Failure to bring infringement action.--If, in 
                connection with an application 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 for 
                infringement of the patent in connection with the 
                development, manufacture, use, offer to sell, or sale 
                of the drug for which the application was filed or 
                approved under this subsection.''.
    (b) Other Applications.--Section 505(c)) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(c)) (as amended by section 
9(a)(3)(A)(iii)) is amended--
            (1) in paragraph (3)--
                    (A) in subparagraph (C)--
                            (i) by striking ``(C) If the applicant made 
                        a certification described in clause (iv) of 
                        subsection (b)(2)(A),'' and inserting the 
                        following:
                    ``(C) Clause (iv) certification with respect to 
                certain patents.--If the applicant made a certification 
                described in subsection (b)(2)(A)(iv) with respect to a 
                patent (other than a patent that claims a process for 
                manufacturing the listed drug) for which patent 
                information was filed with the Secretary under 
                paragraph (2)(A),''; and
                            (ii) by adding at the end the following: 
                        ``The 30-month period provided under the second 
                        sentence of this subparagraph shall not apply 
                        to a certification under subsection 
                        (b)(2)(A)(iv) made with respect to a patent for 
                        which patent information was filed with the 
                        Secretary under paragraph (2)(B).''; and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) Clause (iv) certification with respect to 
                other patents.--
                            ``(i) In general.--If the applicant made a 
                        certification described in subsection 
                        (b)(2)(A)(iv) with respect to a patent not 
                        described in subparagraph (C) for which patent 
                        information was published by the Secretary 
                        under paragraph (2)(D), the approval shall be 
                        made effective on the date that is 45 days 
                        after the date on which the notice provided 
                        under subsection (b)(3) was received, unless a 
                        civil action for infringement of the patent, 
                        accompanied by a motion for preliminary 
                        injunction to enjoin the applicant from 
                        engaging in the commercial manufacture or sale 
                        of the drug, was filed on or before the date 
                        that is 45 days after the date on which the 
                        notice was received, in which case the approval 
                        shall be made effective--
                                    ``(I) on the date of a court action 
                                declining to grant a preliminary 
                                injunction; or
                                    ``(II) if the court has granted a 
                                preliminary injunction prohibiting the 
                                applicant from engaging in the 
                                commercial manufacture or sale of the 
                                drug--
                                            ``(aa) on issuance by a 
                                        court of a determination that 
                                        the patent is invalid or is not 
                                        infringed;
                                            ``(bb) on issuance by a 
                                        court of an order revoking the 
                                        preliminary injunction or 
                                        permitting the applicant to 
                                        engage in the commercial 
                                        manufacture or sale of the 
                                        drug; or
                                            ``(cc) on the date 
                                        specified in a court order 
                                        under section 271(e)(4)(A) of 
                                        title 35, United States Code, 
                                        if the court determines that 
                                        the patent is infringed.
                            ``(ii) Cooperation.--Each of the parties 
                        shall reasonably cooperate in expediting a 
                        civil action under clause (i).
                            ``(iii) Expedited notification.--If the 
                        notice under subsection (b)(3) contains an 
                        address for the receipt of expedited 
                        notification of a civil action under clause 
                        (i), the plaintiff shall, on the date on which 
                        the complaint is filed, simultaneously cause a 
                        notification of the civil action to be 
                        delivered to that address by the next business 
                        day.''; and
            (2) by inserting after paragraph (3) the following:
            ``(4) Failure to bring infringement action.--If, in 
        connection with an application under subsection (b)(2), the 
        applicant provides an owner of a patent notice under subsection 
        (b)(3) 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 for 
        infringement of the patent in connection with the development, 
        manufacture, use, offer to sell, or sale of the drug for which 
        the application was filed or approved under subsection 
        (b)(2).''.
    (c) Effective Date.--
            (1) In general.--The amendments made by subsections (a) and 
        (b) shall be effective with respect to any certification under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
        made after the date of enactment of this Act in an application 
        filed under subsection (b)(2) or (j) of that section.
            (2) Transition provision.--In the case of applications 
        under section 505(b) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(b)) filed before the date of enactment of 
        this Act--
                    (A) a patent (other than a patent that claims a 
                process for manufacturing a listed drug) for which 
                information was submitted to the Secretary of Health 
                and Human Services under section 505(b)(1) of the 
                Federal Food, Drug, and Cosmetic Act (as in effect on 
                the day before the date of enactment of this Act) shall 
                be subject to subsections (c)(3)(C) and (j)(5)(B)(iii) 
                of section 505 of the Federal Food, Drug, and Cosmetic 
                Act (as amended by this section); and
                    (B) any other patent (including a patent for which 
                information was submitted to the Secretary under 
                section 505(c)(2) of that Act (as in effect on the day 
                before the date of enactment of this Act)) shall be 
                subject to subsections (c)(3)(D) and (j)(5)(B)(iv) of 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (as amended by this section).

SEC. 105. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.

