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Executive Summary

DEA SCHEDULE II PRESCRIBING LIMITATIONS FOR DRONABINOL are being questioned by the American Medical Assn. (AMA) and the American Pharmaceutical Assn. (APhA) on the grounds that they could set a precedent for unnecessary federal intrusion into medical and pharmacy practice. DEA (Drug Enforcement Administration) has proposed moving the synthetic marijuana from Schedule I to Schedule II, on the condition that it be prescribed and dispensed only for the treatment of nausea and vomiting associated with cancer chemotherapy. In switching the drug to Schedule II, which allows for Rx pharmacy distribution, DEA is proposing to make any prescribing or dispensing beyond the indicated use a violation of the Controlled Substances Act (CSA). While expressing its support for the rescheduling of dronabinol from Schedule I to Schedule II following the drug's approval by FDA (Unimed's NDA for Marinol was approved in June 1985), AMA commented to DEA that it "vigorously" opposed "restricting the therapeutic use of dronabinol (or any other FDA-approved drug) to the approved indications." Both AMA and APhA expressed concern in particular that the proposed restriction would subject the physician or pharmacist to criminal prosecution for prescribing, administering or dispensing of dronabinol outside of the labeled indications. Both associations noted that this would be the first time such a restriction had been imposed on the use of an approved drug. AMA maintained that it was current FDA policy, as the proposed IND rewrite explicitly states, that once a drug is approved for marketing, a physician may prescribe it for an unlabeled purpose; that the labeling is intended to advise the physician rather than to restrict him. The association added that in light of the "extremely limited" indication for use of dronabinol, restricting use of the drug to the labeled indication would be particularly inappropriate, as it would, for instance, restrict its use even as an anti-emetic for some cancer patients, such as those suffering from radiation therapy. It would be inappropriate to single out dronabinol for precedent-setting restrictions, AMA argued, as a diversion problem has not been apparent during investigational use of the drug. Also, the association noted, other Schedule II drugs such as cocaine and opioids, which are not restricted as to legitimate medical use, "pose a significantly greater potential for diversion, abuse and addiction than does dronabinol." AMA maintained that the existing tools at DEA's disposal were adequate to prevent the diversion of dronabinol and other Schedule II drugs. Along with the quota system and the Automated Reports and Consolidated Orders System, AMA noted that the Prescription Abuse Data Synthesis (PADS) model, developed by AMA in conjunction with DEA and other interested parties, provides "a highly effective mechanism . . . for identifying practitioners who inappropriately prescribe or dispense drugs that are subject to abuse." AMA noted that the PADS model is now being used in more than 20 states and helps state officials curb prescription drug abuse by more effectively identifying the sources of illicit drug diversion. In noting at the Natl. Assn. of Pharmaceutical Mfrs. (NAPM) annual meeting Jan. 14 that the agency had received the comments on the proposed rescheduling of dronabinol, DEA Diversion Control Deputy Director Ronald Buzzeo reaffirmed the agency's position that it was bound by commitments under the international psychotropic drug convention to maintain strict limits on the marijuana derivative and that these commitments necessitated that the prescribing restrictions be applied. If the agency did not have the authority to apply them, Buzzeo said, "we would have to look very carefully at the pending rescheduling." AMA maintained in its comments to DEA that the fact that dronabinol now has a currently accepted medical use in the U.S. is important new information which warrants a request by the U.S. for a review of the decision to schedule THC in Schedule I under the Convention. "We urge the DEA, through the Secretary of State," AMA said, "to request that such a review occur at the next meeting of the Convention."

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