New Medications to Treat Addiction Act of 1998

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``New Medications to Treat Addiction 
Act of 1998''.

                   TITLE I--PHARMACOTHERAPY RESEARCH

SEC. 101. REAUTHORIZATION FOR MEDICATION DEVELOPMENT PROGRAM.

    Section 464P(e) of the Public Health Service Act (42 U.S.C. 285o-
4(e)) is amended to read as follows:
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of the fiscal years 1999 through 2001 of which the following 
amount may be appropriated from the Violent Crime Reduction Trust Fund:
            ``(1) $100,000,000 for fiscal year 2000; and
            ``(2) $100,000,000 for fiscal year 2001.''.

           TITLE II--PATENT PROTECTIONS FOR PHARMACOTHERAPIES

SEC. 201. RECOMMENDATION FOR INVESTIGATION OF DRUGS.

    Section 525(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360aa(a)) is amended--
            (1) in the first sentence, by striking ``States'' and 
        inserting ``States, or for treatment of an addiction to illegal 
        drugs,'';
            (2) in the second sentence, by striking ``States'' and 
        inserting ``States, or for treatment of an addiction to illegal 
        drugs''; and
            (3) by striking ``such disease or condition'' each place it 
        appears and inserting ``such disease or condition, or treatment 
        of such addiction,''.

SEC. 202. DESIGNATION OF DRUGS.

    Section 526(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bb(a)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting before the period in the first 
                sentence the following: ``, or for treatment of an 
                addiction to illegal drugs'';
                    (B) in the third sentence, by striking ``rare 
                disease or condition'' and inserting ``rare disease or 
                condition, or for treatment of an addiction to illegal 
                drugs,'';
                    (C) by striking ``such disease or condition,'' and 
                inserting ``such disease or condition, or treatment of 
                such addiction,''; and
                    (D) by striking ``such disease or condition.'' and 
                inserting ``such disease or condition, or treatment of 
                such addiction.''; and
            (2) in paragraph (2)--
                    (A) by striking ``(2) For'' and inserting ``(2)(A) 
                For'';
                    (B) by striking ``(A) affects'' and inserting ``(i) 
                affects'';
                    (C) by striking ``(B) affects'' and inserting 
                ``(ii) affects''; and
                    (D) by adding at the end the following:
    ``(B) For purposes of this subchapter, the term `treatment of an 
addiction to illegal drugs' means treatment by any pharmacological 
agent or medication that--
            ``(i) reduces the craving for an illegal drug for an 
        individual who--
                    ``(I) habitually uses the illegal drug in a manner 
                that endangers the public health, safety, or welfare; 
                or
                    ``(II) is so addicted to the use of the illegal 
                drug that the individual is not able to control the 
                addiction through the exercise of self-control;
            ``(ii) blocks the behavioral and physiological effects of 
        an illegal drug for an individual described in clause (i);
            ``(iii) safely serves as a replacement therapy for the 
        treatment of abuse of an illegal drug for an individual 
        described in clause (i);
            ``(iv) moderates or eliminates the process of withdrawal 
        from an illegal drug for an individual described in clause (i);
            ``(v) blocks or reverses the toxic effect of an illegal 
        drug on an individual described in clause (i); or
            ``(vi) prevents, where possible, the initiation of abuse of 
        an illegal drug in individuals at high risk.
    ``(C) The term `illegal drug' means a controlled substance 
identified under schedules I, II, III, IV, and V in section 202(c) of 
the Controlled Substances Act (21 U.S.C. 812(c)).''.

SEC. 203. PROTECTION FOR DRUGS.

    Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended--
            (1) in subsection (a), by striking ``rare disease or 
        condition,'' and inserting ``rare disease or condition, or for 
        treatment of an addiction to illegal drugs,'';
            (2) in subsection (b), by striking ``rare disease or 
        condition'' and inserting ``rare disease or condition, or for 
        treatment of an addiction to illegal drugs,'';
            (3) by striking ``such disease or condition'' each place it 
        appears and inserting ``such disease or condition, or treatment 
        of such addiction,''; and
            (4) in subsection (b)(1), by striking ``the disease or 
        condition'' and inserting ``the disease, condition, or 
        addiction''.

