REED & CARNRICK KWELL PATIENT INSERT MODIFICATION REQUESTED

Executive Summary

REED & CARNRICK KWELL PATIENT INSERT MODIFICATION REQUESTED by FDA's Dermatologic Drugs Advisory Cmte. at its Nov. 5 meeting. Cmte. members criticized the company for not incorporating the cmte.'s previous recommendations into the patient labeling. The cmte. agreed that FDA agreed "generate a synopsis of the agreements" made at their meeting in October 1983 and delay adoption of the proposed patient insert. At the cmte.'s October 1983 meeting, Reed & Carnrick VP-R&D Fred Mallreath told the cmte. its patient information would be based on a pamphlet on treating lice distributed by the Natl. Pediculosis Assn. According to assn. representative Bill Nowak, Reed & Carnrick's patient insert does not include specific warnings against misuse, such as "avoiding a hot bath or shampoo immediately preceeding treatment"; avoiding treatment of "an individual with excoriated scalp or neck area"; and the necessity of "treating over the sink rather than in the bathtub or shower to limit the absorption of lindane." The proposed Kwell (lindane) patient insert included a rebate offer for another product. The cmte. told Reed & Carnrick promotional efforts of that sort are not acceptable. Explaining the agency's position on such product promotion, FDA Anti-Infective Drug Products Div. Director John Tabor, MD, said: "In general, we go to very great efforts to keep promotional efforts out of physician inserts, and I would certainly think the same would apply to patient package inserts." Reed & Carnrick's McIlreath responded that the company had mistakenly included the rebate offer in the patient insert. "I was just as surprised and upset to find that in there as you," McIlreath said. "I don't know what it is doing there . . . Obviously, it was a clerical error."