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ROXANE MARINOL SUPERIORITY CLAIMS TO COMPAZINE DRAW WARNING LETTER

Executive Summary

ROXANE MARINOL SUPERIORITY CLAIMS TO COMPAZINE DRAW WARNING LETTER from FDA on June 22. Roxane Labs "makes comparative claims to conventional antiemetic therapies" by asserting that Marinol (dronabinol) has a superior efficacy profile to that of SmithKline Beecham's Compazine (prochlorperazine). The warning letter cites advertising making these claims that appeared in the March 1993 and June 1993 issues of the Journal of American Clinical Oncology. The ASCO journal ad is headlined: After chemotherapy, send them home with Marinol." The ad claims that Marinol is "more effective than Compazine," can be used as "take-home protection against delayed- onset nausea and vomiting" and is "effective for a wide range of patient types and chemotherapeutic agents." Roxane's advertisements are in violation of the FD&C Act, the warning letter states, because they "promote unapproved uses of Marinol" by failing to disclose that the drug is approved as a second-line therapy for "patients who have failed to respond adequately to conventional antiemetic treatments." The ads are false and misleading additionally because they imply that Marinol is "approved for use in a broader population than is indicated in the approved labeling," the agency letter states. Marinol, co-promoted by Roxane and Unimed, was approved in 1985 for use as a second-line agent in preventing nausea and vomiting in patients who fail conventional antiemetic treatments. Last December, the drug, which contains delta-9-THC, the active ingredient in marijuana, received a supplemental approval for the treatment of anorexia associated with weight loss in people with AIDS. Draft revised labeling was submitted to the agency at the time of the supplemental approval. In the letter, FDA's Division of Drug Marketing, Advertising and Communications calls for Roxane to cease the promotional campaign for Marinol, to submit a plan for corrective action and to prepare a "Dear Healthcare Professional" letter specifically stating the limitations on the approved indication for the use of Marinol. The letter is to be disseminated by direct mail and by publication in all medical, pharmacy, or other healthcare journals that contained advertisements for Marinol within 12 months prior to the issuance of the warning letter. The ad appears to have been placed only in the ASCO journal. Roxane has until July 8 to respond to the warning letter. The corrective action requested for Marinol would appear to be similar in scope to the "Dear Doctor" letters Lemmon was required to distribute last year for "false and misleading" promotion of its Tourette's Syndrome drug Orap (pimozide). FDA cited Lemmon's Gate Pharmaceutical subsidiary in a May 1992 warning letter for not adequately communicating that Orap is a second-line therapy or the risk information contained in approved labeling. Lemmon sent out 94,000 "Dear Doctor" letters on Oct. 1 ("The Pink Sheet, Nov. 9, 1992, T&G-3). The Marinol warning letter also asserts that the ad is false and/or misleading by the use of the claim "Take home protection. . ." which is inconsistent with the draft revised labeling indication that states that "patients should remain under the supervision of a responsible adult during the initial use of Marinol." Part of the reason for this restriction is because "a substantial proportion of patients treated with Marinol can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic treatments," the letter states FDA also takes Roxane to task for the readability of its ad copy as well as its failure to adequately warn of dangers associated with the drug. FDA cites Roxane's ad as "lacking in fair balance" and "misleading" because it does not "adequately disclose the risk information in the Warnings and Precautions sections of the draft revised product labeling." For example, FDA pointed out, the "Warning: May Be Habit Forming" statement appears in "very small subscript compared to any other printed matter in the ad, including the footnote (which also is presented in an inadequate type size). This presentation trivializes the warning statement," FDA said. The letter continues that "the body of the ad does not present information relating to contraindications and side effects with a prominence and readability reasonably comparable to the information about indications and effectiveness." Additionally, the letter notes, the ad does not warn the reader that, as stated in draft revised labeling, "Marinol should be used with caution in patients with cardiac disorders...a history of substance abuse...with mania, depression, or schizophrenia" or "patients receiving concomitant therapy with sedatives, hypnotics or other psychoactive drugs."
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