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







107th CONGRESS
  1st Session
                                 S. 812

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 1, 2001

Mr. Schumer (for himself and Mr. McCain) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Greater Access to Affordable 
Pharmaceuticals Act of 2001''.

SEC. 2. 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 Act 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. 3. ACCELERATED GENERIC DRUG COMPETITION.

    (a) In General.--Section 505(j)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (B)(iv), by striking subclause (II) and 
        inserting the following:
                    ``(II) the earlier of--
                            ``(aa) the date of a final decision of a 
                        court in an action described in clause (iii) 
                        (from which no appeal can or has been 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 patents that are the subject of the 
                        certification are invalid or not infringed;'';
            (2) by redesignating subparagraphs (C) and (D) as 
        subparagraphs (E) and (F), respectively; and
            (3) by inserting after subparagraph (B) the following:
                    ``(C) Forfeiture of 180-day period.--
                            ``(i) In general.--The 180-day period 
                        described in subparagraph (B)(iv) shall be 
                        forfeited by the previous applicant and become 
                        available to the next applicant submitting an 
                        application containing a certification 
                        described in paragraph (2)(A)(vii)(IV) if--
                                    ``(I) the previous applicant fails 
                                to market the drug within 90 days after 
                                the date on which the approval of the 
application for the drug is made effective under subparagraph (B)(iii);
                                    ``(II) the previous applicant 
                                withdraws the application;
                                    ``(III) the previous applicant 
                                amends the certification from a 
                                certification under subclause (IV) to a 
                                certification under paragraph 
                                (2)(A)(vii)(III), either voluntarily or 
                                as a result of a settlement or defeat 
                                in patent litigation;
                                    ``(IV) the previous applicant fails 
                                to get tentative approval of the 
                                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 tentative 
                                        approval of the application 
                                        imposed after the date on which 
                                        the application was filed; or
                                            ``(bb) other extraordinary 
                                        or unusual circumstances, as 
                                        determined by the Secretary;
                                    ``(V) in a case in which, after the 
                                date on which the previous application 
                                was submitted under this subsection, 
                                new patent information is submitted for 
                                the drug under subsection (c)(2) for a 
                                patent for which certification is 
                                required under paragraph 
                                (2)(A)(vii)(IV), the previous applicant 
                                fails to challenge the patent that is 
                                the subject of the information within 
                                60 days after the date on which the 
                                patent information is submitted; or
                                    ``(VI) the previous applicant is 
                                determined by the Secretary, after a 
                                fair and sufficient hearing and in 
                                consultation with the Federal Trade 
                                Commission, to have engaged in 
                                anticompetitive or collusive conduct, 
                                or any other conduct intended to 
                                unfairly monopolize the commercial 
                                manufacturing of the drug of the 
                                application.
                            ``(ii) Availability.--The 180-day period 
                        described in subparagraph (B)(iv) shall be 
                        available only to--
                                    ``(I) the previous applicant 
                                submitting an application for a drug 
                                under this subsection containing a 
                                certification described in paragraph 
                                (2)(A)(vii)(IV) with respect to any 
                                patent; or
                                    ``(II) under clause (i), the next 
                                applicant submitting an application for 
                                a drug under this subsection containing 
                                such a certification with respect to 
                                any patent;
                        even if an application has been submitted for 
                        the drug under this subsection containing such 
                        a certification with respect to a different 
                        patent.
                            ``(iii) Applicability.--The 180-day period 
                        described in subparagraph (B)(iv) shall apply 
                        only if--
                                    ``(I) the application contains a 
                                certification described in paragraph 
                                (2)(A)(vii)(IV); and
                                    ``(II) an action is brought for 
                                infringement of a patent that is the 
                                subject of the certification or the 
                                applicant brings an action (not later 
                                than 50 days after the date on which 
                                the notice provided under paragraph 
                                (2)(B)(ii) was received), against the 
                                holder of the approved application for 
                                the listed drug.''.
    (b) Effective Date.--The amendment made by this section 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)) 
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.

SEC. 4. BIOEQUIVALENCE TESTING METHODS.

