Pharmacotherapy Development Act of 1996

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmacotherapy Development Act of 
1996''.

   TITLE I--DEVELOPMENT OF DRUGS FOR THE TREATMENT OF ADDICTIONS TO 
                             ILLEGAL DRUGS

SEC. 101. 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) by striking ``States'' each place it appears and 
        inserting ``States, or for treatment of an addiction to illegal 
        drugs''; and
            (2) by striking ``such disease or condition'' each place it 
        appears and inserting ``such disease, condition, or treatment 
        of such addiction''.

SEC. 102. 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,''; and
                    (C) by striking ``such disease or condition'' each 
                place it appears and inserting ``such disease, 
                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 thereof the following new 
                subparagraphs:
    ``(B) The term `treatment of an addiction to illegal drugs' means 
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 drug abuse for an individual described in clause 
        (i);
            ``(iv) moderates or eliminates the process of withdrawal 
        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 drug 
        abuse 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 Substance Act (21 U.S.C. 812(c)).''.

SEC. 103. PROTECTION FOR DRUGS.

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

SEC. 104. 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''.

 TITLE II--DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE 
               ADDICTION OF COCAINE AND HEROIN ADDICTIONS

SEC. 201. DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE 
              TREATMENT OF ADDICTIONS 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 thereof the following new 
subchapter:

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

``SEC. 551. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR COCAINE AND 
              HEROIN ADDICTIONS.

    ``(a) In General.--Subject to the provisions of subsections (b) and 
(c), the Secretary shall, through 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 to a licensing 
agreement, under section 552.
    ``(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 for a 
                period of 3 years after the date of the initial 
                administration of the drug on the participants; 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 Economic and Educational Opportunities 
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. 552. 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 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 Agreement.--
            ``(1) Requirements.--The Secretary shall enter into a 
        contract or a licensing agreement with a patent owner who has 
        submitted an application in accordance with (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 shall 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.
        A contract or licensing agreement described in subparagraph (A) 
        or (B) shall cover not more than 1 drug.
            ``(3) Purchase amount.--Subject to appropriations--
                    ``(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 be $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 be $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;
                    ``(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. 553. 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, relating to a drug 
under section 551, 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.--The 
procurement and licensing laws of the United States 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 Economic and Educational 
        Opportunities 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. The implementation of the plan shall begin on the 
        date of the final publication of the 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.
    ``(f) Regulations.--The Secretary may promulgate regulations to 
carry out this section.

``SEC. 554. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated to carry out this 
subchapter, such sums as may be necessary in each of the fiscal years 
1997 through 1999.''.

Summary: TABLE OF CONTENTS: Title I: Development of Drugs for the Treatment of Addictions to Illegal Drugs Title II: Development, Manufacture, and Procurement of Drugs for the Addiction (sic) of Cocaine and Heroin Addictions Pharmacotherapy Development Act of 1996 - Title I: Development of Drugs for the Treatment of Addictions to Illegal Drugs - 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 II: Development, Manufacture, and Procurement of Drugs for the Addiction (sic) of Cocaine and Heroin Addictions - Requires that the Institute of Medicine of the National Academy of Sciences establish 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.