Letter to the Editor

GHB Legislative Update

Patti Engel
Vice President of Marketing and Sales
Orphan Medical, Inc.
13911 Ridgedale Drive
Suite 250
Minnetonka, MN 55305
Voice: 952-513-6999
FAX: 952-541-9209
Email: PEngel@Orphan.com

Int J Med Toxicol 2000; 3(5): 33


Earlier this year, an editorial in this journal reviewed the efforts by the federal government to curb the growing abuse of gamma hydroxybutyrate (GHB)(1). As noted in the editorial, this increased enforcement prompted former users of GHB to begin using various GHB analogs, such as gamma butyrolactone and 1,4-butanediol. Since that time, this legislation has been amended and the regulation of GHB and its analogs has become much more tightly controlled.

On February 13, 2000, President Clinton signed into law the Hilary J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000, amending the Controlled Substances Act and making GHB a Schedule I agent (2). This legislation makes manufacturing, distribution and possession of GHB illegal. It also specifically bans the manufacturing, distribution and possession of gamma butyrolactone and 1,4-butanediol when they are intended for human consumption.

Fortunately, these new regulations also allow GHB to be controlled as a Schedule III drug if it is being used under an FDA-approved New Drug Application. GHB, known by its official generic name as sodium oxybate, is currently undergoing clinical trial by sleep disorder clinicians. They and the victims of narcolepsy are grateful that this legislative language acknowledges the medicinal value of sodium oxybate. When approved, sodium oxybate will be marketed under the brand name Xyrem®.

On a local level, each state has the option of adopting these Federal scheduling guidelines or imposing scheduling which is more restrictive than the Federal recommendations. To date, a "split" schedule (Schedule I/III), consistent with Federal actions, has been adopted by approximately one half of the country. This has this been accomplished without legislative intervention in all but a few states. In other states, discussions with various parties (boards of health, pharmacy boards, state legislators and law enforcement) are continuing and many will likely adopt the Federal scheduling guidelines upon FDA approval of sodium oxybate, in early 2001. In addition, exemptions exist in most states for clinical research being conducted on drugs with Schedule I status. Thus, most states in which this dual schedule has not been adopted are still allowing clinical research on sodium oxybate to proceed.

The authorization for this research has been of great clinical value, and submission of a New Drug Application to the Food and Drug Administration will occur in late 2000. Plans are currently underway to ensure that diversion of sodium oxybate for illicit use is prevented through the development of a closed loop distribution systems. Using this system, physicians will prescribe sodium oxybate which will be dispensed nationally from a single pharmacy. Scrutiny of physician prescribing will prevent/identify the diversion of sodium oxybate for inappropriate use. A patient signature will be required for delivery, preventing possible diversion while monitoring patient compliance. Patients will be educated that under Federal law, illicit use of sodium oxybate will be treated with the same harsh penalties as the illicit use of the Schedule I GHB.

In addition to promoting the dual schedule for GHB, sodium oxybate advocates are attempting to work with each state to alter their "analogue language" which would broaden their legal definition to include compounds such as 1,4,butanediol and tetrahydrofuran. This has not been possible at the federal level because, unlike GHB, these analogs have legitimate industrial use. The ability to introduce language addressing illicit manufacture, possession and distribution will enable law enforcement the opportunity to prosecute sexual assault and drug sales and possession cases when the illegal use of these agents is at issue. To date, only California, Nebraska, South Carolina and Pennsylvania have analogue statutes that reflect Federal law and can therefore control the illicit use of GHB analogues. Hopefully these efforts will further increase awareness for the need of this legislation.

References

  1. Nelson L: Butanediol and ethanol: a reverse Mickey Finn? Internet Journal of Medical Toxicology 3; 2, 2000.
  2. Federal Register 65; 13235-13238, 2000.


Int J Med Toxicol 2000; 3(5): 33

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