    Section 505(j)(8)(B) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(8)(B)) is amended--
            (1) in clause (i), by striking ``or'' at the end;
            (2) in clause (ii), by striking the period at the end and 
        inserting ``; or''; and
            (3) by adding at the end the following:
                    ``(iii)(I) clauses (i) and (ii) are not applicable, 
                as determined by the Secretary;
                    ``(II) the effects of the drug and the listed drug 
                do not show a significant difference based on tests 
                (other than tests that assess rate and extent of 
                absorption), including--
                            ``(aa) a bioequivalence study with a 
                        pharmacodynamic endpoint;
                            ``(bb) a bioequivalence study with a 
                        clinical endpoint;
                            ``(cc) in vitro methods; or
                            ``(dd) any other methodology that 
                        demonstrates that no significant differences in 
                        therapeutic effects of active ingredients are 
                        expected; and
                    ``(III) limited confirmatory studies to supplement 
                the bioequivalence testing are considered necessary by 
                the Secretary.''.

SEC. 5. CITIZEN PETITIONS.

    Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)) (as amended by section 3(a)) is amended by inserting 
after subparagraph (C) the following:
                    ``(D) Citizen petitions.--
                            ``(i) In general.--Notwithstanding any 
                        other provision of law, any petition submitted 
                        under section 10.30 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulation), shall include a statement that to 
                        the best knowledge and belief of the 
                        petitioner, the petition--
                                    ``(I) includes all information and 
                                views on which the petitioner relies;
                                    ``(II) is well grounded in fact and 
                                is warranted by law (including 
                                regulations);
                                    ``(III) is not submitted for any 
                                improper purpose, such as to harass or 
                                cause unnecessary delay;
                                    ``(IV) does not contain a 
                                materially false, misleading, or 
                                fraudulent statement that the 
                                petitioner has knowingly and willingly 
                                included; and
                                    ``(V) includes all representative 
                                data and information known to the 
                                petitioner that is favorable or 
                                unfavorable to the petition.
                            ``(ii) Applicability of criminal 
                        provision.--Section 1001 of title 18, United 
                        States Code, shall apply to a person that 
                        submits a petition under section 10.30 of title 
                        21, Code of Federal Regulations (or any 
                        successor regulation).
                            ``(iii) Investigations.--
                                    ``(I) In general.--The Federal 
                                Trade Commission shall investigate, on 
                                receipt of a complaint or upon its own 
                                initiative, any petition submitted 
                                under section 10.30 of title 21, Code 
                                of Federal Regulations (or any 
                                successor regulation), that may have 
                                been submitted for an improper purpose, 
                                such as to delay competition or agency 
                                action.
                                    ``(II) Referral.--If the Commission 
                                finds that a petitioner has engaged in 
                                conduct that may be illegal, the 
                                Commission shall refer the petition to 
                                the Antitrust Division of the 
                                Department of Justice for further 
                                action.
                            ``(iv) Notice of receipt of 
                        consideration.--
                                    ``(I) In general.--A person that 
                                submits a petition under section 10.30 
                                of title 21, Code of Federal 
                                Regulations (or any successor 
                                regulation), shall provide a written 
                                notice to the Federal Trade Commission 
                                if the person receives any 
                                consideration for submitting the 
                                petition.
                                    ``(II) A notice under subclause (I) 
                                shall include--
                                            ``(aa) the name of the 
                                        person or entity that provided 
                                        the consideration;
                                            ``(bb) the dollar value of 
                                        the consideration, if provided 
                                        in cash, or a description of 
                                        such consideration;
                                            ``(cc) the date on which 
                                        the consideration was provided; 
                                        and
                                            ``(dd) any other 
                                        information that the Commission 
                                        requires to be disclosed.''.

SEC. 6. PATENT CERTIFICATION.

