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8 State Laws and Regulations State laws and regulations affect the discovery, development, and marketing of anti-addiction medications, especially if the medication is a controlled substance. Current medications to treat opiate addiction (methadone and levo- alpha-acetylmethadol or LAAM) are Schedule II narcotics that are tightly regulated, not only under the federal Controlled Substances Act (CSA; P.~. 91- 51 3) and the Narcotic Addict Treatment Act (NATA; P.L. 93-28 1 ~ but also under companion state laws. All states and the District of Columbia have regulations that are counterparts to the comprehensive federal regulatory structure for controlled substances (Chapter 7~. Rather than set the upper boundaries of state regulation, federal laws and regulations establish minimum requirements above which states may impose stricter or additional requirements. As a result, there are significant variations in statutes from state to state, and numerous differences between federal and state provisions (NCJA, 1991~. If the medications being developed are controlled substances, state laws can have as great a practical effect as the federal laws. This chapter examines the effect of state laws and regulations on the use of controlled substances in research and treatment, and it discusses the effects of state laws and regulations on private-sector development of new anti-addiction medications that are controlled substances. 173

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174 DEVELOPMENT OF MEDICATIONS STATE REGULATORY LANDSCAPE State and federal controlled substances acts (CSAs) 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. During the discovery and development of any drug, pharmaceutical companies must interact continuously with the relevant federal agencies. Additional federal interactions are required when developing a Schedule I or II narcotic (Chapter 7), and pharmaceutical companies developing such products also are faced with the regulatory authority of each state. Some states have established comprehensive laws and regulations for controlled substances that address scheduling and rescheduling of medications; the conduct of clinical research (including researcher registration, clinic licensure, clinical trial protocol approvals); registrations and licenses for manufacturers, distributors, prescribers, and dispensers; the administration of treatment centers (including approval and registration, record keeping, administrative policies and procedures, product storage, and licensing of practitioners); and restriction on dispensing, labeling, and advertising. A failure to understand the regulatory framework in each state can lead to significant delays in clinical research development, marketing and use of a new anti-addiction medication, as shown by the LAAM case study presented later in this chapter. Any perceived delay in a return on investment to a pharmaceutical company can influence the decision to develop a new anti- addiction medication. Inasmuch as this area is already perceived as a marginal business investment, the additional overlay of the state laws and regulations and the resulting delays can negatively influence manufacturers' decisions to enter the field. The following sections present an overview of a range of selected state regulations that affect anti-addiction medications development. State scheduling, treatment, and clinical research regulations are described. Scheduling The federal CSA places all substances into one of five schedules (Chapter 7~. Placement is based on the substance's medical efficacy, safety, potential for abuse and diversion, and physical and psychological dependence liability; substances placed in one schedule can be rescheduled (21 USC 811) as new information becomes available. Although some states have adopted schedules identical to the federal schedules (basing their action on the uniform model developed by the National Conference of Commissioners on Uniform State Laws), some reschedule

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STATE LA US AND REGULATIONS 175 controlled substances independently of the federal government and more restrictively. The process of state scheduling of new drugs and revising the schedules of existing drugs occurs in three ways: automatic rescheduling, administrative rule-making, or, in many states, by new legislation. In any case, the process does not usually begin until a drug has been scheduled or rescheduled at the federal level (Chapter 71. In many states (including Texas, Illinois, and New Jersey), the scheduling .. procedure is triggered automatically by a federal scheduling determination, and the medication is presumptively placed into the same schedule as the federal schedule. The entire process can be accomplished in about 30 days. In those states,-however, public hearings can be held in case of objections, often slowing the process. In other states (including Pennsylvania, New York, California), there is no formal linkage between the state scheduling process and the federal process, nor is there any time limit on the state scheduling process. In those states, independent action by a state body (either a state regulatory agency or the state legislature) is necessary to begin the scheduling process. States differ as to whether the legislature or a regulatory agency (or both) is primarily responsible for scheduling. For example, in South Carolina, Rhode Island, and Tennessee the scheduling determination is made by a regulatory agency (usually with an explicit provision for a legislative override); in New York and California, state legislative action is required. In other states (Iowa, Hawaii, Mississippi), the legislature and the state regulatory agencies are involved in the scheduling and rescheduling process. Variations in the scheduling process can have a substantial effect on the marketing of a new medication. The fact that each state has its own scheduling mechanism creates a daunting set of tasks for prospective manufacturers. The potential for serious delay is real, particularly in states that require legislative action, because not all state legislatures meet in continuous session (for example, in 1994 only 38 state legislatures met in regular session). Such delays add a significant obstacle to pharmaceutical companies in calculating a return on the initial investment. In particular, the LAAM scheduling experience could dissuade companies as they consider developing portfolios of future anti-addiction medications (see LAAM case study below). While state inactivity is rescheduling can result in long delays in moving a drug from schedule I (under state Controlled Substances Acts) to schedules II to V, this situation is brought about in part by the current federal policy of interpreting "currently accepted medical use in treatment in the United States" (for purposes of scheduling under the Controlled Substances Act) as requiring NDA (new drug application) approval. A consequence of this policy is that the regulatory process at the federal level is prolonged for all newly approved drugs that are controlled substances (Chapter 7~; this regulatory delay can become years when the rescheduling process requires both state and federal action and cannot

