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Executive Summary

PEDIATRIC USE LABELING: SUPPLEMENTAL NDA SUBMISSION WITHIN 12 MONTHS of publication of FDA's final rule on updating pediatric use labeling is recommended by Merck Research Labs. In recent comments on FDA's proposed rule for pediatric use supplements, Merck suggested that "within 12 months of final publication of this rule, manufacturers must submit a supplemental [NDA] containing the revised package circular." FDA is proposing that the final rule become effective one year after publication and that after that date products whose labeling is not in compliance with the rule will be misbranded. Merck maintains that FDA's "timeframe is unreasonable since it is clear that it could take up to one year to modify all package circulars and submit them to FDA for approval." The company "estimates that it will take at least one full year to revise more than 71 circulars to comply with this new proposal." In the proposed rule, published in the Oct. 16 Federal Register, FDA encouraged companies "to consider what labeling revisions, if any, will be necessary before FDA publishes the final rule, and to submit supplements proposing any revised labeling at the earliest opportunity." Generic drug firms will have four months after any labeling changes in the innovator products to bring their labels into compliance. Merck added that "it is very unlikely, given the current backlog of 'routine' supplements at FDA, that FDA would be able to approve all the supplements submitted to accomplish the intent of this rule within one year." The firm pointed out that "a similar proposed amendment requiring changes in the format and content of labeling for geriatric patients is pending and expected to be published in final form before finalization of this proposal for pediatric labeling changes." FDA has predicted that this year it would issue a final proposal that would require labeling for new and marketed drugs to include an evaluation of available data on use in geriatric populations ("The Pink Sheet" July 6, p. 5). Merck suggested that FDA "consider allowing division level, rather than office level approval of these labeling supplements in order to expedite its part in the implementation of this proposal." The company also recommended that "in order to avoid confusion among prescribers, FDA might use its already established liaison with the American Academy of Pediatrics' Committee on Drugs to identify therapeutic categories of products where there is the most critical need for use in children and recommend that these therapeutic classes be relabeled first." FDA could then "review related labels from different companies at the same time and coordinate the timing of the implementation of changes in label language for similar agents." FDA along with AAP's Committee on Drugs also "might consider defining age categories or groups that should be used consistently for pediatric labeling of pharmaceutical and biological products or alternatively require that age groups be clearly defined numerically in each product's labeling," Merck said. If commonly accepted definitions exist, "it would be very useful to include these definitions in the reproposal of this rule, for the benefit of sponsors who may not have experience with products used in children."

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