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GLUTETHIMIDE MOVE TO SCHEDULE II WITH ZERO PRODUCTION QUOTA

Executive Summary

GLUTETHIMIDE MOVE TO SCHEDULE II WITH ZERO PRODUCTION QUOTA for 1991 was recommended by FDA's Drug Abuse Advisory Committee at its June 4 meeting. The Drug Enforcement Agency had asked FDA to recommend strict restrictions for the 1960s- era oral hypnotic sedative, currently a Schedule III controlled substance. Glutethimide is manufactured by a number of generic drug companies but was recently discontinued by Rorer, which had marketed the agent under the tradename Doriden. * DEA representatives at the meeting indicated that the rescheduling and suggested production quota for next year will appear as a proposal in an upcoming Federal Register. The move by DEA and FDA to reschedule glutethimide was based on: (1) evidence from law enforcement and medical sources of the compound's abuse, including emergency room and medical examiner data on overdoses and deaths; and (2) the fact that no subpopulation could be identified by FDA for whom restriction of access to the drug would constitute a medical problem. Generic firms holding ANDAs for glutethimide include Halsey, Chelsea, Cord, Danbury, and Lannett of Philadelphia. Danbury has not manufactured glutethimide since 1985. NDA-holder Rorer has informed FDA that it discontinued production and destroyed its remaining supplies as of May 22, 1990. Halsey was the only manufacturer to send a representative to the committee meeting. Halsey Director of Regulatory Affairs Fred Shainfield, PhD, who arrived after the committee had already passed its motion, told the panel that his company would be willing to manufacture the drug as a Schedule II product. Halsey may petition for an increase in the glutethimide production quota if it is set at zero, but will not "kick and scream," Shainfield said. The firm currently manufactures only 1 mil. tablets of the compound annually. In answer to a committee question, Shainfield said he knew of no specific patient population for whom the drug provided an advantage over other available therapies. The advisory panel initially discussed whether to make glutethimide a Schedule I drug, allowing no production except for research. However, John Harter, MD, head of FDA's Pilot Drug Evaluation staff, pointed out to the committee that a move to Schedule I requires evidence that a drug cannot be used safely even for labeled use. Schedule II rules, however, while not removing marketing approval outright, allow FDA to recommend annual production quotas for a controlled drug to DEA. By setting those limits at zero, the drug agencies hope to effectively remove the drug from the market, while leaving manufacturers the right to petition to raise the quota if a legitimate medical demand emerges. Glutethimide, once a popular therapy for insomnia, has been declining in legitimate medical use for years, FDAer Carlene Baum, PhD, Division of Epidemiology and Surveillance, told the committee. The drug has sunk from 6 mil. U.S. prescriptions a year in 1970 to 164,000 in 1988 and now makes up less than 1% of the U.S. market for hypnotic sedatives, Baum reported. However, glutethimide has a high abuse rate relative to its number of prescriptions, Baum pointed out. Glutethimide averages 2,800 abuse reports per million prescriptions, compared to 115-215 abuse mentions per million for drugs in the benzodiazepine class. An FDA medical literature search found no reports of glutethimide advantages over other more current sedative therapies, such as the benzodiazepines, according to a presentation by Michael Klein, PhD, Pilot Drug Evaluation staff. He also reported that the DEA seized 23,000 doses of diverted glutethimide between 1986 and 1988. * The Drug Abuse Advisory Committee also resolved unanimously that "it would be inappropriate" to schedule anabolic steroids under the Controlled Substances Act." Several bills currently before Congress propose to regulate steroids under the CSA due to sports industry abuses. FDA asked the committee if it wished to comment on the issue. Summing up the committee's discussion, chairman Theodore Cicero, PhD, Washington University of St. Louis, said steroids "have not been shown to possess psychoactive effects comparable to substances currently scheduled" and "do not satisfy the criteria of the Controlled Substances Act." The committee also suggested that Congress fund additional research of steroid adverse effects.

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