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176 DEVELOPMENT OF MEDICATIONS begin until NDA approval, e.g., LAAM. The committee believes that the public health would be best served by an interpretation of the "currently accepted medical use" clause in the Controlled Substances Act that would recognize the use in humans under an IND (investigational new drug) and permit the scheduling process to begin at the time of NDA submission. The information required for scheduling a drug is already required to be in a self-contained section of the NDA. That section could be reviewed on a fast-track basis by the Food and Drug Administration (FDA), and a scheduling recommendation could be sent to the Drug Enforcement Administration (DEA) well ahead of NDA approval. Scheduling could be done contingent upon final FDA approval. That approach would permit states to reschedule schedule I drugs closer in time to final FDA approval, minimizing delays such as the one now affecting LAAM, and have no negative drug control implications. Furthermore, it would remove a significant regulatory disincentive at the federal level that affects all scheduled drugs, not just schedule I substances. The committee recommends that the Office of National Drug Control Policy (ONDCP) direct DEA, in consultation with FDA and the National Institute on Drug Abuse (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. Treatment Each state is responsible for approving narcotic treatment programs and for monitoring those programs for compliance with state regulations. State treatment regulations must be at least as restrictive as federal regulations, but more stringent regulations are allowed. State approval of narcotic treatment programs is a prerequisite for federal approval, and individual states can recommend to the FDA that a program's approval be revoked for noncompliance [21 CFR 291.505(h)~21] (SAMHSA, 19921.~ Any new anti-addiction medication that is tin that case, FDA's Center for Drug Evaluation and Research (CDER) will notify the treatment program, which will be given the opportunity to respond in an informal hearing or in writing within 10 days [21 CFR 291 .505(h)~2~. If the explanation offered is unacceptable, the FDA commissioner must provide the opportunity for a hearing, render a decision, and notify all appropriate authorities, including the state [21 CFR 291.505(h)~3~. FDA, however, has no authority to grant an appeal if the revocation is based on state law or regulation [21 CFR 291.505(h)~5~.

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STATE LAWS AND REGULATIONS 177 a narcotic will be required, under federal regulations, to be distributed through approved narcotic treatment programs. The states must not only schedule or reschedule the new medication, but they must also amend their treatment regulations to accommodate the new product before granting approval for its use in treatment. Until recently, methadone was the only medication approved for use in narcotic treatment programs, and state regulations were written only for methadone maintenance treatment. Once a new anti-addiction medication receives FDA approval for the treatment of drug dependence, the states must amend their methadone regulations before it is used in a program. Thus, under the current regulatory landscape, there could be substantial delays before arty newly approved anti-addiction medication actually reaches the patient population. In fact, not even methadone maintenance therapy is available in all states (SAMHSA, 1992~. A sample of state treatment regulations, discussed below, illustrates the complexities faced by pharmaceutical companies as they determine the feasibility of developing a new medication and the probability of success that a new anti- addiction medication will deliver an adequate return on investment. Admission Criteria In California, individuals may not be admitted to a narcotic maintenance treatment program unless they are currently addicted, have a 2-year addiction history, and possess evidence of two earlier failures in withdrawal treatments other than with methadone [California Code of Regulations, Title 9 l 0270(b)~. California also imposes a 2-year limit on treatment unless a physician certifies that additional treatment is medically necessary [California Code of Regulations, Title 9 10410a. In practice, almost all programs routinely receive permission to exceed this limitation. By contrast, federal regulations require only a 1-year history of addiction, which is the norm in other states, such as New York t21 CFR 291.505(d)~1~(i)~. New York also requires documented proof that a prospective patient has attempted detoxification or drug-free treatment at least twice [New York Compilation of Codes, Rules, and Regulations, Title 14 1 040.5(d)~. Staffing Requirements State staffing requirements for narcotic treatment programs span a wide range of approaches. New York specifies that each program employ one full-time physician for every 300 patients. Two full-time nurses are required for the first