SEC. 204. OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS.

    Section 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360dd) is amended--
            (1) by striking ``rare disease or condition'' and inserting 
        ``rare disease or condition, or for treatment of an addiction 
        to illegal drugs,''; and
            (2) by striking ``the disease or condition'' each place it 
        appears and inserting ``the disease, condition, or addiction''.

SEC. 205. CONFORMING AMENDMENTS.

    (a) Subchapter Heading.--The subchapter heading of subchapter B of 
chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa 
et seq.) is amended by striking ``Conditions'' and inserting 
``Conditions, or for Treatment of an Addiction''.
    (b) Section Headings.--The section heading of sections 525 through 
528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aa 
through 360dd) are amended by striking ``conditions'' and inserting 
``conditions, or for treatment of an addiction''.
    (c) Fees.--Section 736(a)(1)(E) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(a)(1)(E)) is amended--
            (1) in the subparagraph heading, by striking ``orphan'';
            (2) by striking ``for a rare disease or condition'' each 
        place it appears and inserting ``for a rare disease or 
        condition, or for treatment of an addiction to illegal 
        drugs,''; and
            (3) in the first sentence, by striking ``rare disease or 
        condition.'' and inserting ``rare disease or condition, or 
        other than for treatment of an addiction to illegal drugs, 
        respectively.''.

 TITLE III--ENCOURAGING PRIVATE SECTOR DEVELOPMENT OF PHARMACOTHERAPIES

SEC. 301. DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE 
              TREATMENT OF ADDICTION TO ILLEGAL DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by adding at the end the following:

        ``Subchapter F--Drugs for Cocaine and Heroin Addictions

``SEC. 571. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR COCAINE AND 
              HEROIN ADDICTIONS.

    ``(a) In General.--Subject to subsections (b) and (c), the 
Secretary shall, in cooperation with the Institute of Medicine of the 
National Academy of Sciences, establish criteria for an acceptable drug 
for the treatment of an addiction to cocaine and for an acceptable drug 
for the treatment of an addiction to heroin. The criteria shall be used 
by the Secretary in making a contract, or entering into a licensing 
agreement, under section 572.
    ``(b) Requirements.--The criteria established under subsection (a) 
for a drug shall include requirements--
            ``(1) that the application to use the drug for the 
        treatment of addiction to cocaine or heroin was filed and 
        approved by the Secretary under this Act after the date of 
        enactment of this section;
            ``(2) that a performance based test on the drug--
                    ``(A) has been conducted through the use of a 
                randomly selected test group that received the drug as 
                a treatment and a randomly selected control group that 
                received a placebo; and
                    ``(B) has compared the long term differences in the 
                addiction levels of control group participants and test 
                group participants;
            ``(3) that the performance based test conducted under 
        paragraph (2) demonstrates that the drug is effective through 
        evidence that--
                    ``(A) a significant number of the participants in 
                the test who have an addiction to cocaine or heroin are 
                willing to take the drug for the addiction;
                    ``(B) a significant number of the participants in 
                the test who have an addiction to cocaine or heroin and 
                who were provided the drug for the addiction during the 
                test are willing to continue taking the drug as long as 
                necessary for the treatment of the addiction; and
                    ``(C) a significant number of the participants in 
                the test who were provided the drug for the period of 
                time required for the treatment of the addiction 
                refrained from the use of cocaine or heroin, after the 
                date of the initial administration of the drug on the 
                participants, for a significantly longer period than 
                the average period of refraining from such use under 
                currently available treatments (as of the date of the 
                application described in paragraph (1)); and
            ``(4) that the drug shall have a reasonable cost of 
        production.
    ``(c) Review and Publication of Criteria.--The criteria established 
under subsection (a) shall, prior to the publication and application of 
such criteria, be submitted for review to the Committee on the 
Judiciary, and the Committee on Education and the Workplace, of the 
House of Representatives, and the Committee on the Judiciary, and the 
Committee on Labor and Human Resources, of the Senate. Not later than 
90 days after notifying each of the committees, the Secretary shall 
publish the criteria in the Federal Register.