    (a) In General.--Section 505(j)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended by section 4(a)) is 
amended--
            (1) in subparagraph (B)(v), by striking subclause (II) and 
        inserting the following:
                                    ``(II) the earlier of--
                                            ``(aa) the date of a final 
                                        decision of a court (from which 
                                        no appeal has been or can be 
                                        taken, other than a petition to 
                                        the Supreme Court for a writ of 
                                        certiorari) holding that the 
                                        patent that is the subject of 
                                        the certification is invalid or 
                                        not infringed; 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 infringed;''; 
                                        and
            (2) by inserting after subparagraph (C) the following:
                    ``(D) Forfeiture of 180-day period.--
                            ``(i) Definitions.--In this subparagraph:
                                    ``(I) Application.--The term 
                                `application' means an application for 
                                approval of a drug under this 
                                subsection containing a certification 
                                under paragraph (2)(A)(vii)(IV) with 
                                respect to a patent.
                                    ``(II) First application.--The term 
                                `first application' means the first 
                                application to be filed for approval of 
                                the drug.
                                    ``(III) Forfeiture event.--The term 
                                `forfeiture event', with respect to an 
                                application under this subsection, 
                                means the occurrence of any of the 
                                following:
                                            ``(aa) Failure to market.--
                                        The applicant fails to market 
                                        the drug by the later of--

                                                    ``(AA) the date 
                                                that is 60 days after 
                                                the date on which the 
                                                approval of the 
                                                application for the 
                                                drug is made effective 
                                                under clause (iii) or 
                                                (iv) of subparagraph 
                                                (B) (unless the 
                                                Secretary extends the 
                                                date because of 
                                                extraordinary or 
                                                unusual circumstances); 
                                                or

                                                    ``(BB) if 1 or more 
                                                civil actions have been 
                                                brought against the 
                                                applicant for 
                                                infringement of a 
                                                patent subject to a 
                                                certification under 
                                                paragraph 
                                                (2)(A)(vii)(IV) or 1 or 
                                                more civil actions have 
                                                been brought by the 
                                                applicant for a 
                                                declaratory judgment 
                                                that such a patent is 
                                                invalid or not 
                                                infringed, the date 
                                                that is 60 days after 
                                                the date of a final 
                                                decision (from which no 
                                                appeal has been or can 
                                                be taken, other than a 
                                                petition to the Supreme 
                                                Court for a writ of 
                                                certiorari) in the last 
                                                of those civil actions 
                                                to be decided (unless 
                                                the Secretary extends 
                                                the date because of 
                                                extraordinary or 
                                                unusual circumstances).

                                            ``(bb) Withdrawal of 
                                        application.--The applicant 
                                        withdraws the application.
                                            ``(cc) Amendment of 
                                        certification.--The applicant, 
                                        voluntarily or as a result of a 
                                        settlement or defeat in patent 
                                        litigation, amends the 
                                        certification from a 
                                        certification under paragraph 
                                        (2)(A)(vii)(IV) to a 
                                        certification under paragraph 
                                        (2)(A)(vii)(III).
                                            ``(dd) Failure to obtain 
                                        approval.--The applicant fails 
                                        to obtain tentative approval of 
                                        an application within 30 months 
                                        after the date on which the 
                                        application is filed, unless 
                                        the failure is caused by--

                                                    ``(AA) a change in 
                                                the requirements for 
                                                approval of the 
                                                application imposed 
                                                after the date on which 
                                                the application is 
                                                filed; or

                                                    ``(BB) other 
                                                extraordinary 
                                                circumstances 
                                                warranting an 
                                                exception, as 
                                                determined by the 
                                                Secretary.

                                            ``(ee) Failure to challenge 
                                        patent.--In a case in which, 
                                        after the date on which the 
                                        applicant submitted the 
                                        application, new patent 
                                        information is submitted under 
                                        subsection (c)(2) for the 
                                        listed drug for a patent for 
                                        which certification is required 
                                        under paragraph (2)(A), the 
                                        applicant fails to submit, not 
                                        later than the date that is 60 
                                        days after the date on which 
                                        the Secretary publishes the new 
                                        patent information under 
                                        paragraph (7)(A)(iii) (unless 
                                        the Secretary extends the date 
                                        because of extraordinary or 
                                        unusual circumstances)--

                                                    ``(AA) a 
                                                certification described 
                                                in paragraph 
                                                (2)(A)(vii)(IV) with 
                                                respect to the patent 
                                                to which the new patent 
                                                information relates; or

                                                    ``(BB) a statement 
                                                that any method of use 
                                                claim of that patent 
                                                does not claim a use 
                                                for which the applicant 
                                                is seeking approval 
                                                under this subsection 
                                                in accordance with 
                                                paragraph (2)(A)(viii).

                                            ``(ff) Unlawful conduct.--
                                        The Federal Trade Commission 
                                        determines that the applicant 
                                        engaged in unlawful conduct 
                                        with respect to the application 
                                        in violation of section 1 of 
                                        the Sherman Act (15 U.S.C. 1).
                                    ``(IV) Subsequent application.--The 
                                term `subsequent application' means an 
                                application for approval of a drug that 
                                is filed subsequent to the filing of a 
                                first application for approval of that 
                                drug.
                            ``(ii) Forfeiture of 180-day period.--
                                    ``(I) In general.--Except as 
                                provided in subclause (II), if a 
                                forfeiture event occurs with respect to 
                                a first application--
                                            ``(aa) the 180-day period 
                                        under subparagraph (B)(v) shall 
                                        be forfeited by the first 
                                        applicant; and
                                            ``(bb) any subsequent 
                                        application shall become 
                                        effective as provided under 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subparagraph (B), and 
                                        clause (v) of subparagraph (B) 
                                        shall not apply to the 
                                        subsequent application.
                                    ``(II) Forfeiture to first 
                                subsequent applicant.--If the 
                                subsequent application that is the 
                                first to be made effective under 
                                subclause (I) was the first among a 
                                number of subsequent applications to be 
                                filed--
                                            ``(aa) that first 
                                        subsequent application shall be 
                                        treated as the first 
                                        application under this 
                                        subparagraph (including 
                                        subclause (I)) and as the 
                                        previous application under 
                                        subparagraph (B)(v); and
                                            ``(bb) any other subsequent 
                                        applications shall become 
                                        effective as provided under 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subparagraph (B), but 
                                        clause (v) of subparagraph (B) 
                                        shall apply to any such 
                                        subsequent application.
                            ``(iii) Availability.--The 180-day period 
                        under subparagraph (B)(v) shall be available to 
                        a first applicant submitting an application for 
                        a drug with respect to any patent without 
                        regard to whether an application has been 
                        submitted for the drug under this subsection 
                        containing such a certification with respect to 
                        a different patent.
                            ``(iv) Applicability.--The 180-day period 
                        described in subparagraph (B)(v) shall apply to 
                        an application only if a civil action is 
                        brought against the applicant for infringement 
                        of a patent that is the subject of the 
                        certification.''.
    (b) Applicability.--The amendment made by subsection (a) shall be 
effective only with respect to an application filed under section 
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
after the date of enactment of this Act for a listed drug for which no 
certification under section 505(j)(2)(A)(vii)(IV) of that Act was made 
before the date of enactment of this Act, except that if a forfeiture 
event described in section 505(j)(5)(D)(i)(III)(ff) of that Act occurs 
in the case of an applicant, the applicant shall forfeit the 180-day 
period under section 505(j)(5)(B)(v) of that Act without regard to when 
the applicant made a certification under section 505(j)(2)(A)(vii)(IV) 
of that Act.

