vol1 - Page 372

 respect for the opinions of the Courts_ the intent of the state
 legislatures and Congress_
 ....... In short, the Alliance looks outward to the community_
 to those most intimately involved in treatment -- physicians and
 their patients -= to policy makerst politicians, health care
 professionals, scientists_ laymen, expez_s, lawyers and other
 points of reference. By frying the question of a drug's
 acceptance into medical use in the familiar legal language of
 medical malpractice_ the Alliance_s standard ultimately relies on
 society-at-large, as reflected in the jury, the courts and the
 legislatures and by the practitioners and patients themselves.
 This reference to many different sources within the
 community makes sense in the context of a highly pluralistic
 society where the practice of medicine often involves strong
 differences of opinion over the proper conduct of treatment.
 In sharp contrasts DEAn in clear defiance of the
 Courts, promulgates a brittle, contrived efficacy-based standard
 predicated on an unspecific, highly inflated construction of FDA
 regulations used to govern the commercial marketing of
 pharmaceutically produced products° DEA looks inward and
 advocates a standard which ignores society-at-large, the
 realities of medical practice, the intent of the state
 legislatures and of Congress, and the results of federally
 authorized research.
 DEA's artificial standard ignores pressing human needs,
 and rests on little more than a dogmatic adherence to a catechism
 of controls°which bear little resemblance to the realities of
 - 65 -