``SEC. 572. PURCHASE OF PATENT RIGHTS FOR DRUG DEVELOPMENT.

    ``(a) Application.--
            ``(1) In general.--The patent owner of a drug to treat an 
        addiction to cocaine or heroin, may submit an application to 
        the Secretary--
                    ``(A) to enter into a contract with the Secretary 
                to sell to the Secretary the patent rights of the owner 
                relating to the drug; or
                    ``(B) in the case in which the drug is approved 
                under section 505 by the Secretary for more than 1 
                indication, to enter into an exclusive licensing 
                agreement with the Secretary for the manufacture and 
                distribution of the drug to treat an addiction to 
                cocaine or heroin.
            ``(2) Requirements.--An application described in paragraph 
        (1) shall be submitted at such time and in such manner, and 
        accompanied by such information, as the Secretary may require.
    ``(b) Contract and Licensing Agreements.--
            ``(1) Requirements.--The Secretary may enter into a 
        contract or a licensing agreement described in subsection (a) 
        with a patent owner who has submitted an application in 
        accordance with subsection (a) if the drug covered under the 
        contract or licensing agreement meets the criteria established 
        by the Secretary under section 551(a).
            ``(2) Special rule.--The Secretary may, under paragraph 
        (1), enter into--
                    ``(A) not more than 1 contract or exclusive 
                licensing agreement relating to a drug for the 
                treatment of an addiction to cocaine; and
                    ``(B) not more than 1 contract or licensing 
                agreement relating to a drug for the treatment of an 
                addiction to heroin.
            ``(3) Coverage.--A contract or licensing agreement 
        described in subparagraph (A) or (B) of paragraph (2) shall 
        cover not more than 1 drug.
            ``(4) Purchase amount.--Subject to amounts provided in 
        advance in appropriations Acts--
                    ``(A) the amount to be paid to a patent owner who 
                has entered into a contract or licensing agreement 
                under this subsection relating to a drug to treat an 
                addiction to cocaine shall not exceed $100,000,000; and
                    ``(B) the amount to be paid to a patent owner who 
                has entered into a contract or licensing agreement 
                under this subsection relating to a drug to treat an 
                addiction to heroin shall not exceed $50,000,000.
    ``(c) Transfer of Rights Under Contracts and Licensing Agreement.--
            ``(1) Contracts.--A contract under subsection (b)(1) to 
        purchase the patent rights relating to a drug to treat cocaine 
        or heroin addiction shall transfer to the Secretary--
                    ``(A) the exclusive right to make, use, or sell the 
                patented drug within the United States for the term of 
                the patent;
                    ``(B) any foreign patent rights held by the patent 
                owner with respect to the drug;
                    ``(C) any patent rights relating to the process of 
                manufacturing the drug; and
                    ``(D) any trade secret or confidential business 
                information relating to the development of the drug, 
                process for manufacturing the drug, and therapeutic 
                effects of the drug.
            ``(2) Licensing agreements.--A licensing agreement under 
        subsection (b)(1) to purchase an exclusive license relating to 
        manufacture and distribution of a drug to treat an addiction to 
        cocaine or heroin shall transfer to the Secretary--
                    ``(A) the exclusive right to make, use, or sell the 
                patented drug for the purpose of treating an addiction 
                to cocaine or heroin within the United States for the 
                term of the patent;
                    ``(B) the right to use any patented processes 
                relating to manufacturing the drug; and
                    ``(C) any trade secret or confidential business 
                information relating to the development of the drug, 
                process for manufacturing the drug, and therapeutic 
                effects of the drug relating to use of the drug to 
                treat an addiction to cocaine or heroin.

