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Regulating Methadone Treatment Programs:

The FDA Perspective

—Nicholas Reuter, Office of Health Affairs, Food and Drug Administration

The Food and Drug Administration (FDA) has very important responsibilities in regulating methadone treatment programs. FDA shares responsibility with the National Institute on Drug Abuse (NIDA) and with the Drug Enforcement Administration (DEA) for establishing and regulating the use of methadone in narcotic addiction treatment programs. FDA's involvement in this area stems from its responsibilities under the Federal Food, Drug, and Cosmetic Act to ensure that drugs are safe and effective.

Provisions of Narcotic Addict Treatment Act

In the early 1970s, FDA set forth a restricted distribution system to address concerns at that time about the relatively unstructured use of methadone to treat narcotic addiction. This distribution system was struck down in the U.S. Court of Appeals. Subsequently, Congress addressed these concerns when it passed the Narcotic Addict Treatment Act of 1974 (NATA), which modified the Controlled Substances Act.

This legislation gave DEA the responsibility for registering all practitioners who use methadone or other narcotic drugs in the treatment of narcotic addiction. This registration is required in addition to the registration that physicians must obtain in order to prescribe or dispense controlled substances. According to the NATA, the Department of Health and Human Services (DHHS) is required to publish treatment standards for the use of narcotic drugs when used to treat narcotic addiction.

FDA and NIDA have jointly promulgated these regulations, which have been modified over the years to reflect changes in various areas. In essence, these rules set forth the conditions under which narcotic drugs can be dispensed for the treatment of narcotic drug addiction and establish methadone as the only narcotic drug currently approved for such use. These regulations require that methadone maintenance treatment programs provide comprehensive services (e.g., medical, counseling, treatment planning, and vocational rehabilitation) in addition to dispensing methadone. FDA, with its field force of inspectors and investigators, is responsible for ensuring that all programs using methadone are in compliance with the FDA/NIDA treatment regulations for maintenance and detoxification.

Scope of methadone regulation

At present, this regulatory scheme is unique to methadone. FDA does not enforce rules that directly regulate the way an approved drug is distributed and dispensed in treatment. However, the scope and impact of the methadone regulatory effort is considerable. For example, almost 1,000 inpatient and outpatient methadone treatment programs are approved and currently operating with the concurrence of DEA and their State Authority in 46 States, including the District of Columbia, and 3 territories. This includes more than 700 narcotic maintenance treatment programs and about 250 hospital inpatient detoxification treatment programs approved by the FDA.

It is important to remember that the Federal methadone regulations set forth "minimum standards." There is frequent confusion about this, and Federal agencies are often contacted by programs with questions about stricter standards that are in fact being applied by the individual States. The legislation created to require these minimum standards sought to provide a legal framework that would allow the medical administration of narcotic drugs (such as methadone) to narcotic addicts to treat addiction. However, this legal framework has resulted in other benefits, such as gains in treatment approaches. In addition, recent studies indicate that methadone treatment is effective in limiting the transmission of HIV.

Future critical issues

The Federal Government's regulation of methadone treatment, and FDA's role in that regulation, is a very dynamic process. Two critical issues should be considered: compliance with the treatment standard regulations and the focus of the regulations themselves.

It is imperative to realize that FDA does not act independently in overseeing compliance with narcotic addiction treatment standards. In a number of areas, interagency cooperation and coordination are not only encouraged but are institutionalized. Such areas include the conducting of inspections, the evaluation of inspection results for followup actions, and the issuing of new regulatory initiatives. Vehicles for coordination are program guidance, memoranda of understanding (MOU), and interagency agreements (FDA has an MOU with both DEA and NIDA).

These coordination and cooperation procedures also apply to FDA/State interactions in regulating methadone treatment programs. Indeed, FDA regulations require State approval before a program can be approved by FDA. Additionally, a number of States carry out their own inspections.

Compliance with treatment standard regulations

FDA's methadone monitoring program applies the methadone regulations by conducting periodic compliance inspections. These inspections are conducted by investigators and inspectors, who may also inspect food establishments as well as drug, biologic, and medical-device manufacturing establishments.

FDA has developed specific procedures and policies for methadone program inspection. The FDA inspector usually selects a sample of a program's records to review. Once the inspection is complete, FDA reviews guidances, memoranda of understanding, and the regulations themselves to determine what, if any, followup activity is appropriate. Any followup actions are based on a variety of factors, including the severity of noncompliance and longstanding patterns of noncompliance.

In recent years, FDA has increased the number of compliance inspections carried out for methadone treatment programs. Concomitantly, the number of regulatory actions has increased. It appears that a number of methadone treatment programs do not fully conform with the regulations, nor do they respond to Federal efforts to correct deficiencies. Indeed, FDA and DEA have recently initiated efforts to close some programs which have long-standing histories of continual noncompliance with regulations.

Some representatives within the Federal Government, including some members of Congress, believe that there are programs which operate in almost total defiance of these FDA regulations. It is important to realize that this attitude is unacceptable for many reasons. FDA's new Commissioner, Dr. David Kessler, has stressed enforcement and integrity as FDA priority areas. In addition, some in Congress have stressed that methadone is acceptable only when administered in accordance with treatment regulations. Moreover, it is not sensible to assign resources to revise and improve regulations if these regulations are not followed.

Potential revisions to focus of the regulations

While the regulations foster quality in programs, there are a number of intangibles—such as compassion, communication, concern, caring, and other elements of a good program—that cannot be established by regulation. Furthermore, important issues such as funding, other resources, and neighborhood support are critical, and yet these issues are not part of FDA's regulatory approach.

Although FDA's role in improving the quality and effectiveness of methadone treatment programs is limited by regulatory, statutory, and resource restraints, the agency acknowledges and encourages measures on the part of others that can contribute to the quality and effectiveness of programs. Results from research funded by NIDA indicate that there are consistent techniques employed by "successful" methadone programs. FDA and NIDA will be evaluating whether regulations can be changed to be more outcome-oriented. Regardless of whether regulations are process- or outcome-oriented, programs will have to comply.

We at FDA hope this ongoing review and refinement activity will lead to the ultimate goal—reducing diversion and other problems—while further improving the quality of methadone treatment programs.

Last Updated May 17, 2001