    (a) Abbreviated New Drug Applications.--Section 505(j)(5) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as amended 
by section 3(a)(2)) is amended--
            (1) in subparagraph (B), by striking clause (iii) and 
        inserting the following:
                            ``(iii) Certification that patent is 
                        invalid or will not be infringed.--
                                    ``(I) In general.--Except as 
                                provided in subclauses (II) and (III), 
                                if the applicant made a certification 
                                described in paragraph (2)(A)(vii)(IV), 
                                the approval shall be made effective on 
                                the expiration of 45 days after the 
                                date on which the notice provided under 
                                paragraph (2)(B)(ii) was received.
                                    ``(II) Action for patent 
                                infringement.--If an action is brought 
                                for infringement of a patent that is 
                                the subject of the certification before 
                                the expiration of the 45-day period 
                                beginning on the date on which the 
                                notice provided under paragraph 
                                (2)(B)(ii) was received, the approval 
                                shall be made effective on the 
                                expiration of the 45-day period unless 
                                the court grants a preliminary 
                                injunction prohibiting the applicant 
                                from engaging in the commercial 
                                manufacture or sale of the drug until 
                                the court decides the issues of patent 
                                validity and infringement.
                                    ``(III) Patent invalid or not 
                                infringed.--If the court decides that 
                                the patent is invalid or was not 
                                infringed, the approval shall be made 
                                effective on the date of the court 
                                decision.
                                    ``(IV) Patent infringed.--If the 
                                court decides that the patent was 
                                infringed, the approval shall be made 
                                effective on such date as the court 
                                orders under section 271(e)(4)(A) of 
                                title 35, United States Code.
                                    ``(V) Procedure.--In an action 
                                described in subclause (II)--
                                            ``(aa) each of the parties 
                                        shall reasonably cooperate in 
                                        expediting the action;
                                            ``(bb) until the expiration 
                                        of 45 days after the date the 
                                        notice provided under paragraph 
                                        (2)(B)(i) was received, no 
                                        civil action may be brought 
                                        under section 2201 of title 28, 
                                        United States Code, for a 
                                        declaratory judgment with 
                                        respect to the patent, except 
                                        as provided in subparagraph 
                                        (H); and
                                            ``(cc) any such civil 
                                        action shall be brought in the 
                                        judicial district in which the 
                                        defendant has its principal 
                                        place of business or a regular 
                                        and established place of 
                                        business.''; and
            (2) by adding at the end the following:
                    ``(G) Civil action for declaratory judgment.--A 
                person that files an abbreviated application for a new 
                drug under this paragraph may bring a civil action 
                against the holder of an approved application for a 
                listed drug for a declaratory judgment to determine 
                whether the patent that claims the listed drug or a 
                method of using the drug is invalid or will not be 
                infringed.
                    ``(H) Civil action to determine legal status.--
                Notwithstanding any other provision of law, if 
                information on a patent for a listed drug has been 
                published under subsection (c)(2) for at least 1 year 
                after the date on which an abbreviated application for 
                approval of a new drug was filed under this subsection 
                in relation to the listed drug, the person that filed 
                the abbreviated application or the holder of the 
                approved application for the listed drug may 
                immediately bring a civil action to determine the legal 
                status of the patent for the listed drug.''.
    (b) New Drug Applications.--Section 505(c)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) is amended by striking 
subparagraph (C) and inserting the following:
                    ``(C) Certification that patent is invalid or will 
                not be infringed.--
                            ``(i) In general.--Except as provided in 
                        clauses (ii) and (iii), if the applicant made a 
                        certification described in subsection 
                        (b)(2)(A)(iv), the approval shall be made 
                        effective on the expiration of 45 days after 
                        the date on which the notice provided under 
                        subsection (b)(3)(B) was received.
                            ``(ii) Action brought before expiration of 
                        45 days.--If an action is brought for 
                        infringement of a patent that is the subject of 
                        the certification before the expiration of the 
                        45-day period beginning on the date the notice 
                        provided under subsection (b)(3)(B) was 
                        received, the approval shall be made effective 
                        on the expiration of the 45-day period unless 
                        the court grants a preliminary injunction 
                        prohibiting the applicant from engaging in the 
                        commercial manufacture or sale of the drug 
                        until the court decides the issues of patent 
                        validity and infringement.
                            ``(iii) Patent invalid or not infringed.--
                        If the court decides that the patent is invalid 
                        or not infringed, the approval shall be made 
                        effective on the date of the court decision.
                            ``(iv) Patent infringed.--If the court 
                        decides that the patent has been infringed, the 
                        approval may be made effective on such date as 
                        the court orders under section 271(e)(4)(A) of 
                        title 35, United States Code.
                            ``(v) Procedure.--In an action described in 
                        clause (ii)--
                                    ``(I) each of the parties shall 
                                reasonably cooperate in expediting the 
                                action;
                                    ``(II) until the expiration of 45 
                                days after the date the notice provided 
                                under subsection (b)(3)(B) was 
                                received, no civil action may be 
                                brought under section 2201 of title 28, 
                                United States Code, for a declaratory 
                                judgment with respect to the patent, 
                                except as provided in subsection 
                                (j)(5)(H); and
                                    ``(III) any such civil action shall 
                                be brought in the judicial district 
                                where the defendant has its principal 
                                place of business or a regular and 
                                established place of business.''.
    (c) Effective Date.--The amendments made by this section shall not 
apply to an application submitted under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) before the date of 
enactment of this Act.

