|
Items in cart [1] |
Questions? Call 888-624-8373 |
| Copyright © 2009. National Academy of Sciences. All rights reserved. Terms of Use and Privacy Statement |
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 173
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
OCR for page 174
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
OCR for page 175
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
OCR for page 176
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~.
OCR for page 177
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
OCR for page 178
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
OCR for page 179
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
OCR for page 180
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.
OCR for page 181
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
OCR for page 182
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.
OCR for page 183
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.
OCR for page 184
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
OCR for page 185
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.
OCR for page 186
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.
Representative terms from entire chapter:
treatment programs
