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 3_ Fsdeml Register / VoL Sl, No. 198 / Tuesday° Octobsr _40 _19_ / Rules and Regulations
 Herapeutical|y motivated sort|n8 for _awfuily marketed _ the United States his responsibility to pr_tsct the
 curiosity or rscreatio_ pursuant to _e Federal Foo_ Drug and American public from the abuse and
 86° Dr. Joseph _o Downing, a p_ac_ci_g Cosmetic Act of 1@38 (FDCA), 21 U.$oC,. misuse of dangerous drugs, declare
 ....... psychiatrist in San Francisco, CCalifurzda_ 355° The FDCA establlshea procedures legitimate a substance which has not
 conducted a pilot study in _984 into the regardin8 approval of drugs for been found safe and effective under ths
 effects in healthy humans of a single marketizt_ _ ths United States. a_td an procedures required by the FDCA. Ha
 exposure to MDMA. The 2_ subjects in exemptlsn for Luvestigational use of cannot find that a drug, which is not
 Dr. Downing's MDMA study had all approved drugs prior to rnarketln_, avai|able through commercial, legitima_
 used MDMA previously. One had u_d These procedures requipe that FDA must charnels to the medical community_ has
 MDMA tS times, one 10 timer and un_ approve a new drug as bein8 safe and aa "accepted medics| use in treatment
 only once. The mean frequency of use of effective bsfom it may be introduced i_ the United States°" The fact that a
 the 21 sabjects was once every _ into _te_tats _erce in the United handful of physicians ape of the optnio_
 ...... months. Stat_o that a substance may have therapeutic
 87. D_. L_st_ Grinspoon reports that If a substance is not marketed _n value is not an acceptable alter_atlve, t_
 MDMA is being taken by a 8rowLu_ _ter_tate commerce _n the United the thorough clinical and ppecli_ica|
 number of people, particularly students States° _t is not manufactu_d by ':he evaluation which precedes the approw_
 and young professionals _ a casual and pharmaceutic,el rnanufact,_tr_rs who ape of an _A_
 recreational manner, licensed by the jFDA to produce the vast
 _o Dro George Greer, a prectlcln_ array of medicatioz_s currently avai]able Another finding required to b_ _ad+
 psychiatrist in Santa Fe, New Mexico. _ this country_ it is not distributed by by the Administrator for placement o_
 has used _DMA as an adiunct to phar_aceutic._ wholesalers liter _d to substance in Schedule I is that "there i_
 psychotherapy in clinical work. He se|] ph_rn_cceutical_o it is not stocked in a _ac_ of accepted safety for use of the
 reported that one of his subjects, after retail pharmacies, hospitals and other drug or other substance under medical
 _akiog the unusually high do_agn of 358 medical facilities which dai|y dispense supervision/' The same rationale
 rag. of MDMA_ Peported visual drugs to patients; and it carrot bs discussed with regard to "accepted
 hat]we|nations, J_lu_ons. heari_ prescribed by the hundreds of thousands medical use" applies to "accepted safeV
 impairment, brief memory loss and of physicians and oiler prsctitie_ters for use _. o under medical supervision. °_
 distortion in depth perception, who ar_ authorized by their licenses and MDMA has not been approved for
 89. Between 1977 and 19_, the Dru_ registrations to prescribe market|riB in the United States by the
 Abuss Warning Network (DAWI_) pharmaceuticals° including controlled Food and Drug Administration. MDMA
 reported eight emergency room episodes substances° _n the course of their has not been approved for
 associated with the use of NK)MA. professlona_ practices. Such a substance investlgational use by the Food and
 _. MDMA is reporled to have been cannot be said t_ have a "currently Drug Administration. No studies have
 associated with two overdose deaths, accepted _edical use in t_otme_t i_ the bean submitted to the Food and Drug
 One death occurred in Seattle, United States." (Emphasis _dded) Administration which would
 Washington h_ _979, and one in Santa The complex system of approval for demonstrate the safety of MDMA with
 Monica, California. marketing and cnnditisns for use of non- reliable scientific datao There is _o ba_
 •1o The Assistant Secretary of Health. approved drugs for investigstlon,al upon which to conclude that iNfDIVL_ he_
 Department of Health and Human purposes is designed to pr_tsc_ the "accepted safety for use.., under
 Services, in his scientific s.ud medlcal health of the humans to wh_yz_ tee drug medical supervision."
 evaluation of MDIvIA. concluded that is to be _iven. A drug must be sb _wn to _nstead of relying on scientific dater o_
 MDMA has a high potential for abus_o be safe sod effective before any the opinion off the Food and Drug
 92° Therefore, the Administrator find_ manufacturer can market it in this Administration, the Administrative L_
 that MDMA has a high potential for country. Approval of a substance makes _udge chose to rely upon the "world of
 abuse, it "acceptable" and available fo_ health care practitioners" to determine
 D_us_ medical use. Aoy other meaning of "accepted safety for use." Hs chose t_
 "currently accepted medicM use in disregard sclentific_ controlled studlss
 The phrase "currently accepted h©eatme_t in the United States"° _ther conducted by scientific researchers
 medical use in treatment in the United than approval for marketing by the Food which havs shown MDMA to be
 States" is found |n _I U.SoC 81_b). It is end Drug Admlnistrstlor_ would make neuroto_c when administered to ret_,
 one of the three findings r_quL_d for the NDA process a sham and wouJd sod instead substituted the anecdotal
 placement of e substance into one of Lhe require pure conjecture on the part of
 judgments of a handful of physicians
 five Schedules o_ the Controlled the Secretary and the Administrator in who observed the behavior of hurna_
 Substances Act. Whereas placement of determinln 8 if a substance had s n animals under the influence of N_)_,U_..
 a drug or other substance into Schedules "accepted medicos usa+" This
 lJ through V requires a finding that the interpretation is also conslate_t with A drug's safety for use in huma_,
 substance has a currently accepted that of the Uniform Controlled both at the _nvestlgatlonel stags and s_
 medical usa in treatment in the United Substances Act, which has been _ the marketing approval stage, can o_y
 States, placan_en_ of a substencs Int_ adopted by almost all of the 58 states, be established through contro_led
 Schedule I requires a finding that the The Adminlstrative Law _ud_0 in scientific studies which are submitted _,:
 substance "has no _urren_ly accepted recommending that the Administrator and evaluated by the FDA. These
 medics| use in treatment in the United find that _L)b/_A has az_ accepted determinations are given 8peat weigL_
 States. +' 21 U.S.C. 812(b)(I)_l. The medics| use in treatment, urged that the by the Administrator in evaluating
 Con_rol|sd Substances Act doss not Administrator look at ++what is m_ctusliy scientific and medics] matter_o
 define this term+ _In8 on within _e health cars For placement of a substance in
 The Administrator concludes that the community .° in order to make this Schedule L the Administrator is als_
 term "currently accepted medical use _ determination. The AdmL_strstor required to find that "the drug or ot_ +
 treatment in the United States" means cannot accept this recommendation+ The substance has a high potentiM for
 that the drag or other substance is Adr_nistrator carrot, consistent with abuse."