SEC. 7. PATENT INFORMATION.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended--
            (1) in subsection (b), by striking ``(b)(1) Any person'' 
        and all that follows through paragraph (1) and inserting the 
        following:
    ``(b) Applications.--
            ``(1) In general.--
                    ``(A) Filing.--Any person may file with the 
                Secretary an application with respect to any drug 
                subject to subsection (a).
                    ``(B) Contents.--A person that files an application 
                shall submit to the Secretary as a part of the 
                application with respect to a drug--
                            ``(i) full reports of investigations that 
                        have been made to show whether or not such drug 
                        is safe for use and whether the drug is 
                        effective in use;
                            ``(ii) a full list of the articles used as 
                        components of the drug;
                            ``(iii) a full statement of the composition 
                        of the drug;
                            ``(iv) a full description of the methods 
                        used in, and the facilities and controls used 
                        for, the manufacture, processing, and packing 
                        of the drug;
                            ``(v) such samples of the drug and of the 
                        articles used as components of the drug as the 
                        Secretary may require; and
                            ``(vi) specimens of the labeling proposed 
                        to be used for the drug.
                    ``(C) Patent information.--
                            ``(i) In general.--The applicant shall file 
                        with the application the patent number and 
                        expiration date of any patent that claims a 
                        drug or method of using a drug and 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 for which the applicant 
                        submitted the application.
                            ``(ii) Amendment of application.--If an 
                        application is filed with respect to a drug and 
                        a patent as described in clause (i) is issued 
                        after the filing date but before approval of 
                        the application, the applicant shall amend the 
                        application to include the information required 
                        by clause (i).
                            ``(iii) Publication of information.--On 
                        approval of the application, the Secretary 
                        shall publish information submitted under 
                        clauses (i) and (ii).
                    ``(D) Guidance.--The Secretary shall, in 
                consultation with the Director of the National 
                Institutes of Health and with representatives of the 
                drug manufacturing industry, review and develop 
                guidance, as appropriate, on the inclusion of women and 
                minorities in clinical trials required by subparagraph 
                (B)(i).''; and
            (2) in paragraph (2)(A)--
                    (A) by striking ``which claims'' the first place it 
                appears and all that follows through ``subsection 
                and''; and
                    (B) by striking ``subsection (c)--'' and inserting 
                ``and 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 for which the investigations 
                were conducted--'';
            (3) in the first sentence of subsection (c)(2)--
                    (A) by inserting ``such patent information'' after 
                ``shall file''; and
                    (B) by striking ``Secretary,'' and all that follows 
                and inserting ``Secretary.'';
            (4) in subsection (j)(2)(vii), by striking ``which claims 
        the listed drug'' and all that follows through ``under this 
        subsection and'' and inserting ``for the listed drug referred 
        to in clause (i)''; and
            (5) by adding at the end the following:
    ``(o) Patent Information.--
            ``(1) Applicability.--This subsection applies to a holder 
        of an approved application under subsection (c) that files a 
        patent--
                    ``(A) that claims, with regard to a drug of the 
                application, a drug or method of using a drug; and
                    ``(B) for 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, after the date of approval of the 
                application.
            ``(2) Certification.--A holder of a patent described in 
        paragraph (1) shall--
                    ``(A) inform the Secretary of the filing of the 
                patent; and
                    ``(B) certify that the information is a complete 
                and accurate listing of all such patents.
            ``(3) Secretary.--The Secretary shall list the information 
        provided under paragraph (2) in accordance with subsection 
        (j)(7).''.

SEC. 8. 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 Act--
            (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.
                                 <all>