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 : 5158 Federal Register / VoL 53, No. 34 / Monday, February 22, 1988 / Rules end Regulations
 • of the medical prsct|tioners in the that "lack of accepted safety for _ae af reported major harm to individuals who
 United States, The drug MDIVIA has not the drug or other substance under bare used MDMA. this does not
 been approved for marketing in the medical supervisono" is not eonc_uslvely establish that MDMA is safe for use
 • United States by the Food and Drug demonstrated by lack of FDA approval under medical supervision. Scientists
 Administration° The chemist_, for marketing cfa drug or other and prudent physicians have concluded
 toxicology and pharmacology of MDMA substance ir_ tha United States, The fact that administration of MDMA to humans
 have not bean sufficiently studied in that a drug or other substance is not must not occur until further animal
 animals to provide a scientific basis for lawfully marketed in the United Staten studies are conducted to adequately
 experimentation or clinical use in may be a factor to be considered ia assess its potential toxicity in humans
 i humans. The published iReratu_ determining whether a substance lacks Based upon the lack of MDMA's
 contains no references tt_ the clinical use accepted safety for use under inedited established safety by animal and human
 of MDMA nor animal studies to fndlcate supervlsiono but it is not conclusive, testing, the leek of an FDA finding that
 such a clinical Uaeo Recognized texts, Before e drug may be tested ia MDMA is safe and may be safely
 reference books and pharmacopeia human_o the Food end Drug administered to humans, its
 contain no references to the therapeutic Administratlon, the agency charged by neurotoxicity in animals, and scientiflc
 i
 uee of MDMA. The two unpublished Congress with determining the safety and medical opinions that further testing
 : studies supporting the therapeutic use of and efficacy of drugs, requires _hat it be is necessary prior to human useo the
 MDMA which were presented• during the safe as demonstrated by animal testing. Administrator concludes that MDMA
 ..... hearings, de not contain any data which The first requirement in determining the lacks accepted safety for use under
 can be asssesed by scientific review to safety cf a substance is that the medical supervision.
 draw s conclusion that MDMA has a chemistry of the substance must be MDMA has no accepted medical use
 therapeutic use. indeed0 the known and reproducible. The next step tn treatment in the United States and
 psychiatrists who conducted the studies is to conduct animal toxicity studies to lacks accepted safety for use under
 admit _hat the information which they show that the substance wifi n_t medical supervision. The Administrator
 obtained was anecdotal, and that the produce irreversible harm to organs ,_t previously found that MDMA had a high
 studies were not scientifically proposed human doses. Limited clinical potential for abuse, a finding that was
 controlled° trials may then be initiated but they upheld on review by the United States
 Evidence in the record indicates that must be carefully controlled so that Court of Appeals for the First Circuit°
 at least four psychiatrists have adverse effects can be monitored an_:i The Administrator therefore concludes
 administerad MDMA in their practice to studies terminated if necessary, Very that MDMA should be placed into
 approximately 200 subiects. These httle of this information has been Schedule I of the Controlled Substances
 physicians were not conducting generated for MDMAo Safety in hum_ns Act,
 scientific studies with MDMA. they . _e evaluated as a risk/benefit ratio for a
 were administering the drug as if it was specific use, Any side effects found in List of Subiects in 22 CFR Pare 1]_
 an approved product which had been human testing are required to be made
 • scientifically tested. The evidence they known to the physician in labelir_ oJ_ Administrative practice and
 : presented wds merely anecdotal package inserts which accompany the procedure. Drug traffic control.-
 accounts of observations of patients, drug. MDMA is not available under _Narcotica, Prescription drugs.
 _ While many witnesses in this these conditions, Under the authority vested in the
 proceeding, including those presented The claims of safety by the Attorney General by section Z_(a) of
 by the agency, indicated that MDMA psychiatrists who have administered the Controlled Substances Act (22 U°S.Co
 may have a potential therapeutic use, MD_A are based on gross observations 8_1(e)} and delegated to the
 such a potential use is not sufficient to of the few subjects treated ss well as
 establish accepted medical use. A panel self-evaluation by the subiects. These Administrator of the Drug Enforcement
 : of international experts reached the anecdotal observations, while useful in Administration by regulations of the
 same conclusion, namely that there was the overall evaluation of a substances Department of Justice. 28 CFR 0._00(b}.
 insufficient evidence to indicate that the cannot eubst_tute for controlled stud_e_ the Administrator hereby orders that
 substanca had therapeutic usefulness, in animals end humans. There have Part 1308_ Title 21. Code of Federal
 The evidence in the record in this been studies ir_ animals _o show that Regulations, be amended es follows:
 proceeding does not support a finding MDMA produces long term serotonergic _AWr '_0_-_HEDUL_$ OF
 that MDMA has a "currently accepted nerve terrains| degenerat_Ono Such CONTrOL,LED SUBSTANCES
 medical _se in treatment in the United effects would not necassari_y be
 States." MDMA's lack of marketing observed immediately ih individuals I. The authority citation for Part 1308
 approval by the Food end Drug who hod taken the drug° The long term continues to reed as follows:
 Administration, coupled with the safety of MDMA ha_ not been Authadty: 21 U.S.C _I_, _ _7I(b).
 absence of reliable scientific data to established through reproductive or
 establish the therapeutic usefulness and carcinogenic studies, Since MDMA has 2o Section 1308.11 is amended by
 absence of widespread acceptance and not been shown to be effective for redesignating the existing paragraphs
 recognition in the medical community, treating a specific condition, it is (d}(7} through (d}(2_) as (d}[8} through
 ciear_), demonstrates that it has "no impossible to make e risk/benefit (d)(25) and adding a new paragraph
 currengy accepted medical use in analysis of the drug. Two psychiatrists (d}(7) as follows:
 treatment in the United States." who testified on behalf of the agency in
 The _econd of the three factors the proceedings indicated that they _ t$0_o_ _˘_ L
 required for placement of a substance in would not administer MDMA _o humans .....
 Schedule I is that there is "lack of until and unless further studies had been
 accepted safety for use of the drug or conducted t_ establish its safety and (d}" *"
 other substance under medicos lack of neuroto:zicity. (_) _°_
 me_hy|enedto_ymeth_mphets mine
 supervision." The United States Court of Although a few psychiatrists claim (MD_A) ......................................... ?_:
 Appeals for the First Circuit indicated that there has been relatively little , _ , , ,