SEC. 106. FAIR TREATMENT FOR INNOVATORS.

    (a) Basis for Application.--Section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(3)(B), by striking the second 
        sentence and inserting ``The notice shall include a detailed 
        statement of the factual and legal basis of the applicant's 
        opinion that, as of the date of the notice, the patent is not 
        valid or is not infringed, and shall include, as appropriate 
        for the relevant patent, a description of the applicant's 
        proposed drug substance, drug formulation, drug composition, or 
        method of use. All information disclosed under this 
        subparagraph shall be treated as confidential and may be used 
        only for purposes relating to patent adjudication. Nothing in 
        this subparagraph precludes the applicant from amending the 
        factual or legal basis on which the applicant relies in patent 
        litigation.''; and
            (2) in subsection (j)(2)(B)(ii), by striking the second 
        sentence and inserting ``The notice shall include a detailed 
        statement of the factual and legal basis of the opinion of the 
        applicant that, as of the date of the notice, the patent is not 
        valid or is not infringed, and shall include, as appropriate 
        for the relevant patent, a description of the applicant's 
        proposed drug substance, drug formulation, drug composition, or 
        method of use. All information disclosed under this 
        subparagraph shall be treated as confidential and may be used 
        only for purposes relating to patent adjudication. Nothing in 
        this subparagraph precludes the applicant from amending the 
        factual or legal basis on which the applicant relies in patent 
        litigation.''.
    (b) Injunctive Relief.--Section 505(j)(5)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) (as amended by section 
4(a)(1)) is amended--
            (1) in clause (iii), by adding at the end the following: 
        ``A court shall not regard the extent of the ability of an 
        applicant to pay monetary damages as a whole or partial basis 
        on which to deny a preliminary or permanent injunction under 
        this clause.''; and
            (2) in clause (iv), by adding at the end the following:
                    ``(IV) Injunctive relief.--A court shall not regard 
                the extent of the ability of an applicant to pay 
                monetary damages as a whole or partial basis on which 
                to deny a preliminary or permanent injunction under 
                this clause.''.

SEC. 107. 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.
    (c) Effect of Section.--This section shall not be construed to 
alter the authority of the Secretary of Health and Human Services to 
regulate biological products under the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). Any such authority shall be exercised 
under that Act as in effect on the day before the date of enactment of 
this Act.

SEC. 108. REPORT.

    (a) In General.--Not later than the date that is 5 years after the 
date of enactment of this Act, the Federal Trade Commission shall 
submit to Congress a report describing the extent to which 
implementation of the amendments made by this title--
            (1) has enabled products to come to market in a fair and 
        expeditious manner, consistent with the rights of patent owners 
        under intellectual property law; and
            (2) has promoted lower prices of drugs and greater access 
        to drugs through price competition.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000.

SEC. 109. CONFORMING AND TECHNICAL AMENDMENTS.

