The Development of Medications for the Treatment of Opiate and Cocaine Addictions Issues for the Government and Private Sector (1995) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-25
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There is still no approved medication for the treatment of cocaine addiction. During the same 30 year period, however, serious medical and social problems have evolved as drug addiction has become a route for spreading the acquired immune deficiency syndrome (AIDS)
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As a result of the committee's deliberations, meetings, and workshop, it became evident that the major disincentives to pharmaceutical R&D for antiaddiction medications include: an inadequate science base on addiction and the prevention of relapse (especially for cocaine) ; an uncertain market environment which includes such issues as: treatment financing, lack of trained specialists for the treatment of drug addiction, federal and state regulations, market size, pricing issues, societal stigma, liability issues, difficulties in conducting clinical research; and a lack of sustained federal leadership.
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Because the state of scientific knowledge of addiction is rudimentary, the committee believes that it is imperative to foster NIDA's basic-research efforts in the mechanism of cocaine addiction and in the molecular, cellular, and behavioral bases of chronic drug effects and the genetics of vulnerability to addiction. There is also a need for basic research to develop laboratory models of behavioral characteristics of the addictive process.
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The committee is aware, however, of the budget constraints on the institutes of the National Institutes of Health (NIH) ; as a possible mechanism for increased support, the committee suggests the use of funds from the Special Forfeiture Fund in the Office of National Drug Control Policy (ONDCP)
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NIDA'S MEDICATIONS DEVELOPMENT DIVISION In recognition of the need to stimulate the availability of medications to treat drug addiction, the Anti-Drug Abuse Act of 1988 (P.L.
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Consequently, it should be empowered to lead, as well as to fulfill, a scientific and technical mission. The committee recommends that NIDA and MDD, in determining how to improve MDD's relationship with industry, evaluate the applicability of the techniques already in use by the Developmental Therapeutics Program of the National Cancer Institute, the National Cooperative Drug Discovery Groups on Acquired Immune Deficiency Syndrome of the National Institute of Allergy and Infectious Disease, and the Anticonvulsant Drug Development Program of the National Institute of Neurological Disorders and Stroke.
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Currently the financing of methadone treatment is deeply dependent on the public sector, primarily in the form of federal block grants and state alcohol and drug agency funds. Despite the sizeable public role in financing, neither state agencies or the federal government have 3Financing is generally defined as the payment or reimbursement for the cost of treatment made by private insurance, Medicaid, the patients themselves, or other sources.
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State financing practices can be so rigid that they effectively block the introduction and adoption of a new medication. The flow of funds to clinics is dictated by the policies and regulations of two separate state agencies: the state alcohol and drug agency, which administers state funds and federal block grants, and the state Medicaid agency, which administers state and federal Medicaid dollars.
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, pharmaceutical companies see greater difficulty in marketing anti-addiction medications than in marketing other products. Pharmaceutical firms also rely on academic clinical investigators and practicing clinicians to advise them on drug development issues such as current therapeutic trends, the role of drugs in the overall treatment strategy, unmet medical needs, indications to be evaluated, clinical trial design, and appropriate therapeutic endpoints.
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. Mid-career programs could be developed to encourage a cadre of practicing physicians and scientists to enter the field of drug addiction treatment and research.
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As an incentive to the pharmaceutical industry and because drug addiction should qualify as a serious and life-threatening disease, The committee recommends that FDA make the treatment-IND route, the parallel-track mechanism, and accelerated approval available for anti-addiction medications.
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The committee recommends that DEA review time be counted as part of the regulatory process for purposes of patent term extension for controlled substances.5 To accomplish this, any of the following three options could be implemented: · Amend the Drug Price Competition and Patent Term Restoration Act (DPC-PTR)
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The committee recommends that action be taken to remove the adverse effects of DEA requirements, under the CSA, on clinical research investigations involving controlled substances, by holders of active FDA INDs, either by amending the CSA to exempt such investigations from applicable DEA regulations or by the alternative administrative and regulatory measures: · The development of a Memorandum of Understanding between FDA and DEA governing the matter of dual authority over clinical research to provide exemption from DEA reporting requirements. · DEA revision of 21 CFR 1301.33 and parallel regulations to provide that protocols, drug security, recordkeeping, production controls, reporting, and other requirements would be governed by the FDA regulations and monitored by FDA.
