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LEMMON’s "DEAR DOCTOR" CORRECTIVE LETTER FOR ORAP PROMOTIONS

Executive Summary

LEMMON's "DEAR DOCTOR" CORRECTIVE LETTER FOR ORAP PROMOTIONS was mailed out to 94,000 physicians on Oct. 1. FDA requested the "Dear Doctor" letter in a warning letter issued May 7 that cited Lemmon's Gate Pharmaceuticals subsidiary for misleading promotions ("The Pink Sheet" May 25, p. 6). Orap is indicated for the second- line treatment for motor and phonic tics in Tourette's patients. Lemmon and FDA have been in negotiations since May about the company's response to the issues raised in the warning letter. The "Dear Doctor" letter from Gate Executive Director Barry Edwards specifies those aspects of Orap advertising and promotional materials that FDA found to be false and/or misleading. FDA felt that Orap ads/promos did not adequately communicate either that Orap is intended only as a second-line treatment or the risk information contained in the approved labeling. Advertising claims that Orap has a better safety and efficacy profile than haloperidol were considered improper as well. The "Dear Doctor" letter recaps for physicians Orap's approved labeling, which states: "Orap (pimozide) is indicated for the suppression of motor and phonic tics in patients with Tourette's Disorder who have failed to respond satisfactorily to standard treatment. Orap is not intended as a treatment of first choice ...." Full labeling is enclosed with the "Dear Doctor" letter, and a company telephone number is provided to physicians who may have additional questions. Orap was one of five active warning letters concerning advertising and promotion before FDA. Other products that have generated recent warning letters are Miles' Nimotop, ICI's Zestril, Hoechst-Roussel's Lasix and, most recently, Marion Merrell Dow's Carafate. Miles and FDA have resolved the problem concerning Nimotop ads and promotions. As part of the resolution with FDA, Miles has agreed to submit all of its advertising and promotional material to FDA for preclearance for a period of one year starting from the date of the warning letter. A Sept. 25 letter from FDA Division of Drug Marketing, Advertising and Communications Acting Director Cheryl Graham, MD, states: "In view of Miles' cooperation in resolving the issues raised in the warning letter, DDMAC has determined that no further action on this matter is required at this time." Miles received the warning letter Feb. 21 for a journal ad that promoted Nimotop (nimodipine) for the unapproved use of preventing or treating cerebral ischemia not specifically related to the approved indication of subarachnoid hemorrhage. Miles at the time maintained that the ads were "well within the approved indication" ("The Pink Sheet" March 2, p. 12). ICI's Stuart Pharmaceuticals says it is still in discussions with FDA regarding the warning letter issued March 2 for Stuart's Zestril (lisinopril) to "get the issues raised by [FDA] in that warning letter resolved as quickly as possible." Advertising and promotional materials for Zestril made superiority claims over other angiotensin-converting enzyme inhibitors based on Zestril's once-daily dosing. FDA asked in the warning letter that Stuart send out "Dear Doctor" letters and agree to six months of preclearance for all promotional materials ("The Pink Sheet" March 23, p. 12). Hoechst-Roussel also has not yet resolved its warning letter case. FDA sent a warning letter June 24 concerning the loop diuretic Lasix (furosemide), alleging that promotional materials for the drug contained false superiority claims over generic products. FDA asked that Hoechst send out a "Dear Doctor" letter by direct mail and through paid ads in the 12 medical journals having the greatest U.S. circulation ("The Pink Sheet" July 13, p. 8). The firm says it is "continuing to work with the FDA to resolve the issues they've raised." The most recent warning letter went out Oct. 13 to Marion Merrell Dow for its anti-ulcer drug Carafate (sucralfate). The company has received an extension for its formal response to the agency.
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