    (a) Section 505.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (a), by striking ``(a) No person'' and 
        inserting ``(a) In General.--No person'';
            (2) in subsection (b)--
                    (A) by striking ``(b)(1) Any person'' and inserting 
                the following:
    ``(b) Applications.--
            ``(1) Requirements.--
                    ``(A) In general.--Any person'';
                    (B) in paragraph (1)--
                            (i) in the second sentence--
                                    (I) by redesignating subparagraphs 
                                (A) through (F) as clauses (i) through 
                                (vi), respectively, and adjusting the 
                                margins appropriately;
                                    (II) by striking ``Such persons'' 
                                and inserting the following:
                    ``(B) Information to be submitted with 
                application.--A person that submits an application 
                under subparagraph (A)''; and
                                    (III) by striking ``application'' 
                                and inserting ``application--'';
                            (ii) by striking the third through fifth 
                        sentences; and
                            (iii) in the sixth sentence--
                                    (I) by striking ``The Secretary'' 
                                and inserting the following:
                    ``(C) Guidance.--The Secretary''; and
                                    (II) by striking ``clause (A)'' and 
                                inserting ``subparagraph (B)(i)''; and
                    (C) in paragraph (2)--
                            (i) by striking ``clause (A) of such 
                        paragraph'' and inserting ``paragraph 
                        (1)(B)(i)'';
                            (ii) in subparagraphs (A) and (B), by 
                        striking ``paragraph (1) or''; and
                            (iii) in subparagraph (B)--
                                    (I) by striking ``paragraph 
                                (1)(A)'' and inserting ``paragraph 
                                (1)(B)(i)''; and
                                    (II) by striking ``patent'' each 
                                place it appears and inserting 
                                ``claim''; and
            (3) in subsection (c)--
                    (A) in paragraph (3)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``(A) If the 
                                applicant'' and inserting the 
                                following:
                    ``(A) Clause (i) or (ii) certification.--If the 
                applicant''; and
                                    (II) by striking ``may'' and 
                                inserting ``shall'';
                            (ii) in subparagraph (B)--
                                    (I) by striking ``(B) If the 
                                applicant'' and inserting the 
                                following:
                    ``(B) Clause (iii) certification.--If the 
                applicant''; and
                                    (II) by striking ``may'' and 
                                inserting ``shall'';
                            (iii) by redesignating subparagraph (D) as 
                        subparagraph (E); and
                            (iv) in subparagraph (E) (as redesignated 
                        by clause (iii)), by striking ``clause (A) of 
                        subsection (b)(1)'' each place it appears and 
                        inserting ``subsection (b)(1)(B)(i)''; and
                    (B) by redesignating paragraph (4) as paragraph 
                (5); and
            (4) in subsection (j)--
                    (A) in paragraph (2)(A)--
                            (i) in clause (vi), by striking ``clauses 
                        (B) through ((F)'' and inserting ``subclauses 
                        (ii) through (vi) of subsection (b)(1)'';
                            (ii) in clause (vii), by striking ``(b) 
                        or''; and
                            (iii) in clause (viii)--
                                    (I) by striking ``(b) or''; and
                                    (II) by striking ``patent'' each 
                                place it appears and inserting 
                                ``claim''; and
                    (B) in paragraph (5)--
                            (i) in subparagraph (B)--
                                    (I) in clause (i)--
                                            (aa) by striking ``(i) If 
                                        the applicant'' and inserting 
                                        the following:
                            ``(i) Subclause (i) or (ii) 
                        certification.--If the applicant''; and
                                            (bb) by striking ``may'' 
                                        and inserting ``shall'';
                                    (II) in clause (ii)--
                                            (aa) by striking ``(ii) If 
                                        the applicant'' and inserting 
                                        the following:
                            ``(i) Subclause (iii) certification.--If 
                        the applicant''; and
                                            (bb) by striking ``may'' 
                                        and inserting ``shall'';
                                    (III) in clause (iii), by striking 
                                ``(2)(B)(i)'' each place it appears and 
                                inserting ``(2)(B)''; and
                                    (IV) in clause (v) (as redesignated 
                                by section 4(a)(1)(B)), by striking 
                                ``continuing'' and inserting 
                                ``containing''; and
                            (ii) by redesignating subparagraphs (C) and 
                        (D) as subparagraphs (E) and (F), respectively.
    (b) Section 505A.--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)--
                    (A) by striking ``(c)(3)(D)(ii)'' each place it 
                appears and inserting ``(c)(3)(E)(ii)''; and
                    (B) 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)--
                    (A) by striking ``(c)(3)(D)'' each place it appears 
                and inserting ``(c)(3)(E)''; and
                    (B) by striking ``(j)(5)(D)'' each place it appears 
                and inserting ``(j)(5)(F)'';
            (3) in subsections (e) and (l)--
                    (A) by striking ``505(c)(3)(D)'' each place it 
                appears and inserting ``505(c)(3)(E)''; and
                    (B) by striking ``505(j)(5)(D)'' each place it 
                appears and inserting ``505(j)(5)(F)''; and
            (4) in subsection (k), by striking ``505(j)(5)(B)(iv)'' and 
        inserting ``505(j)(5)(B)(v)''.
    (c) Section 527.--Section 527(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the second sentence by 
striking ``505(c)(2)'' and inserting ``505(c)(1)(B)''.

              TITLE II--IMPORTATION OF PRESCRIPTION DRUGS

SEC. 201. IMPORTATION OF PRESCRIPTION DRUGS.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by striking section 804 
and inserting the following:

``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.

