Richard A. Rettig – författare

For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone''s effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction.

Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.

Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice.

Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency''s management of the system; and increasing the accountability of the system to the public.

In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA''s management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

Since 1972, many victims of endstage renal disease (ESRD) have received treatment under a unique Medicare entitlement. This book presents a comprehensive analysis of the federal ESRD program: who uses it, how well it functions, and what improvements are needed.

The book includes recommendations on patient eligibility, reimbursement, quality assessment, medical ethics, and research needs.

Kidney Failure and the Federal Government offers a wealth of information on these and other topics:

This book will have a major impact on the future of the ESRD program and will be of interest to health policymakers, nephrologists and other individual providers, treatment site administrators, and researchers.

For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone''s effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction.

Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.