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Executive Summary

STUART's STUARTNATAL 1 + 1 Rx MULTIVITAMIN/MULTIMINERAL product for pregnant and lactating women could be reviewed by FDA under a DESI-type or OTC-type evaluation, Stuart parent, ICI Pharmaceuticals Group, suggested in a March 1 letter to FDA. The company recommended that FDA allow continued marketing of Stuartnatal 1 + 1 and other prescription multivitamin/multimineral products until such a review can be completed. ICI's suggestion is in response to recent notification from FDA that Stuartnatal 1 + 1 is subject to regulatory action because it does not have an approved NDA and differs from prescription products marketed on or before Nov. 13, 1984. Under FDA's Prescription Drug Compliance Policy Guide, unapproved prescription products are exempt from immediate regulatory action only if their formulation does not differ from products marketed on or before Nov. 13, 1984. As an alternative to a new review of prescription multivitamin/multiminerals for pregnant and lactating women, ICI requested that the agency amend the policy guideline to allow marketing of those products that do not contain different ingredients, or ingredients in higher strengths, than multivitamin/multimineral products marketed either before Nov. 13, 1984 or the date of the suggested amendment to the policy guideline. "The proposed amendment would allow the marketing of a new or reformulated oral prescription multivitamin/multimineral product if it met for criteria," Stuart explained: (1) "the new or reformulated product . . . contains only vitamins and minerals that were contained in one or more prescription . . . products indicated for pregnant and lactating women that were on the market on or before a specified date"; (2) "the amount of each vitamin or mineral in the . . . product is within the range of amounts of that vitamin or mineral contained in the reference products or recognized by FDA as appropriate in its own past evaluations of such products"; (3) the product "contains no inactive ingredient not customarily used in the reference products"; and (4) the product is "labeled as a prescription drug and is indicated only for vitamin and mineral supplementation throughout pregnancy and during the postnatal period." ICI maintained that the policy guideline, as it is currently written, should not be applied to multimineral/multivitamin products because minor formulation changes are often made to reflect new medical knowledge. "Changes in existing products, while unusual for prescription drugs generally, are simply a reflection of the nature of this type of multivitamin/multimineral product," ICI said. "The products are regularly reviewed and modified as appropriate to reflect developments in medical and nutritional learning about the optimal dietary needs of pregnant and lactating women." As an example the company noted that it lowered the amount of vitamin A contained in Stuartnatal 1 + 1 to respond to concerns from physicians about high levels of Vitamin A. ICI pointed out that the formulation change "could be proscribed by the Prescription Drug Policy Guide," even though other multivitamin/multimineral products marketed before 1984 contained the same amount of vitamin A now in Stuartnatal 1 + 1. ICI noted that if FDA does not allow continued marketing via a new policy guideline, or in the interim, while a review of the products is undertaken, "the very great majority of prescription oral multivitamin/multimeral products now sold, would in FDA's view, be subject to enforcement action under existing policy." The options "available to marketers, i.e., reformulate to 1984 [formulations] or OTC formulations [e.g., those with .8 mg or less of folic acid] or seek approval of an NDA, are simply not viable," ICI asserted.

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