    ``(a) Definitions.--In this section:
            ``(1) Importer.--The term `importer' means a pharmacist or 
        wholesaler.
            ``(2) Pharmacist.--The term `pharmacist' means a person 
        licensed by a State to practice pharmacy, including the 
        dispensing and selling of prescription drugs.
            ``(3) Prescription drug.--The term `prescription drug' 
        means a drug subject to section 503(b), other than--
                    ``(A) a controlled substance (as defined in section 
                102 of the Controlled Substances Act (21 U.S.C. 802));
                    ``(B) a biological product (as defined in section 
                351 of the Public Health Service Act (42 U.S.C. 262));
                    ``(C) an infused drug (including a peritoneal 
                dialysis solution);
                    ``(D) an intravenously injected drug; or
                    ``(E) a drug that is inhaled during surgery.
            ``(4) Qualifying laboratory.--The term `qualifying 
        laboratory' means a laboratory in the United States that has 
        been approved by the Secretary for the purposes of this 
        section.
            ``(5) Wholesaler.--
                    ``(A) In general.--The term `wholesaler' means a 
                person licensed as a wholesaler or distributor of 
                prescription drugs in the United States under section 
                503(e)(2)(A).
                    ``(B) Exclusion.--The term `wholesaler' does not 
                include a person authorized to import drugs under 
                section 801(d)(1).
    ``(b) Regulations.--The Secretary, after consultation with the 
United States Trade Representative and the Commissioner of Customs, 
shall promulgate regulations permitting pharmacists and wholesalers to 
import prescription drugs from Canada into the United States.
    ``(c) Limitation.--The regulations under subsection (b) shall--
            ``(1) require that safeguards be in place to ensure that 
        each prescription drug imported under the regulations complies 
        with section 505 (including with respect to being safe and 
        effective for the intended use of the prescription drug), with 
        sections 501 and 502, and with other applicable requirements of 
        this Act;
            ``(2) require that an importer of a prescription drug under 
        the regulations comply with subsections (d)(1) and (e); and
            ``(3) contain any additional provisions determined by the 
        Secretary to be appropriate as a safeguard to protect the 
        public health or as a means to facilitate the importation of 
        prescription drugs.
    ``(d) Information and Records.--
            ``(1) In general.--The regulations under subsection (b) 
        shall require an importer of a prescription drug under 
        subsection (b) to submit to the Secretary the following 
        information and documentation:
                    ``(A) The name and quantity of the active 
                ingredient of the prescription drug.
                    ``(B) A description of the dosage form of the 
                prescription drug.
                    ``(C) The date on which the prescription drug is 
                shipped.
                    ``(D) The quantity of the prescription drug that is 
                shipped.
                    ``(E) The point of origin and destination of the 
                prescription drug.
                    ``(F) The price paid by the importer for the 
                prescription drug.
                    ``(G) Documentation from the foreign seller 
                specifying--
                            ``(i) the original source of the 
                        prescription drug; and
                            ``(ii) the quantity of each lot of the 
                        prescription drug originally received by the 
                        seller from that source.
                    ``(H) The lot or control number assigned to the 
                prescription drug by the manufacturer of the 
                prescription drug.
                    ``(I) The name, address, telephone number, and 
                professional license number (if any) of the importer.
                    ``(J)(i) In the case of a prescription drug that is 
                shipped directly from the first foreign recipient of 
                the prescription drug from the manufacturer:
                            ``(I) Documentation demonstrating that the 
                        prescription drug was received by the recipient 
                        from the manufacturer and subsequently shipped 
                        by the first foreign recipient to the importer.
                            ``(II) Documentation of the quantity of 
                        each lot of the prescription drug received by 
                        the first foreign recipient demonstrating that 
                        the quantity being imported into the United 
                        States is not more than the quantity that was 
                        received by the first foreign recipient.
                            ``(III)(aa) In the case of an initial 
                        imported shipment, documentation demonstrating 
                        that each batch of the prescription drug in the 
                        shipment was statistically sampled and tested 
                        for authenticity and degradation.
                            ``(bb) In the case of any subsequent 
                        shipment, documentation demonstrating that a 
                        statistically valid sample of the shipment was 
                        tested for authenticity and degradation.
                    ``(ii) In the case of a prescription drug that is 
                not shipped directly from the first foreign recipient 
                of the prescription drug from the manufacturer, 
                documentation demonstrating that each batch in each 
                shipment offered for importation into the United States 
                was statistically sampled and tested for authenticity 
                and degradation.
                    ``(K) Certification from the importer or 
                manufacturer of the prescription drug that the 
                prescription drug--
                            ``(i) is approved for marketing in the 
                        United States; and
                            ``(ii) meets all labeling requirements 
                        under this Act.
                    ``(L) Laboratory records, including complete data 
                derived from all tests necessary to ensure that the 
                prescription drug is in compliance with established 
                specifications and standards.
                    ``(M) Documentation demonstrating that the testing 
                required by subparagraphs (J) and (L) was conducted at 
                a qualifying laboratory.
                    ``(N) Any other information that the Secretary 
                determines is necessary to ensure the protection of the 
                public health.
            ``(2) Maintenance by the secretary.--The Secretary shall 
        maintain information and documentation submitted under 
        paragraph (1) for such period of time as the Secretary 
        determines to be necessary.
    ``(e) Testing.--The regulations under subsection (b) shall 
require--
            ``(1) that testing described in subparagraphs (J) and (L) 
        of subsection (d)(1) be conducted by the importer or by the 
        manufacturer of the prescription drug at a qualified 
        laboratory;
            ``(2) if the tests are conducted by the importer--
                    ``(A) that information needed to--
                            ``(i) authenticate the prescription drug 
                        being tested; and
                            ``(ii) confirm that the labeling of the 
                        prescription drug complies with labeling 
                        requirements under this Act;
                be supplied by the manufacturer of the prescription 
                drug to the pharmacist or wholesaler; and
                    ``(B) that the information supplied under 
                subparagraph (A) be kept in strict confidence and used 
                only for purposes of testing or otherwise complying 
                with this Act; and
            ``(3) may include such additional provisions as the 
        Secretary determines to be appropriate to provide for the 
        protection of trade secrets and commercial or financial 
        information that is privileged or confidential.
    ``(f) Registration of Foreign Sellers.--Any establishment within 
Canada engaged in the distribution of a prescription drug that is 
imported or offered for importation into the United States shall 
register with the Secretary the name and place of business of the 
establishment.
    ``(g) Suspension of Importation.--The Secretary shall require that 
importations of a specific prescription drug or importations by a 
specific importer under subsection (b) be immediately suspended on 
discovery of a pattern of importation of the prescription drugs or by 
the importer that is counterfeit or in violation of any requirement 
under this section or poses an additional risk to the public health, 
