Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies
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| 1966 |
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This legislation stemmed from the perspective that narcotic addiction is an illness for which treatment services are necessary. Here, treatment included medical, educational, social, psychological, vocational, and rehabilitation services provided in an institution or through supervised aftercare. The law provided for the civil commitment of addicts not charged with a Federal offense to Public Health Service hospitals for treatment, if no comparable care was available in another appropriate facility. The Act authorized Federal courts to commit to the Public Health Service eligible narcotic addicts who were charged with a Federal offense and who desired treatment, in lieu of prosecution for the criminal charge. It allowed the commitment of addicts who had been convicted of a crime to receive treatment in a Bureau of Prisons facility.
Public Law 89-793 made grant funds available to States for demonstration programs for treating narcotic addicts, the development of training and educational materials about treating narcotic addiction, the development of training programs, and surveys evaluating the adequacy of treatment programs. The Law authorized the Surgeon General to enter into jointly financed agreements with States to develop, construct, and staff addiction treatment programs, including aftercare programs.
| 1968- 1970 |
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In 1968, responding to inconsistencies and fragmentation of laws related to drug abuse and control, President Johnson's administration developed a plan to reorganize the responsibilities of various agencies involved in control of dangerous narcotics and other drugs. Under this plan, functions <R>of the Department of Health and Human Services (DHHS) (formerly the Department of Health, Education and Welfare) and the Treasury Department, with the exception of those involving customs, were merged and transferred to the Department of Justice as the Bureau of Narcotics and Dangerous Drugs (now the Drug Enforcement Administration (DEA)). In 1969 recommendations were forwarded to Congress to reorganize existing laws under one statute that reflected the reorganization plan.
A variety of drug abuse treatment and control bills were introduced in the House of Representatives and the Senate. All these proposals were attempts to create a more comprehensive drug control and addiction treatment law.
| 1970 |
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This law created a comprehensive statute for drug abuse issues by combining the intent of sections of existing laws and expanding on issues not previously addressed. It provided for increased research into drug abuse and drug dependence and their prevention; provided for treatment and rehabilitation of drug abusers and drug dependent persons; and strengthened existing law enforcement authority and criminal penalties involving illegal trafficking in controlled substances. The law established requirements for a special registration for physicians treating narcotic addiction. In addition, it established five schedules of controlled substances according to their potential for abuse. The law authorized the Attorney General (Department of Justice) to handle the control and diversion aspects of prescribing narcotics, and the Secretary of the Department of Health, Education and Welfare to handle the safety, effectiveness, and quality aspects.
One objective of this law was to improve the quality of treatment of narcotic addiction by encouraging private physicians to treat narcotic addicts. By clarifying the policy for acceptable standards of care for treating narcotic addicts, the law was intended to dispel the fears of prosecution for providing narcotic drugs that had previously kept physicians from treating addicted patients.
| 1972 |
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The Food and Drug Administration (FDA), in consultation with the White House Special Action Office for Drug Abuse Prevention (SAODAP), the National Institute of Mental Health (NIMH), and the Department of Justice published regulations that placed methadone in a legal drug class between an investigational drug and an approved drug. The regulations allowed methadone to be used as an analgesic and as a treatment for narcotic addiction through a closed distribution system of approved pharmacies and methadone treatment programs. The regulations contained procedures for approval of treatment programs, mandated standards, and procedures for revoking approval for failure to comply with standards. The regulations required each State's appropriate official to designate a State Authority (SA) to be responsible for treatment of narcotic addiction with a narcotic drug within the State or territory.
| 1972 |
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The APhA challenged FDA regulations regarding the restriction of methadone distribution through approved pharmacies. This resulted in an amendment to FDA regulations that allowed methadone to be dispensed upon prescription through pharmacies for analgesic purposes only, but continued to restrict distribution for narcotic addiction treatment through approved methadone programs.
| 1974 |
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This law amended the Comprehensive Drug Abuse Prevention and Control Act of 1970. It recognized the use of a narcotic drug in the treatment of narcotic addiction as critical and, for the first time in Federal law, defined "maintenance treatment." In an effort to promote closer monitoring of programs using narcotics for maintenance treatment, the law required separate registration by DEA of medical practitioners who dispense narcotic drugs in the treatment of narcotic addiction. Prior to registration by DEA, DHHS must determine that the practitioner is qualified according to established standards of treatment. The law promoted increased coordination between DHHS and DEA.