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178 DEVELOPMENT OF MEDICATIONS 300 patients, and thereafter another full-time nurse is needed for each additional 100 patients or fraction thereof. One full-time case worker is required to counsel every 50 patients (New York Compilation of Codes, Rules, and Regulations, Title 14 1040.15~. California requires one physician for every 200 patients in a maintenance program, and one counselor for every 40 patients [California Code of Regulations, Title 9 lOlOO(b)~. Massachusetts requires one full-time Physician or nurse for the first 300 patients, and one nurse or physician's assistant for each additional 300 patients (Massachusetts Bureau of Substance Abuse Services, no date given). All clinics are required by federal regulations to have a licensed physician serve as the designated medical director (21 CFR 291.505~. Patient Registries To prevent illegal diversion of controlled medications, the federal govern- ment prohibits treatment programs from administering medications, except in an emergency situation, to "a patient who is known to be currently receiving drugs from another treatment program," and requires that patients always report to the same treatment facility, unless permission is granted otherwise [21 CFR 291.505(e)~. New York requires the maintenance of a central registry system. Before a patient is enrolled in a treatment program, the patient's name must be submitted to a central registry, which also has information regarding patient discharges and transfers from other treatment programs (New York Compilation of Codes, Rules, and Regulations, Title 14 1040.4~. Florida has a provision [Florida Administrative Code Rule lOE-16.003~5~] similar to New York's central registry. California attempts to prevent multiple enrollments in treatment programs through the use of a statewide database of methadone treatment participants against which prospective patients are checked (California Code of Regulations, Title 9 102201. If a prospective patient's initial drug screen tests positive for methadone, it is the responsibility of the treatment program's administrator to contact all other programs within a 50-mile radius (California Code of Regulations, Title 9 10215~. Drug Screening Federal regulations, after initial screening, require eight random urine tests during the first year of maintenance therapy and one random test per quarter during each subsequent year. Patients who take home medications, however, must be screened monthly [21 CFR 291.505(d)~21(i)~. By comparison, New York requires urine testing each week during the first 3 months of treatment. If the

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STATE LAWS AND REGULATIONS 179 testing shows no evidence of drug abuse, the patient need be tested only once a month [New York Compilation of Codes, Rules, and Regulations, Title 14 1040.123. Monthly drug screening is the rule in California [California Code of Regulations, Title 9 103 lopers; Massachusetts requires an average of 26 urine screens annually (about once every other week) (Massachusetts Bureau of Substance Abuse Services, no date given). Medication Take-Home Policies Federal law allows a maximum of a 2-day take-home supply of methadone after 3 months of treatment; LAAM has not yet been approved for take-home use (Chapter 5~. A 3-day supply can be given to a patient who has participated in a treatment program, adhering to all its rules, for 2 years; after 3 years, a 6-day take-home supply is allowed [21 CFR 291.505(d)~6~(v)~. Many states, however, take a stricter approach. For example, California regulations allow a 1-day take- home supply of medications after the first 3 months, but the maximum is a 3-day supply after 2 years [California Code of Regulations, Title 9 1 0375(b)~. Florida and Illinois also add further restrictions to the federal take-home policy (Florida Administrative Code Rule lOE-16.014~3~(d); Illinois Administrative Code 2058.359~. In Illinois a patient may not receive more than a 3-day take-home supply without a written exemption from the Department of Alcoholism and Substance Abuse (Illinois Administrative Code 2058.359~. Clinical Research Clinical research with potential new medications follows a prescribed course outlined by the FDA's IND process, and clinical trials with medications that are not controlled substances may be conducted in any state with little or no added state regulation. However, additional regulatory steps often are required for clinical trials of controlled substances, which can add further costs and delay the development process. California, for example, requires that an investigator planning to conduct research on human subjects involving a Schedule I or II substance submit the protocol to the state's research advisory panel for approval California Health & Safety Code 11481; Research Advisory Panel, 1993~. Approval is granted for 6 months, although the investigator may request permission to extend the study. Approved research programs are subject to inspection by panel members, staff, or hired consultants, and annual progress and final reports must be submitted to the panel (Research Advisory Panel, 1993) New York similarly requires state approval of clinical research involving Schedule I substances, and state licenses are required for anyone engaging in

