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MDMA - FDA REPORT, 1985



RESPONSE:

The Food and Drug Administration has received inquiries about the drug MDMA (3,4-METHYLENEDIOXYMETHAMPHETAMINE) referred to in news media stories as an unregulated "DESIGNER DRUG."

The following may be used to answer inquiries.

MDMA is a psychotropic drug, street named "ADAM" and " ECSTASY, " popular among a small number of therapists and psychiatrists, although it has never been approved by FDA. The therapists claim that MDMA increases perceptions of self-insight and empathy. Recreational users claim that the drug relaxes inhibitions and enhances communications and sex. However, no INDs have been filed with FDA.

Chemically, MDMA is related to both the amphetamines and mescaline and especially to a potent stimulant known as MDA. Although it was developed in the 1970's, there was no enforcement activity involving MDMA manufacture or possession prior to last July. At that time, after a strong upsurge of MDMA street use, the Drug Enforcement Administration (DEA) proposed listing it as a "Schedule 1 Controlled Substance" -- the category for drugs with no medical use and a high abuse potential. In the Schedule 1 category (which includes heroin, LSD and MDA), clandestine production or sale of MDMA would be punishable by up to 15 years in prison and a $125,000 fine.

The DEA proposal was protested by some nurses, physicians and professors of pharmacology who wrote letters demanding a hearing. They challenged the proposed scheduling on the grounds that the drug has only a low or moderate abuse potential and has great therapeutic usefulness.

DEA announced May 31, 1985 it will not wait for hearings before acting because recent data indicate that the drug is being abused in 28 states. DEA is using a 1984 change in the Controlled Substances Act which allows emergency scheduling of drugs for one year. DEA's emergency ban will become effective July 1.

The emergency action is an interim measure to curb MDMA abuse until the longer administrative process can be completed. DEA has scheduled hearings June 10 and 11 in Los Angeles and July 10 and 11 in Kansas City. A third hearing will be scheduled later in Washington, DC. FDA will participate in the hearings to testify on the pharmacological aspects of the drug.