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Executive Summary

Miles' promotion of its Nimotop (nimodipine) calcium channel blocker for the unapproved indication of cerebral ischemia is the subject of a Feb. 21 warning letter from FDA's Division of Drug Marketing, Advertising and Communications. The company was also cited for promoting "the concept that Nimotop exerts unproven beneficial effects at the cellular level." Nimotop is approved for treatment "of neurological deficits due to spasm following subarachnoid hemorrhage." The warning letter cites an ad in the October 1991 issue of Neurology that contains "statements and regard to the use of Nimotop for unapproved uses, i.e., the prevention or treatment of cerebral ischemia not specifically related to subarachnoid hemorrhage." The ad, FDA said, is "representative" of the company's "current promotional campaign" for Nimotop. In addition to halting the current campaign, "we request that Miles agree to submit its proposed advertising and promotional materials for Nimotop to this division for preclearance for a period of one year," the warning letter states. The drug advertising division has sought preclearance of promotional materials in several recent cases. Syntex entered into a consent decree in October calling for two years of preclearance for its Naprosyn nonsteroidal anti-inflammatory drug promotional materials ("The Pink Sheet" Oct. 14, p. 6). A broader two-year preclearance was agreed to by Bristol-Myers Squibb for its oncology products in May ("The Pink Sheet" June 3, p. 6). The warning letter directs Miles to "suspend immediately all violative promotional activities for Nimotop that characterize the product as" useful for cerebral ischemia other than those specifically related to subarachnoid hemmorhage; "require the return and destruction of all materials that state or suggest such unapproved uses"; and "inform this office specifically of all relevant actions taken to recall violative materials." "In the absence of data clearly establishing the mechanism of action of Nimotop," the warning letter directs Miles in future advertising and promotional campaigns to "focus upon [the drug's] proven effects as demonstrated primarily by adequate and well- controlled clinical studies"; "make clear the specific use for which the drug is indicated"; avoid promoting the "administration of the drug for other unproven and/or unapproved uses"; and "submit one copy of each piece of Nimotop promotional material that remains available for use." The warning letter also speaks to FDA's interest in regulating industry-sponsored scientific interchange. The ad division directs Miles to "provide specific information regarding all scientific, educational or other purportedly nonpromotional activities concerning nimodipine, conducted or sponsored by Miles or in Miles behalf, from Jan. 1, 1991 to the date of issuance of this letter." The division also directs the company to "describe all scientific, educational, or other purportedly nonpromotional activities concerning Nimotop to be conducted or sponsored by Miles or in Miles' behalf, within the next six months." "We note that our records do not indicate that Miles has submitted all of its advertising and promotional materials for Nimotop" as required by regulations, the letter says. "We request that Miles provide documentation to show that all such regulatory submissions for Nimotop were timely filed. In the event such filings were not made, Miles is required to explain why they were not made, and what corrective action is being taken to assure that, in the future, such submissions are timely filed." Miles maintains that its advertisements were "well within the approved indication." The company said it intends to defend its position in face-to-face talks with the division. In the meantime, the company has asked its sales reps not to use the materials in question. Nimotop was approved at the end of 1988 and was the first treatment for subarachnoid hemorrhage. Miles is seeking to expand nimodipine's indications; the company is currently conducting Phase III studies of the drug in Alzheimer's patients.

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