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 F_c:lersl Re_ster /_'QO|o $I_ Noo 198"_ _T'ues_ay_ October _Ao_gB_ /Rules ann Regu|at|ons
 investigational new drug (_D) tl_ze wt|_ b_ no unreasonable hazard in MDMA wee not a grandfathered drug
 processes. The data in the NDA mua_ initiating studies in humans; a detailed and that it had not been approved for
 include toxicity studies, carcinogenic research protocol of the proposed over-theocounter use°
 studies in animals, reproductive studies clinical Lnvestigation, Information 8. On funs _ 1984. the Acting
 ..... in animals, side effects in humans+ and regardir_ the training and experler_ces Assistant Secretary for Health sent a
 sufficient results from controlled studies of the investigators; and an agreement to letter ts Lhe Administrator of DF,A
 to show that the drug is safe and notify the FDA if any adverse effects which stated that a scientific and
 effective in humans for the therapeutic arise durirt$ animal or human tests, medical evaluation of MDMA had been
 purpose advanced by the sponsor. New @. On [one 29, 198_ the Food and Drug completed. He further recommended
 drug applications have been required Ad_alnistration (FDA} published in the that MDMA be placed in Schedule I of
 prior to marketing since _193_. Federal Re, star "Proposed the CSAo Attached to the letter was en
 i 2o Section 505 of the Federal Food Recomraendatlons to the Dro_ "Evaluation of the DEA
 Drug and Cosmetic Act (2'I U.S.C. 3._) FJ_foroement Administration Regarding Recommendation to Control NfDMA i_
 outlines the new drug application the Scheduling Status of Marlhusna end Schedule I of the CSA/_ In this
 process. The _tatute provides at section its Components and Notice of Publ_c evaluation, the Acting Assistant
 S0S(a) that. "No person sha1_ introduce Hea_ng" (47 FR 2,8_4_I) in which the Sccre_ary for Health stated that ha
 or deliver for introduction into interstate Con_a_is_oner of Food and Dru_s sta_e_ concurred with DEA's _commendat|oB
 commerce any new drug. teresa an FDA interprets the _arm "accepted m_dt_ of Schedule I for MDI_J_.. The eva|ust_o_
 approval of an application filed usa" to mean i_wfui_y m_rkatad _der l he included a list of the findings required t_
 pursuant to subsection (b) of this _ection Federal Food. Drugs sad Cosmetic Act° Zl be made for Schedule I substances.
 is effective _th respect to _ch drug. '° U.S.C. _. et seq.... A drug may b_ which included the finding that the drug
 The statute further provides that a marketed _swfully under the Federal _s_ has no currently accepted medical use
 person filing an app|i_tion _or a new Drug_ end Cosmetic Act altar app_val ,_f a treatment in the United States. The
 drug must include "full reports of new dug _pp_|cation (_DAI for that _n_g. eval_atlon of the Acting Assistan'_
 investigations which have been made to Them a_. _heo_t_ccatiy o_her ways _ which
 show whether such drug is effective in _ drug couid be marketed ]_a|_y. The drug Secretary for Health stated that he
 could _¢t_sfy either the requirements fo_ concurred wiLh this finding°
 usa." [Section SOS(b)). exemption f_om the de_nitton o_ "new cL_s" @. The phrase "currently accepted :
 3. Section 505(i) of the Federal Food, in 21 U.S.C. 3_'I(p) o_ the requir_raents Io_ a medical use in treatment in the United
 Drug and Cosmetic Act allows the °°srandfathe_ clause" f_m the new dru_ States" as used in 21 UoS.Co 8_2_ means _
 Secretary o_ the Department of Health approval provision. (47 F_ _s_o) that the Federal Food and Dr,.t_
 and Human Services to exempt from the The Commissioner of FDA coatir_sed Administration has determined _at •
 application of ther_quiremente of at page _ISI hy saying: drug or other substance can be _awftdb/
 approval of an NDA prior to marketing
 °'drugs intended solely for The mechanism set up by C¢_a_'_sss tot marketed in the United States°
 investigations| use by experts quaI_fied _wfu_ marketing of a new dry r_qui._ _0. S_nc_ it has been determined that
 submission of an NDA to FDA and F_A MDI_La_, may not be lawfully marketed _
 by scientific training and experience to app_ovat of that application before the United States, the Administrator
 i investigate the safety and effectiveness marketing. _efor_ FDA can approve an NB_ .finds that NfDMA has no currently
 .... ; of drugs." The section goes further t_ however, the drug sponsor must _ubmit data accepted medical use in treaL_ae_t in the
 delineate certain _quiremants which from sn e_tens_ve battery of e_pe_mee_at _nited States.
