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Rx PATIENT INFO COULD BE INCLUDED IN THREE-PART DRUG LABELING

Executive Summary

Rx PATIENT INFO COULD BE INCLUDED IN THREE-PART DRUG LABELING, FDA Anti-Infectives Division Director Murray Lumpkin, MD, suggested at a Sept. 10 Drug Information Association workshop in Arlington, Va. The time may be right for FDA and industry to consider "whether we need to look at the idea of a new tripartite type of labeling," Lumpkin said. The three parts of labeling would include a "consumer product summary," a "physician product summary" and a complete "product information sheet." The FDAer emphasized that "this is not FDA podium policy. These are truly personal thoughts and should be taken as such." Lumpkin suggested that the consumer product summary be "a specific part of the label that would be for consumer education, both about the drug and about appropriate use. It would be a part of the label that would be submitted with the NDA and approved at the time of the drug approval." Furthermore, Lumpkin added, "if, indeed, we ever want to open Pandora's Box...clearly it could be a part of the label that would be used to define what would be appropriate or inappropriate consumer advertising." "Whether we tend to admit it or not," the current package insert "is used by consumers," Lumpkin said. "Those of us who are responsible for labeling in this country have to admit that in this respect we have, perhaps, done a disservice. We have not addressed the issue of consumer use of approved labeling as judiciously and as effectively as we could have." While he declared that his remarks were not agency policy, Lumpkin's comments dovetail with recent public discussions by Commissioner Kessler and his deputies on patient labeling. A top aide to Kessler announced an agency "initiative" last December to promote pharmacy distribution of patient information. The agency also has been urging companies to expand their Information for Patients section of labeling ("The Pink Sheet" Dec. 16, 1991, p. 7). Kessler himself publicly lauded industry-initiated patient education programs at an Aug. 31 meeting of the National Association of Chain Drug Stores ("The Pink Sheet" Sept. 7, p. 9). Lumpkin discussed patient education as part of a more general critique of the current package insert format. By seeking to include all relevant scientific information in the label, "we've created a document that, perhaps, is trying to be all things to all people," he maintained. "The information is really not getting to the people whom we've intended to get it." In addition to a consumer label, Lumpkin suggested a physician product summary that would be similar to the current "brief summary" required for printed promotional materials. The goal would be to "pick out the various parts [of the current package insert] that are immediately and uniquely necessary for the appropriate and safe use of the drug in an individual clinical practice setting." The final portion of Lumpkin's proposed "tripartite" label would be "a product information sheet which would include the other parts of the [current] label," Lumpkin said. He noted that this would preserve the package insert's function of protecting companies from liability and defining what professional promotional claims can be made. Lumpkin also suggested that the adverse reactions section of labeling should be clarified. "Over the years after a drug is approved, the labels kind of metastasize in the adverse events section," Lumpkin quipped. The lists of adverse reactions seen in trials and reported post-marketing "is really a very poor communication tool for trying to tell the physician what to expect reasonably can happen if he or she chooses to [prescribe] this drug," he said. Lumpkin proposed that listed adverse reactions be clearly divided into those found in placebo-controlled trials, those found in active-controlled trials and those found after marketing, with "legitimate denominators" spelled out whenever possible. The FDAer indicated several other areas of labeling where he believes the agency's approach is evolving. Among "issues" he cited were: "including the dosage form in the established name of the product"; how much pharmacokinetic data developed in clinical trials is relevant to the ultimate intended use of the drug; how to express doses used in animal carcinogenicity studies as compared to the relevant human doses; and what "new testing methodologies" may be appropriate for determining pediatric doses.
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