Through P.L. 93-282, enacted in 1974, the National Institute on Drug Abuse (NIDA) was established as an institute independent from NIMH. The authority delegated by DHHS for the treatment of narcotic addiction was split between NIDA and FDA. NIDA became responsible for determining appropriate standards of treatment for medical, scientific, and public health aspects of drug abuse. FDA was delegated the authority to determine the safety and effectiveness of drugs and approve new drugs to be used in narcotic addiction treatment.
| 1975- 1989 |
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Since 1975, the Commissioner of FDA and the Director of NIDA have worked to jointly publish methadone standards required by the Narcotic Addict Treatment Act. The standards were revised several times and revisions were published in the March 2, 1989 Federal Register. These regulations establish methadone as the only narcotic drug currently approved for narcotic addiction treatment, require methadone maintenance treatment programs to provide comprehensive services in addition to dispensing methadone, and establish a minimum standard of care that all programs must maintain.
| 1989- 1990 |
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In the Federal Register of March 2, 1989, FDA and NIDA jointly published a proposed regulation to revise the conditions for the use of methadone in narcotic treatment programs. This initiative was developed in response to the human immunodeficiency virus (HIV) epidemic in the injecting drug user population and evidence that methadone treatment is an effective method of limiting the transmission of HIV among this population. At the same time, many treatment programs were reporting waiting lists for treatment. The proposal allowed narcotic treatment programs to provide interim maintenance treatment to patients awaiting placement in comprehensive maintenance treatment and required such programs to provide counseling on avoidance and transmission of HIV disease. The proposal was intended to allow narcotic treatment programs greater flexibility in admitting narcotic addicts into treatment.
FDA and NIDA received over 80 comments on the proposed interim maintenance provisions, which revealed large differences of opinion both on the desirability of adopting the interim maintenance provisions and on a number of related issues. Several comments stressed the potential importance of interim maintenance in checking the spread of AIDS while others contended that the resources and funding that participating methadone treatment programs would have to provide to offer the proposed interim maintenance treatment would be at the expense of the current comprehensive maintenance treatment and would therefore diminish the role of comprehensive narcotic treatment programs in reducing injecting drug use.
Because of these differing views and in light of comments urging that an expert meeting be convened to address the complex issues posed by the proposal, the agencies concluded that it was necessary to solicit additional information before making a final decision. At a public hearing held February 28, 1990, 28 individuals representing 20 organizations provided testimony before representatives from FDA, NIDA, and other Public Health Service organizations.
| 1992- 1993 |
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Effective October 1, 1992, section 501 of this act established the Substance Abuse and Mental Health Services Administration (SAMHSA) within the Public Health Service, consisting of a Center for Substance Abuse Treatment (CSAT), a Center for Substance Abuse Prevention (CSAP), and a Center for Mental Health Services (CMHS). SAMHSA was granted authority to coordinate Federal policy to provide substance abuse treatment services using anti-addiction medications including methadone. Among the responsibilities of CSAT, formerly the Office for Treatment Improvement, are administering the Substance Abuse Prevention and Treatment (SAPT) Block Grant, funding demonstration projects, conducting State and program evaluations, and providing technical assistance to States and block grant subrecipients.
The Act also authorized the Secretary of Health and Human Services, after consultation with the National Commission on AIDS, to issue regulations for the conditions under which a narcotic treatment program can provide interim maintenance treatment. On January 6, 1993, the Commissioner of FDA and the Acting Administrator of SAMHSA jointly issued regulations pertaining to interim maintenance. The regulations also require all narcotic treatment programs to provide counseling regarding exposure to and transmission of HIV disease for each patient admitted or readmitted to maintenance or detoxification treatment.
*This summary of legislation reviews acts, laws, and proposals that are related to treatment issues or the roles of Federal agencies involved in the approval and monitoring processes. Many other laws were enacted between 1914 and 1970 that more specifically relate to the control of dangerous drugs.
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