``SEC. 573. PLAN FOR MANUFACTURE AND DEVELOPMENT.

    ``(a) In General.--Not later than 90 days after the date on which 
the Secretary purchases the patent rights of a patent owner, or enters 
into a licensing agreement with a patent owner, under section 572, 
relating to a drug under section 571, the Secretary shall develop a 
plan for the manufacture and distribution of the drug.
    ``(b) Plan Requirements.--The plan shall set forth--
            ``(1) procedures for the Secretary to enter into licensing 
        agreements with private entities for the manufacture and the 
        distribution of the drug;
            ``(2) procedures for making the drug available to nonprofit 
        entities and private entities to use in the treatment of a 
        cocaine or heroin addiction;
            ``(3) a system to establish the sale price for the drug; 
        and
            ``(4) policies and procedures with respect to the use of 
        Federal funds by State and local governments or nonprofit 
        entities to purchase the drug from the Secretary.
    ``(c) Applicability of Procurement and Licensing Laws.--Federal law 
relating to procurements and licensing agreements by the Federal 
Government shall be applicable to procurements and licenses covered 
under the plan described in subsection (a).
    ``(d) Review of Plan.--
            ``(1) In general.--Upon completion of the plan under 
        subsection (a), the Secretary shall notify the Committee on the 
        Judiciary, and the Committee on Education and the Workplace, of 
        the House of Representatives, and the Committee on the 
        Judiciary, and the Committee on Labor and Human Resources, of 
        the Senate, of the development of the plan and publish the plan 
        in the Federal Register. The Secretary shall provide an 
        opportunity for public comment on the plan for a period of not 
        more than 30 days after the date of the publication of the plan 
        in the Federal Register.
            ``(2) Final plan.--Not later than 60 days after the date of 
        the expiration of the comment period described in paragraph 
        (1), the Secretary shall publish in the Federal Register a 
        final plan described in subsection (a). The implementation of 
        the plan shall begin on the date of the publication of the 
        final plan.
    ``(e) Construction.--The development, publication, or 
implementation of the plan, or any other agency action with respect to 
the plan, shall not be considered agency action subject to judicial 
review. No official or court of the United States shall have power or 
jurisdiction to review the decision of the Secretary on any question of 
law or fact relating to any agency action with respect to the plan.
    ``(f) Regulations.--The Secretary may promulgate regulations to 
carry out this section.

``SEC. 574. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated to carry out this 
subchapter, such sums as may be necessary in each of the fiscal years 
1999 through 2001.''.

Summary: TABLE OF CONTENTS: Title I: Pharmacotherapy Research Title II: Patent Protections for Pharmacotherapies Title III: Encouraging Private Sector Development of Pharmacotherapies New Medications to Treat Addiction Act of 1998 - Title I: Pharmacotherapy Research - Amends the Public Health Service Act to authorize appropriations as necessary to carry out provisions relating to development of medications to treat drug addiction, allowing specified sums of those amounts to be appropriated from the Violent Crime Reduction Trust Fund. Title II: Patent Protections for Pharmacotherapies - Amends the Federal Food, Drug, and Cosmetic Act to add references to drugs for the treatment of addiction to illegal drugs to provisions relating to drugs for rare diseases or conditions, allowing exclusive approval, certification, or licensure, subject to exception. Requires that the sponsor of such a treatment drug be encouraged to design open protocols. Title III: Encouraging Private Sector Development of Pharmacotherapies - Mandates establishment of criteria for an acceptable drug for the treatment of addiction to cocaine and an acceptable drug for the treatment of addiction to heroin. Allows the patent owner of a drug to treat cocaine or heroin addiction to apply to the Secretary of Health and Human Services to sell the patent rights to, or make an exclusive licensing agreement with, the Secretary. Sets the purchase amount at $100 million for the cocaine treatment drug and $50 million for the heroin treatment drug. Directs the Secretary, after the sale or licensing, to develop a manufacturing and distribution plan. Authorizes appropriations to carry out this title.