norml01 - Page 16



Page 16 Previous , Next , Original Image
Return to Index

 |
 g Id_ at 1323. Surely, the notice provided herer which was con-
 i siderably less informative than that given in McLouth, was also
 inadequate° Had DEA informed the public in advance that it
 I intended to adopt a multi-factor FDCA-based test for determining
 whether a substance has an accepted medical use in treatment, it
 I is likely that many more persons would have participated in the
 i proceedings. The notices informed the public that DEA was con-
 sidering controlling MDMA and rescheduling marijuana; they did
 I not indicate that at the same time the agency would promulgate a
 generally applicable rule defining the "characteristics '_ of a
 i substance that has an _accepted medical use in treatment in the
 i United States. '_ Se__e J.Ao 50_
 The Administrator's adoption of FDA rules is also vul-
 g nerable on this ground° While those regulations were duly
 promulgated by the FDA after notice and an opportunity for public
 comments nothing in the notices would haws alerted a reader that
 i those same regulations would be applied by the Administrator in
 determining whether a drug has an accepted medical use in treat-
 i ment within the meaning of the CSAo See New Drug and Antibiotic
 Requlations, 47 Fed. Reg. 46_622 (Oct° 19, 1982); Pro_sed New
 i Druq_ Antibiotic_and Biologic Drug Product Requlations, 48 Fed°
 l Reg. 26,720 (June 9_ 1983).
 Respondent's fall-back argument is that any procedural
 i error was harmless_ because Petitioners did not describe
 '_specific evidence that they would have otherwise produced."
 Resp. Br_ at 26. Assuming Respondent is correct in suggesting
 i that the Administrator's standard is a rule, McLouth Steel




Previous , Next , Return to Index