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State and federal controlled substances acts are designed primarily to govern the possession, use, sale, distribution, and manufacture of medications that have a potential for abuse. Most state CSAs contain regulatory mechanisms, terminology, and provisions similar to those contained in the federal CSA; although, there are significant differences between federal provisions and states' provisions and variations in statutes from one state to another (NCJA, 1991~.
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The committee recommends that the Office of National Drug Control Policy (ONDCP) direct DEA, in consultation with FDA and NIDA, to revise its policy on determining when a drug has a currently accepted medical use in treatment so that, for new therapeutic drugs that are also controlled substances, the process of scheduling can begin as soon as possible after submission of the NDA.
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To implement that recommendation, the following steps may be taken: · Conduct a comprehensive study of state laws and regulations pertinent to the development of anti-addiction medications that are controlled substances, and develop a step-by-step manual for pharmaceutical companies explaining the mechanisms involved in launching an anti-addiction medication.
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The committee does believe, however, that the initiative for reform must come from the federal government, and will have to involve some form of legislative change. The committee recommends, on the basis of the comprehensive study recommended above, that ONDCP, in coordination with other relevant federal agencies, develop a series of specific actions encouraging states to reform their laws and regulations to facilitate the availability of new anti-addiction medications that are controlled substances.6 Those actions should give particular attention to: · Modifying state laws and regulations for narcotic treatment programs to remove the need to reopen and amend the laws or regulations to accommodate each new product.
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The pharmaceutical industry appears willing to invest in R&D for markets that are smaller in size or approximately the same size as the cocaine user market, yet reluctant to enter the field of anti-addiction products. There are several reasons for this apparent paradox.
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It is illogical and counterproductive to the purposes of the Orphan Drug Act to count those patients against the 200,000 threshold. The committee recommends that FDA interpret the Orphan Drug Act broadly with the intent of granting orphan drug status to FDAapproved anti-addiction medications whose potential market can reasonably be judged to meet the 200,000 patient criterion stipulated by law.
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Such pricing provisions are also included in NIH exclusive licensing agreements. The potential impact of CRADAs on pricing of products aIld patent rights has been an important issue of concern for the pharmaceutical industry.
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This lack of federal leadership represents an additional disincentive to industry, in that it affects the public sector's ability to establish clear guidelines, enhance interagency cooperation, and provide research programs with the stability necessary for medication discovery and development (Chapter 9~. In addition to its role in developing medications for drug addiction, the government is likely to be the major purchaser of those medications.
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The formidable scientific and marketing issues, regulatory complexities, and financial uncertainties add up to an unattractive picture to the pharmaceutical industry, which tends to enter R&D investment from a high risk-high reward perspective. Although it is possible to envision incentives that would interest some pharmaceutical companies (e.g., small pharmaceutical companies, biotechnology companies, or those companies already involved in the development of CNS compounds)
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The removal of disincentives includes many of the committee's administrative recommendations: use of orphan drug and fast track mechanisms for antiaddiction compounds; removal of adverse effects on clinical research of DEA requirements under the Controlled Substances Act; and counting DEA review time as part of the regulatory process for purposes of patent term extension for controlled substances. The creation of modest incentives should include broad interpretation of the Orphan Drug Act to include anti-addiction medications or similar legislation to stimulate the market in the development of anti-addiction medications; a strong federal leadership role in support of treatment of drug-dependent patients; funding of basic research and training; adequate funding of treatment; and a modification or elimination of the "reasonable pricing clause" in CRADAs.
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1991. Guide to State Controlled Substances Acts.
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1993. The Orphan Drug Act: should it be changed?
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