 must be met by these experts, t_ting o_ both animals and humans to
 _o Before an uarasrketed new drug establish the dr_'s safety and affectiveness 11. The Food and Drug Adm_nlstratiot
 may be tested on humans, aa for _t_ proposed usaa. _n addition, the s_r_or evaluates the safetF of a substance
 reuse submit date and maaufactus'In_ fl'troughou_ the inves_gafional new d.ru_
 investigational new drug exemption
 (IND) must be applied for and approved controls, d_t_on_tr_ting that standards ,)f [_ND) process, and as part of the new
 by the Food and Drug AdmL_is_at_o_ Identity. _tr_th, quality, and purity w_i_ b_ drug application (NDA) approve| status.
 met. _2, The sponsor o_ an IND is
 This approval i_ required for both sad concludes by saying:
 pharmaceutical companies who responsible for supp|ymg FDA wqth the
 ultimately intend to raarket the drug and Thus, the _k of an approved NDA for a results of preciinical (animal} studies
 d_ substance Issds FDA to find that a which show that there will b_ no
 physicians or researchers who are subs_nce lacks an "scceptad medic_ _se in unreasonable hazards in initiating
 interested In using the drug solely aa a treatment" for tw_ _soaa. First it a_e cf _he studies in humans with the drug. At a
 research tool. These IND requirements drJg is unl_wfu_ whenever Interstate
 are necessa_ to comply with provisions corneas is Involved. medical usa of _a minimum, these initial studies must
 of the Federal Food, Drug and Cosmetic drub e_nao_ be classified a_ accepted. Include a pharmacological profile of the
 Act. its implementing regulations, sad _coa_ _n the _bsence of the data ne_,sa_ drug. acute toxicity studies in severer
 •
 the basic ethi_I principles _ardin8 _e for approve| of an NDA_ the a_e_c'y has no species, and shore-term toxlc_ty studies
 conduct Of research in human sub_ect_ basis for c_cludin$ that medica_ use of the ranging _rom two weeks to throe
 These standards were established as a _ in treatment can be con_de_d raontheo
 result of the Nuremberg _ats in the acceptable by ra_:lica_ standards. _3o A substance ts not deemed "safe"
 Nuremberg Code, and later r_iter_ta_ L_ 7. In _a_ch _1_8_, there was _o by the Food and Drug Administration
 the Helsinkl Agreement of _5. reference in the filas of the Food and unless FDA., after a review of scientific
 S. ]n order for an IND to be inltJ|dly Drug Admh_Is_ratlon to the substsn_ data submRted durir_ the IND proc_s_
 ..... approved by the Food and Dru_ 3,_methylenedio_ym_thamphetamiae haa determined that the substance can
 Administration, the sponeo_ _ust _tvff_MA]: them were no investlgati|_nal be given to humans without Irrevarsib{c_
 provide informati_ re_ardin$ the new drug applications or approvals_ harm.
 composition, so_e and ma_ufac_n8 them were no new drug applications or _4. No sclenti_c date was supplied to
 safeguards of the substance: animal approvaJs_ _nd there was no _ndicatlon the Food and Drug Ach_dnistration
 toxicity studies showing that the that any sponsor had informed FDA that which would demonstrate the safety of
 substance will not produce Ln'_ver_ible such submisslnn weald be for_hoomlng. MDM,A, and a review of the scientific
 damage at the doses Use_ and that It was also determlned at that time that literature led an FDA official who