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180 DEVELOPMENT OF MEDICATIONS research with a controlled substance generally (New York Public Health Law 3324 to 3329; New York Compilation of Codes, Rules, and Regulations, Title 10 80.36~. The state also imposes record-keeping requirements for researchers who study controlled substances (New York Public Health Law 3329; New York Compilation of Codes, Rules, and Regulations, Title 10 80.37~. LAAM: A CASE STUDY The development of LAAM (marketed in the United States under the trade name ORLAAM), illustrates all too clearly how state regulations can impede the availability of an approved anti-addiction medication. LAAM is a synthetic opiate that suppresses withdrawal symptoms for up to 72 hours with minimal side effects. The main advantage of LAAM is that it is potentially more effective than methadone therapeutically. LAAM has additional advantages, when compared to methadone, such as: it must be taken less frequently (three times per week, as opposed to daily for methadone); it has a longer duration to onset of peak effect; and it produces a less euphoric effect overall. Those characteristics should provide several benefits, including alleviating overcrowding in treatment programs, reducing costs, lowering attractiveness to the illicit drug trade, and offering less potential for diversion. LAAM was approved by FDA in July 1993 for the management of opiate dependence under an NDA sponsored by BioDevelopment Corporation (BDC). BDC has a staff of 29 people, limited financial resources, and LAAM is its only approved product. The final approval of LAAM as an anti-addiction medication was expedited through a major initiative that entailed considerable cooperation and planning among NIDA, DEA, and FDA (Chapter 3~. After FDA approval, DEA rescheduled LAAM on August 18, 1993, from a Schedule I to a Schedule II narcotic under the federal CSA. Under current regulations, LAAM can be distributed only to clinics and hospitals that operate licensed narcotic treatment programs. Since the federal rescheduling of LAAM, BDC has been working with NIDA, FDA, DEA, Substance Abuse and Mental Health Services Administration (SAMHSA), and the 40 states with approved methadone treatment programs to make LAAM available to the patient population. Given the advantages of LAAM (i.e., it is potentially more effective therapeutically than methadone) one would conclude that narcotic treatment programs, and the states that support them, would be eager to make LAAM available to their patient populations. However, as of October 1994, fewer than 1,000 patients nationwide had received LAAM; its availability has been severely limited by laws and regulations, financing, and the approval processes (Chapter 51.

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STA TE LA US AND REG ULA TIONS 181 Federal Regulations Although the federal regulations on narcotic addiction maintenance treatment (21 CFR 291), originally included only methadone, those regulations were revised in 1989 to allow for the inclusion of other anti-addiction medications (Federal Register, 19891. In July 1993, concurrent with FDA's approval of the LAAM NDA, those treatment regulations were amended specifically to include LAAM (Federal Register, 19933. LAAM, like methadone, may be dispensed only by treatment programs approved by FDA, DEA, and designated state authorities (21 CFR 291.505~. The changes to the federal treatment regulations established a set of core standards (for such matters as patient evaluation and admission, medical and rehabilitative support services, and program sanctions) that could be applied to existing and future anti-addiction medications without requiring extensive additional rule-making. That framework preserved the opportunity to fine-tune such standards to account for the particulars of different medications (Federal Register, 1993~. In the case of LAAM, several specific restrictions on distribution were imposed to reflect the medication's characteristics as currently understood (Chapter 5~. For example, the regulation prohibits take-home dosing, primarily because of LAAM's relatively lengthy time to peak effect: an uninformed patient or new user might become impatient and take illicit drugs in the interim, resulting in a potentially fatal overdose when the LAAM effect peaks [21 CFR 291.505(k)~1~(iii); ORLAAM(~) package insert]. Also, the use of LAAM is prohibited in patients under 18 years of age, and strongly discouraged in pregnant women, in both cases because of an absence of relevant clinical data [21 CFR 291.505(d)(1)(iii)(B), (d)(iv); ORLAAM61) package insert]. State Regulations In contrast to the well-coordinated regulatory effort devoted to LAAM at the federal level, the lack of coordination at the state level has seriously hampered LAAM's availability. Some of the obstacles include formulary approval and reimbursement for treatment costs (Chapter 5~. The regulatory areas that pose the greatest problems, in addition to scheduling and rescheduling procedures, are the amendment of treatment regulations and the approval of treatment clinics. Sched ul ing/Resched ul ing As noted above, a controlled substance such as LAAM cannot be used in treatment in a state until it has been appropriately rescheduled (or scheduled) in