until an investigation is completed and the Secretary determines that 
the public is adequately protected from counterfeit and violative 
prescription drugs being imported under subsection (b).
    ``(h) Approved Labeling.--The manufacturer of a prescription drug 
shall provide an importer written authorization for the importer to 
use, at no cost, the approved labeling for the prescription drug.
    ``(i) Prohibition of Discrimination.--
            ``(1) In general.--It shall be unlawful for a manufacturer 
        of a prescription drug to discriminate against, or cause any 
        other person to discriminate against, a pharmacist or 
        wholesaler that purchases or offers to purchase a prescription 
        drug from the manufacturer or from any person that distributes 
        a prescription drug manufactured by the drug manufacturer.
            ``(2) Discrimination.--For the purposes of paragraph (1), a 
        manufacturer of a prescription drug shall be considered to 
        discriminate against a pharmacist or wholesaler if the 
        manufacturer enters into a contract for sale of a prescription 
        drug, places a limit on supply, or employs any other measure, 
        that has the effect of--
                    ``(A) providing pharmacists or wholesalers access 
                to prescription drugs on terms or conditions that are 
                less favorable than the terms or conditions provided to 
                a foreign purchaser (other than a charitable or 
                humanitarian organization) of the prescription drug; or
                    ``(B) restricting the access of pharmacists or 
                wholesalers to a prescription drug that is permitted to 
                be imported into the United States under this section.
    ``(j) Charitable Contributions.--Notwithstanding any other 
provision of this section, section 801(d)(1) continues to apply to a 
prescription drug that is donated or otherwise supplied at no charge by 
the manufacturer of the drug to a charitable or humanitarian 
organization (including the United Nations and affiliates) or to a 
government of a foreign country.
    ``(k) Waiver Authority for Importation by Individuals.--
            ``(1) Declarations.--Congress declares that in the 
        enforcement against individuals of the prohibition of 
        importation of prescription drugs and devices, the Secretary 
        should--
                    ``(A) focus enforcement on cases in which the 
                importation by an individual poses a significant threat 
                to public health; and
                    ``(B) exercise discretion to permit individuals to 
                make such importations in circumstances in which--
                            ``(i) the importation is clearly for 
                        personal use; and
                            ``(ii) the prescription drug or device 
                        imported does not appear to present an 
                        unreasonable risk to the individual.
            ``(2) Waiver authority.--
                    ``(A) In general.--The Secretary may grant to 
                individuals, by regulation or on a case-by-case basis, 
                a waiver of the prohibition of importation of a 
                prescription drug or device or class of prescription 
                drugs or devices, under such conditions as the 
                Secretary determines to be appropriate.
                    ``(B) Guidance on case-by-case waivers.--The 
                Secretary shall publish, and update as necessary, 
                guidance that accurately describes circumstances in 
                which the Secretary will consistently grant waivers on 
                a case-by-case basis under subparagraph (A), so that 
                individuals may know with the greatest practicable 
                degree of certainty whether a particular importation 
                for personal use will be permitted.
            ``(3) Drugs imported from canada.--In particular, the 
        Secretary shall by regulation grant individuals a waiver to 
        permit individuals to import into the United States a 
        prescription drug that--
                    ``(A) is imported from a licensed pharmacy for 
                personal use by an individual, not for resale, in 
                quantities that do not exceed a 90-day supply;
                    ``(B) is accompanied by a copy of a valid 
                prescription;
                    ``(C) is imported from Canada, from a seller 
                registered with the Secretary;
                    ``(D) is a prescription drug approved by the 
                Secretary under chapter V;
                    ``(E) is in the form of a final finished dosage 
                that was manufactured in an establishment registered 
                under section 510; and
                    ``(F) is imported under such other conditions as 
                the Secretary determines to be necessary to ensure 
                public safety.
    ``(l) Studies; Reports.--
            ``(1) By the institute of medicine of the national academy 
        of sciences.--
                    ``(A) Study.--
                            ``(i) In general.--The Secretary shall 
                        request that the Institute of Medicine of the 
                        National Academy of Sciences conduct a study 
                        of--
                                    ``(I) importations of prescription 
                                drugs made under the regulations under 
                                subsection (b); and
                                    ``(II) information and 
                                documentation submitted under 
                                subsection (d).
                            ``(ii) Requirements.--In conducting the 
                        study, the Institute of Medicine shall--
                                    ``(I) evaluate the compliance of 
                                importers with the regulations under 
                                subsection (b);
                                    ``(II) compare the number of 
                                shipments under the regulations under 
                                subsection (b) during the study period 
                                that are determined to be counterfeit, 
                                misbranded, or adulterated, and compare 
                                that number with the number of 
                                shipments made during the study period 
                                within the United States that are 
                                determined to be counterfeit, 
                                misbranded, or adulterated; and
                                    ``(III) consult with the Secretary, 
                                the United States Trade Representative, 
                                and the Commissioner of Patents and 
                                Trademarks to evaluate the effect of 
                                importations under the regulations 
                                under subsection (b) on trade and 
                                patent rights under Federal law.
                    ``(B) Report.--Not later than 2 years after the 
                effective date of the regulations under subsection (b), 
                the Institute of Medicine shall submit to Congress a 
                report describing the findings of the study under 
                subparagraph (A).
            ``(2) By the comptroller general.--
                    ``(A) Study.--The Comptroller General of the United 
                States shall conduct a study to determine the effect of 
                this section on the price of prescription drugs sold to 
                consumers at retail.
                    ``(B) Report.--Not later than 18 months after the 
                effective date of the regulations under subsection (b), 
                the Comptroller General of the United States shall 
                submit to Congress a report describing the findings of 
                the study under subparagraph (A).
    ``(m) Construction.--Nothing in this section limits the authority 
of the Secretary relating to the importation of prescription drugs, 
other than with respect to section 801(d)(1) as provided in this 
section.
    ``(n) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out this section.
    ``(o) Conditions.--This section shall become effective only if the 
Secretary of Health and Human Services certifies to the Congress that 
the implementation of this section will--
            ``(A) pose no additional risk to the public's health and 
        safety, and
            ``(B) result in a significant reduction in the cost of 
        covered products to the American consumer.''.
    (b) Conforming Amendments.--The Federal Food, Drug, and Cosmetic 
Act is amended--
            (1) in section 301(aa) (21 U.S.C. 331(aa)), by striking 
        ``covered product in violation of section 804'' and inserting 
        ``prescription drug in violation of section 804''; and
            (2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking 
        ``covered product pursuant to section 804(a)'' and inserting 
        ``prescription drug under section 804(b)''.

