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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3 Assessment of the Medications Development Division
3 Assessment of the Medications Development Division
Pages 74-94
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From page 74... ...
. STRUCTURE AND FUNCTIONS OF THE MEDICATIONS DEVELOPMENT DIVISION Mission and History In recognition of the need to stimulate the availability of medications to treat drug addiction, the Anti-Drug Abuse Act of 1988 (Public Law 100-690)
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From page 75... ...
1993 and $95 million in FY 1994, although actual funding has been only about one-third of the authorization. The primary strategy adopted by MDD is to work with industry to perform the research and development necessary to secure FDA marketing approval for new medications to treat drug addiction.
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From page 76... ...
committee accepts this justification and current emphasis of MDD on opiate and cocaine addictions; although the committee recognizes that the two addictive drugs that are most important with respect to morbidity, mortality, and economic costs are alcohol and nicotine. Program Objectives MDD's mission statement describes its program objective: the development of new medications to treat drug addiction.
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From page 77... ...
Cocaine Treatment Clinical Program. As an example, the Cocaine Treatment Discovery Program attempts to acquire at least 200 chemicals each year from the pharmaceutical industry and other sources.
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From page 78... ...
MDD has no internal laboratory or clinical research capabilities, so virtually all its budget is spent on grants, contracts, and interagency agreements aimed at drug development. In general, about half the MDD budget is devoted to grants and the other half to contracts (which include interagency agreements)
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From page 79... ...
. In terms of funding, however, the MDD budget constitutes approximately 80 percent of the Medications Development Program.
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From page 80... ...
In FY 1993, about half the total contract budget of $18.5 million was spent on R&D contracts and the other half on interagency agreements. Interagency Agreements Through interagency agreements with the DVA Cooperative Studies Program, MDD has gained the capacity to undertake large-scale Phase III clinical trials.
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From page 81... ...
For example, the commercial sponsor might obtain exclusive marketing of a new psychoactive compound for the treatment of depression, as well as for drug addiction. Thus far, MDD has succeeded in negotiating two CRADAs with industry partners, both for potential treatments for cocaine addiction: one for Phase II clinical research on gepirone with Bristol Myers Squibb, and the other for Phase II research for bupropion with Burroughs Wellcome.
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From page 82... ...
This is a general professional problem related to the relative isolation of treatment of drug abuse from the mainstream of academic medicine and medical practice, the personal health risks of working with patients who often have such other serious illnesses as HIV infection or tuberculosis, the difficulties of conducting high-quality clinical research in the social environment in which the bulk of addiction occurs, the perceived low respectability of the field, and the involvement of many patients with crime or the criminal justice
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From page 83... ...
. This program would be administered through FDA's Staff College and would provide stipends for 9-12 clinicians to receive 3 years of training through rotations at three federal programs: MDD, the FDA Pilot Drug Evaluation staff, and the NIDA Addiction Research Center.
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From page 84... ...
FDA and NIDA also participate in the process for scheduling drugs of abuse arid in the promulgation of regulations on treatment standards for the use of narcotics in treating drug addiction. Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, the secretary of DHHS must issue regulations that describe how any new narcotic medication can be administered and used in narcotic treatment programs.
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From page 85... ...
In arranging for the recent LAAM study, obtaining IRB approval of individual study sites became unusually complex, primarily because LAAM was, until it was approved by FDA, a Schedule I substance under the Controlled Substances Act. It is useful to note these complexities in some detail because they illustrate the procedural problems that make clinical research on anti-addiction compounds difficult; they will complicate future clinical trials involving narcotics unless new policy solutions can be found.
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From page 86... ...
Because LAAM was a Schedule I substance, however, an additional set of procedural requirements driven by the Controlled Substances Act came into play: multiple reviews of the protocol to ensure that it met the scientific requirements of FDA; the DEA regulations related to recordkeeping, security, and diversion; the methadone regulation of DHHS; and the counterpart narcotic regulations of each state that contained a participating clinic. The MDD staff estimates that about 15 drafts of the protocol, with iterative consultation and agreement, were necessary.
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From page 87... ...
A technical subcommittee of CDDA has provided information about methods for clinical and statistical design that are often used in medica tion-development clinical trials. ASSESSMENT OF THE MEDICATIONS DEVELOPMENT DIVISION MDD has made considerable progress in the 4 years since its inception.
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From page 88... ...
Clinical Trials The committee commends MDD for completing the development of LAAM and recognizes that MDD analyzed a file of accumulated data on some 6,300 patients and negotiated with FDA a final Phase III clinical trial necessary for LAAM's approval. The committee is impressed that MDD has gained invaluable experience and built an effective clinical-investigator network and administrative base that can be used for the conduct of Phase III studies on other anti-addiction drugs.
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From page 89... ...
As discussed earlier, the appeal of this field is limited by the stigma of drug addiction, the noncompliance of drug-dependent individuals as subjects in clinical trials, the risk of infectious diseases that afflict these patients, and the general lack of insurance coverage for drug-abuse treatment. The lack of clinical research and treatment centers has and will continue to have an impact on MDD's ability to carry out sophisticated clinical studies of pharmacological and other treatments ~.
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From page 90... ...
The LAAM clinical trial was delayed by 3 - months because of the time DEA required to inspect each of the 24 separate research sites before this Schedule I narcotic could be dispensed in a clinical protocol. Another major obstacle to drug development is the extraordinary degree of regulation surrounding a treatment after it is approved for marketing.
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From page 91... ...
The second explanation has been industry discontent with the screening agreement developed by MDD to obtain chemicals for testing. Although the screening agreement assures commercial sponsors the intellectual property rights, the unresolved legal issues between NIH and Burroughs Wellcome over patenting of the AIDS treatment zidovudine (AZT)
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From page 92... ...
Nevertheless, it is the opinion of the committee that NIDA can address some of those issues in the context of its current operations: it can increase emphasis on leadership of a public-private cooperative effort, increase emphasis on the early evaluation of promising compounds in clinical pharmacology and early Phase II studies, and create an investigator network that is available to the private sector for Phase III studies. All those moves are aimed at improving NIDA's and MDD's leadership role, management, and strategies for screening.
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From page 93... ...
an uncertain market environment, including the treatment setting (Chapter 4~; treatment financing (Chapter 5~; lack of trained specialists for drug addiction treatment and research (Chapter 6~; federal and state laws and regulations (Chapters 7 and 8~; and market size; pricing issues, societal stigma, liability issues, and difficulties in conducting clinical research (Chapter 9~; and · a lack of sustained federal leadership (Chapter 9~.
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From page 94... ...
1992. National Institute on Drug Abuse Medications Development Program 5 Year Strategic Plan.
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