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182 DEVELOPMENT OF MEDICATIONS that state. Many variations exist from state to state, and the scheduling process can be cumbersome. For example, some states allow for automatic rescheduling based on federal rescheduling (Chapter 7), others follow a process of administra- tive rule-making, and many require new legislation which may take several years to enact. Additionally, some states have adopted the Uniform Controlled Substances Act, which includes a provision that directs the appropriate state officials to begin the administrative process to reschedule a controlled substance within 30 days of DEA rescheduling. However, many of the regulatory officials in those states, clearly with the authority to take action, wait for the legislature to reschedule by formal legislation. Thus, rescheduling may be a more cumbersome process than realized by simply reviewing states' laws. Finally, with regard to the rescheduling of LAAM to a Schedule II controlled substance, at least 30 states have taken action as of November 1994 (J. Thomas, BioDe- velopment Corporation, personal communication). Treatment Regulations Each state is responsible for amending its narcotic treatment regulations to permit treatment with a new medication, such as LAAM, and for monitoring narcotic treatment programs for compliance with state regulations. As of October 1994, only 24 states had completed the procedures to include LAAM in their narcotic treatment regulations not including California or New York (the states with 36% of the nation's narcotic treatment programs and about 45% of the opiate-dependent patient population~where the inclusion of LAAM requires legislative action that is not expected to be completed before 1995. Clinic Approval Each of the estimated 650 narcotic treatment programs (which can have more than one dispensing site; in 1992 FDA licensed 737 dispensing sites) must obtain state, FDA, and DEA approvals for their programs or clinics to dispense a new drug in the treatment of opiate addiction. In the 25 states where LAAM has been included in the treatment regulations, 89 of the 302 clinics have submitted applications to FDA for clinic approval in dispensing of LAAM. As of November 1994, 52 of the 89 clinics have received state and FDA approval. Nationwide, only 7 percent of all 737 dispensing sites have received final state, FDA, and DEA approvals to dispense LAAM.

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STATE LA US AND REGULATIONS 183 CONCLUSIONS Each of the 50 states and the District of Columbia has the authority to regulate the research, treatment, manufacture, sale, and distribution of controlled substances through the state controlled-substances laws and treatment regulations, a situation encouraged by the federal government to prevent misuse and diversion of controlled substances. However, the lack of a uniform approach and the lack of coordination between state and federal processes regarding the development of new anti-addiction medications results in regulatory hurdles and delays. As illustrated by LAAM, regulatory regimes that were created with the intention of controlling abuse of illicit substances can prove unwieldy and counterproductive when they are applied to a therapeutic product. Of course, future anti-addiction medications might not be Schedule I or II narcotics-or even controlled substances in which case many of the problems associated with LAAM would not occur. Inasmuch as anti-addiction medications are already perceived as a marginal business investment, the additional overlay of state laws and regulations can further deter companies from entering the field. That could be particularly true for smaller companies that have limited resources. Smaller companies may suffer an additional disadvantage if they have a limited number of products and cannot afford the time lag before realizing a return on their investment. To be sure, potential diversion is an issue for LAAM, as it is for methadone. But the regulatory system into which LAAM has been forced takes no account of the fact that the drug was developed, in part, precisely because of specific qualities that make it less of a target for diversion than methadone. The net result is that a drug that would save money for treatment clinics and ultimately for taxpayers, that would benefit opiate-addicted patients, and that would reduce the potential for narcotic treatment products ending up in the street trade, languishes practically unused more than a year after federal approval and rescheduling. RECOMMENDATIONS Organizational changes are clearly needed at the state level, with federal intervention, to prevent a repeat of the LAAM case and to restore the confidence of the pharmaceutical industry that new anti-addiction medications can be developed. The committee believes that steps should be taken by federal agencies within the existing system to reduce future state regulatory obstacles. The committee proposes a two-step set of actions, interim and long-term.

