Question 4: How have U.S. regulations about treatment for heroin addiction evolved?

Answer: U.S. regulations about treatment for heroin addiction evolved through three time periods:

• 1914-1972
• 1972-2000
• 2000-Present

U.S. regulations about treatment for heroin addiction have evolved from strict prohibition of medical prescription of heroin to treat addiction, which began in 1914 and continued into the 1960s. Initial pilot studies testing methadone maintenance treatment for heroin addiction began in 1964, and methadone maintenance treatment was formally approved in 1972. Scientific advances prompted major reviews of Federal regulations by the Institute of Medicine in 1995 (Substance Abuse and Mental Health Services Administration, 2000b) made significant changes in U.S. regulations about treatment for heroin addiction, reducing Federal regulations and paving the way for new pharmacotherapies to treat heroin addiction.

1914-1972
Although heroin became a controlled substance under the Harrison Act of 1914, the law did not expressly prohibit the medical prescription of heroin to treat addiction. The U.S. Government concluded that the Harrison Act intended to prohibit such medical uses of controlled substances, prosecuting individual doctors who prescribed the drugs. In 1919, the U.S. Supreme Court upheld the Government’s position in Webb v. United States. In response, about 40 localities opened municipal narcotic clinics to treat addiction using a variety of methods, including medical prescription of narcotics, but by the mid-1920s, these clinics had all been closed by the Federal Government (Joseph, Stancliff, and Langrod, 2000).

1972-2000
Methadone maintenance treatment for heroin addiction was first approved by the U.S. Food and Drug Administration in 1972, subject to three levels of Federal regulation:

• Food and Drug Administration rules that pertained to all prescription drugs
• Drug Enforcement Administration rules that governed all controlled substances
• Unique Department of Health and Human Services rules limiting methadone maintenance treatment to strictly controlled opioid treatment programs, which also were subject to additional State or local rules

2000-Present 
Substance Abuse and Mental Health Services Administration, 2000a), was approved for office-based dispensing by the Food and Drug Administration in 2002.

References

Courtwright D. A century of American narcotic policy. In: Institute of Medicine. Treating Drug Problems: Volume 2. Washington, DC: IOM, 1992, pp. 1-62. Available online at: books.nap.edu/openbook.php?isbn=0309043964. [Accessed March 23, 2006.]

Hentoff N. The treatment of patients - I. The New Yorker 1965;June 26:32-77.

Joseph H, Stancliff S, Langrod J. Methadone maintenance treatment (MMT): a review of historical and clinical issues. The Mount Sinai Journal of Medicine 2000;67(5 & 6):347-64. Available online at: http://mountsinai.site-ym.com/?page=Journal_of_Medicine/67/6756.shtml. [Accessed March 23, 2006.]

Marion IJ. Methadone treatment at forty. NIDA Science & Practice Perspectives 2005;3(1):25-31. Available online at: http://archives.drugabuse.gov/perspectives/vol3no1.html. [Accessed March 23, 2006.]

National Institutes of Health. Effective Medical Treatment of Opiate Addiction: Consensus Development Conference Statement. Bethesda, MD: NIH, 1998. Available online at: http://consensus.nih.gov/1997/1998TreatOpiateAddiction108html.htm. [Accessed March 22, 2006.]

Rettig R, Yarmolinsky A (eds.). Federal Regulation of Methadone Treatment. Washington, DC: Institute of Medicine, 1995, pp. 1-16. Available online at: books.nap.edu/catalog.php?record_id=4899. [Accessed March 22, 2006.]

Substance Abuse and Mental Health Services Administration. About Buprenorphine Therapy. Rockville, MD: SAMHSA, 2000a. Available online at: http://buprenorphine.samhsa.gov/about.html. [Accessed March 23, 2006.]

Substance Abuse and Mental Health Services Administration. Drug Addiction Treatment Act of 2000. Rockville, MD: SAMHSA, 2000b. Available online at: http://buprenorphine.samhsa.gov/data.html. [Accessed March 23, 2006.]