SEC. 202. CLARIFICATION OF STATE AUTHORITY RELATING TO MEDICAID DRUG 
              REBATE AGREEMENTS.

    Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) is 
amended by adding at the end the following:
    ``(l) Rule of Construction.--Nothing in this section shall be 
construed as prohibiting a State from--
            ``(1) directly entering into rebate agreements (on the 
        State's own initiative or under a section 1115 waiver approved 
        by the Secretary before, on, or after the date of enactment of 
        this subsection) that are similar to a rebate agreement 
        described in subsection (b) with a manufacturer for purposes of 
        ensuring the affordability of outpatient prescription drugs in 
        order to provide access to such drugs by residents of a State 
        who are not otherwise eligible for medical assistance under 
        this title; or
            ``(2) making prior authorization (that satisfies the 
        requirements of subsection (d) and that does not violate any 
        requirements of this title that are designed to ensure access 
        to medically necessary prescribed drugs for individuals 
        enrolled in the State program under this title) a condition of 
        not participating in such a similar rebate agreement.''.

SEC. 203. TEMPORARY STATE FISCAL RELIEF.

    (a) Temporary Increase of Medicaid FMAP.--
            (1) Permitting maintenance of fiscal year 2001 fmap for 
        last 2 calendar quarters of fiscal year 2002.--Notwithstanding 
        any other provision of law, but subject to paragraph (5), if 
        the FMAP determined without regard to this subsection for a 
        State for fiscal year 2002 is less than the FMAP as so 
        determined for fiscal year 2001, the FMAP for the State for 
        fiscal year 2001 shall be substituted for the State's FMAP for 
        the third and fourth calendar quarters of fiscal year 2002, 
        before the application of this subsection.
            (2) Permitting maintenance of fiscal year 2002 fmap for 
        fiscal year 2003.--Notwithstanding any other provision of law, 
        but subject to paragraph (5), if the FMAP determined without 
        regard to this subsection for a State for fiscal year 2003 is 
        less than the FMAP as so determined for fiscal year 2002, the 
        FMAP for the State for fiscal year 2002 shall be substituted 
        for the State's FMAP for each calendar quarter of fiscal year 
        2003, before the application of this subsection.
            (3) General 1.35 percentage points increase for last 2 
        calendar quarters of fiscal year 2002 and fiscal year 2003.--
        Notwithstanding any other provision of law, but subject to 
        paragraphs (5) and (6), for each State for the third and fourth 
        calendar quarters of fiscal year 2002 and each calendar quarter 
        of fiscal year 2003, the FMAP (taking into account the 
        application of paragraphs (1) and (2)) shall be increased by 
        1.35 percentage points.
            (4) Increase in cap on medicaid payments to territories.--
        Notwithstanding any other provision of law, but subject to 
        paragraph (6), with respect to the third and fourth calendar 
        quarters of fiscal year 2002 and each calendar quarter of 
        fiscal year 2003, the amounts otherwise determined for Puerto 
        Rico, the Virgin Islands, Guam, the Northern Mariana Islands, 
        and American Samoa under subsections (f) and (g) of section 
        1108 of the Social Security Act (42 U.S.C. 1308) shall each be 
        increased by an amount equal to 2.7 percent of such amounts.
            (5) Scope of application.--The increases in the FMAP for a 
        State under this subsection shall apply only for purposes of 
        title XIX of the Social Security Act and shall not apply with 
        respect to--
                    (A) disproportionate share hospital payments 
                described in section 1923 of such Act (42 U.S.C. 1396r-
                4); or
                    (B) payments under title IV or XXI of such Act (42 
                U.S.C. 601 et seq. and 1397aa et seq.).
            (6) State eligibility.--
                    (A) In general.--Subject to subparagraph (B), a 
                State is eligible for an increase in its FMAP under 
                paragraph (3) or an increase in a cap amount under 
                paragraph (4) only if the eligibility under its State 
                plan under title XIX of the Social Security Act 
                (including any waiver under such title or under section 
                1115 of such Act (42 U.S.C. 1315)) is no more 
                restrictive than the eligibility under such plan (or 
                waiver) as in effect on January 1, 2002.
                    (B) State reinstatement of eligibility permitted.--
                A State that has restricted eligibility under its State 
                plan under title XIX of the Social Security Act 
                (including any waiver under such title or under section 
                1115 of such Act (42 U.S.C. 1315)) after January 1, 
                2002, but prior to the date of enactment of this Act is 
                eligible for an increase in its FMAP under paragraph 
                (3) or an increase in a cap amount under paragraph (4) 
                in the first calendar quarter (and subsequent calendar 
                quarters) in which the State has reinstated eligibility 
                that is no more restrictive than the eligibility under 
                such plan (or waiver) as in effect on January 1, 2002.
                    (C) Rule of construction.--Nothing in subparagraph 
                (A) or (B) shall be construed as affecting a State's 
                flexibility with respect to benefits offered under the 
                State medicaid program under title XIX of the Social 
                Security Act (42 U.S.C. 1396 et seq.) (including any 
                waiver under such title or under section 1115 of such 
                Act (42 U.S.C. 1315)).
            (7) Definitions.--In this subsection:
                    (A) FMAP.--The term ``FMAP'' means the Federal 
                medical assistance percentage, as defined in section 
                1905(b) of the Social Security Act (42 U.S.C. 
                1396d(b)).
                    (B) State.--The term ``State'' has the meaning 
                given such term for purposes of title XIX of the Social 
                Security Act (42 U.S.C. 1396 et seq.).
            (8) Repeal.--Effective as of October 1, 2003, this 
        subsection is repealed.
    (b) Additional Temporary State Fiscal Relief.--
            (1) In general.--Title XX of the Social Security Act (42 
        U.S.C. 1397-1397f) is amended by adding at the end the 
        following:

``SEC. 2008. ADDITIONAL TEMPORARY GRANTS FOR STATE FISCAL RELIEF.

    ``(a) In General.--For the purpose of providing State fiscal relief 
allotments to States under this section, there are hereby appropriated, 
out of any funds in the Treasury not otherwise appropriated, 
$3,000,000,000. Such funds shall be available for obligation by the 
State through June 30, 2004, and for expenditure by the State through 
September 30, 2004. This section constitutes budget authority in 
advance of appropriations Acts and represents the obligation of the 
Federal Government to provide for the payment to States of amounts 
provided under this section.
    ``(b) Allotment.--Funds appropriated under subsection (a) shall be 
allotted by the Secretary among the States in accordance with the 
following table:

      

------------------------------------------------------------------------
               ``State                       Allotment (in dollars)
------------------------------------------------------------------------
 Alabama                                $33,918,100
 
 Alaska                                 $8,488,200
 
 Amer. Samoa                            $88,600
 
 Arizona                                $47,601,600
 
 Arkansas                               $27,941,800
 
 California                             $314,653,900
 
 Colorado                               $27,906,200
 
 Connecticut                            $41,551,200
 
 Delaware                               $8,306,000
 
 District of Columbia                   $12,374,400
 
 Florida                                $128,271,100
 
 Georgia                                $69,106,600
 
 Guam                                   $135,900
 
 Hawaii                                 $9,914,700
 
 Idaho                                  $10,293,600
 
 Illinois                               $102,577,900
 
 Indiana                                $50,659,800
 
 Iowa                                   $27,799,700
 
 Kansas                                 $21,414,300
 
 Kentucky                               $44,508,400
 
 Louisiana                              $50,974,000
 
 Maine                                  $17,841,100
 
 Maryland                               $44,228,800
 
 Massachusetts                          $100,770,700
 
 Michigan                               $91,196,800
 
 Minnesota                              $57,515,400
 
 Mississippi                            $35,978,500
 
 Missouri                               $62,189,600
 
 Montana                                $8,242,000
 
 Nebraska                               $16,671,600
 
 Nevada                                 $10,979,700
 
 New Hampshire                          $10,549,400
 
 New Jersey                             $87,577,300
 
 New Mexico                             $21,807,600
 
 New York                               $461,401,900
 
 North Carolina                         $79,538,300
 
 North Dakota                           $5,716,900
 
 N. Mariana Islands                     $50,000
 
 Ohio                                   $116,367,800
 
 Oklahoma                               $30,941,800
 
 Oregon                                 $34,327,200
 
 Pennsylvania                           $159,089,700
 
 Puerto Rico                            $3,991,900
 
 Rhode Island                           $16,594,100
 
 South Carolina                         $38,238,000
 
 South Dakota                           $6,293,700
 
 Tennessee                              $81,120,000
 
 Texas                                  $159,779,800
 
 Utah                                   $12,551,700
 
 Vermont                                $8,003,800
 
 Virgin Islands                         $128,800
 
 Virginia                               $44,288,300
 
 Washington                             $66,662,200
 
 West Virginia                          $19,884,400
 
 Wisconsin                              $47,218,900
 
 Wyoming                                $3,776,400
 
------------------------------------------------------------------------
 
 Total                                  $3,000,000,000
------------------------------------------------------------------------

    ``(c) Use of Funds.--Funds appropriated under this section may be 
used by a State for services directed at the goals set forth in section 
2001, subject to the requirements of this title.
    ``(d) Payment to States.--Not later than 30 days after amounts are 
appropriated under subsection (a), in addition to any payment made 
under section 2002 or 2007, the Secretary shall make a lump sum payment 
to a State of the total amount of the allotment for the State as 
specified in subsection (b).
    ``(e) Definition.--For purposes of this section, the term `State' 
means the 50 States, the District of Columbia, and the territories 
contained in the list under subsection (b).''.
            (2) Repeal.--Effective as of January 1, 2005, section 2008 
        of the Social Security Act, as added by paragraph (1), is 
        repealed.
    (c) Emergency Designation.--The entire amount necessary to carry 
out this section is designated by Congress as an emergency requirement 
pursuant to section 252(e) of the Balanced Budget and Emergency Deficit 
Control Act of 1985 (2 U.S.C. 902(e)).

            Passed the Senate July 31, 2002.

            Attest:

                                                             Secretary.
107th CONGRESS

  2d Session

                                 S. 812

_______________________________________________________________________

                                 AN ACT

 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.