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184 DEVELOPMENT OF MEDICATIONS Interim Actions There are two interim steps federal agencies-the Office of National Drug Control Policy (ONDCP), NIDA, SAMHSA, FDA, and DEA should take under existing authorities to ameliorate the delays, complexity, and lack of uniformity at the state level. The committee recommends that federal agencies (ONDCP, NIDA, SAMHSA, FDA, and DEA) work more closely and actively with state regulatory authorities early in the drug development process to prepare the path for new anti-addiction medications. That recommendation can be implemented as follows: Identification of a regulatory point of contact in each state; Basic information could be given to the state contact early in the drug development process (preferably no later than the sub- mission of an NDA) about the medication, with emphasis on characteristics that would be of most interest to state regulatory authorities (diversion potential, target populations, or any special characteristics that would affect how the drug would be dispensed, such as dosing frequency). To the extent that any of the information is proprietary and confidential, the developer's permission for such disclosure would have to be obtained. As the medication moves closer to FDA approval, federal agencies could ensure that the necessary state regulatory processes begin immediately after approval, or, if state regulations permit, even before-such as upon the issuance of an approvable letter. . Federal agencies could work with the state contact, as the product moves through the state regulatory process, to correct any problems as they arise. The committee recommends that ONDCP, in cooperation with FDA, DEA, SAMHSA, and NIDA, take an active role in compiling relevant information about state regulatory processes for anti- addiction medications that are categorized as narcotics and educat- ing state regulators and pharmaceutical company representatives about the processes and their practical consequences. To implement that recommendation, the following steps may be taken: Conduct a comprehensive study of state laws and regula- tions pertinent to the development of anti-addiction medications that are controlled substances, and develop a step-by-step manual

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STATE LAWS AND REGULATIONS for pharmaceutical companies explaining the mechanisms involved in launching an anti-addiction medication. Establish and maintain on-line access to the comprehensive study, as well as to state regulatory information of a practical nature (for example, a directory of relevant state officials) to facili- tate pharmaceutical company access. Sponsor nationwide or regional educational meetings for state authorities and clinic administrators to disseminate infor- mation about potential anti-addiction medications. 185 Long-Term Actions Ultimately, close attention should be given to reforming the current patchwork of state regulations. The committee considered complete federal preemption of state controlled-substance laws and regulations insofar as those authorities affect the development of anti-addiction medications' but it concluded that such a proposal would go beyond what is strictly necessary and could be politically unrealistic. The committee does believe, however, that the initiative for reform must come from the federal government, and that it must involv some form of legislative charge. 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 con- trolled substances.2 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. Imposing specific deadlines for state regulatory action in re- sponse to FDA approval of a new anti-addiction medication that requires state action to be dispensed to patients. 20NDCP has previously drafted and put forth model state legislation on numerous topics, thus there is a precedent for model legislation on research and development of anti- addiction medications.

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186 DEVELOPMENT OF MEDICATIONS Developing flexible, alternative means of controlling the dis pensing of anti-addiction narcotic medications that would avoid the "methadone model" of individually approved treatment centers. Finally, the committee urges that Congress, in cooperation with the National Conference of Commissioners on Uniform State Laws, draft legislation requiring states to implement needed changes, rather third preempt outright the relevant state laws or regulations. The legislation could establish regulatory benchmarks (such as the length of time allowed after FDA approval for the state to talce legislative or other action; types of alternative dispensing controls). That legislation could be freestanding or as an amendment to NATA. Clearly, if the federal government wishes to remove regulatory obstacles to the development of ar~ti-addict~on medications, significant changes in current policies, laws, and regulations are necessary. REFERENCES Federal Register. 1989. Food and Drug Administration, National Institute on Drug Abuse, Methadone in Maintenance and Detoxification; Joint Revision of Conditions for Use (final rule). 54: 8954. Federal Register. 1993. Food and Drug Administration, Levo-Alpha-Acetylmethadol (LAAM) in Maintenance: Revision of Conditions for Use in the Treatment of Narcotic Addiction (LAAM Interim Rule). 58: 38,704. Massachusetts Bureau of Substance Abuse Services. No date given. Outpatient Methadone Services: Primary Service Elements and Staffing Requirements Attachment. NCJA (National Criminal Justice Association). 1991. Guide to State Controlled Substances Acts. Washington, DC: NCJA. Research Advisory Panel. 1993. 24th Annual Report of the Research Advisor Panel, State of California. San Francisco: Research Advisory Panel. SAMHSA (Substance Abuse and Mental Health Services Administration). 1992. Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies. Rockville, MD: SAMHSA.