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FDA WILL CONSIDER REQUESTS ON USE OF RED 3 IN DRUGS

Executive Summary

FDA WILL CONSIDER REQUESTS ON USE OF RED 3 IN DRUGS of short supply if manufacturers are seeking approval of formulation changes, FDA said in a March 21 letter to four drug manufacturers' trade associations. The letter was sent to the Pharmaceutical Manufacturers Association, the Nonprescription Drug Manufacturers Association, the Generic Pharmaceutical Industry Association and the National Association of Pharmaceutical Manufacturers. For drugs that are potentially in short supply, "FDA will consider requests from manufacturers who seek to add previously certified FD&C Red No. 3 or its lakes already on hand to their approved drugs during this six-month period while they are taking the steps necessary to have formulation changes approved." On Jan. 29, FDA terminated the provisional listing for Red 3 in externally applied drugs and cosmetics and lakes of Red 3 for all uses. FDA's letter clarifies its procedures for discontinuing the use of Red 3 in drug products. The agency's final rule on use of Red 3, published in the Feb. 1 Federal Register, has elicited concern in the drug industry. Mylan filed a Feb. 22 citizens petition requesting that FDA adopt a 90-day "phase-in period" during which manufacturers can use existing supplies of Red 3-containing coatings to finish in-process products ("The Pink Sheet" March 5, T&G-12). In its letter, FDA noted that since regulations require the approval of a supplemental application to add new colors to drug formulations, it is adopting three transitional policies for the use of Red 3 to minimize disruption of drug supplies. First, FDA will consider on "a case-by-case basis requests by manufacturers and others for additional steps to ensure the continued supply of approved drugs," the letter says. Mylan seeks to modify the final rule to allow substitution of a replacement color without agency pre-approval. During the next six months, FDA said, it will focus enforcement efforts on illegal products that can be removed from the market without disruption. Companies that submit requests for measures to ensure continued supply of their drugs "should demonstrate to FDA why immediate regulatory action against specific drugs would be contrary to the public interest." FDA stated that "if other steps are found inadequate to ensure the continued marketing of an approved drug, the agency will consider a request...for a waiver" of the requirement for supplemental approval of a formulation change. "Under such a waiver, the submission of a complete supplement containing the necessary three months' stability data will be deemed approved." A waiver request must be accompanied by a signed agreement that the firm will recall the product if informed by FDA that the supplement has been found deficient. FDA said it will secondly "assign a high priority to reviewing manufacturers' requests for the review and approval of all supplemental applications proposing new formulations involving color changes." FDA requires the submission of a minimum of three months of stability data for new formulations. However, to expedite the process, the agency said it will allow firms initially to submit two months of stability data to permit an early start for FDA review. Firms must follow up with submission of the third month's stability data. Manufacturers also need to file requests for expedited review. FDA additionally will allow manufacturers to "exhaust supplies of drug products or components, including capsules, colored powders, and coating solutions to which Red 3 or its lakes was added prior to Jan. 29, 1990."
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