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MYLAN SEEKING RED 3 PERMANENT LISTING EXTENSION

Executive Summary

MYLAN SEEKING RED 3 PERMANENT LISTING EXTENSION in a citizens petition filed Feb. 22 by the generic drug firm. Mylan's petition asks FDA to adopt a 90-day "phase-in period" during which manufacturers can still use existing supplies of tablet coatings containing the color additive FD&C Red No. 3 to finish in-process drug products. On Jan. 29, FDA ended the provisional listing for Red 3 in externally applied drugs and cosmetics and said it will proceed with the termination of the dye's permanent listing for use in food and ingested drugs. * Mylan also seeks to alter the final rule on the additive to allow companies to substitute a replacement color without agency preapproval. The Feb. 1 Federal Register notice terminating Red 3 use requires manufacturers to file ANDA supplements in order to replace the banned color in their products. The generic manufacturer complained that the agency's ANDA approval process is in disarray following the congressional investigation of the generic drug approval process. "The agency, according to accounts in the media and confirmed by FDA spokesmen, faces a backlog of supplements which currently exceeds 2,000," Mylan's petition states, concluding: "it is unrealistic to believe the FDA will act expeditiously in reviewing supplements...filed in response to this rule." Awaiting specific agency approval of substitutions for Red 3 for individual products could thus result in one change to product appearance when the banned color is removed and a second change when a replacement color is later approved, the firm pointed out, with resulting pharmacist and customer confusion. The Red 3 final rule specifies that no recall or destruction of products to which the color additive has already been added is required "because any health risks posed by FD&C Red No. 3 are extremely small," the agency said. The notice applies to all products manufactured after Jan. 29. Separate objections to the preapproval policy for Red 3 substitutes were voiced by the Washington, D.C. law firm McKenna, Conner & Cuneo on behalf of an unspecified "generic manufacturer." The Feb. 26 comments call the preapproval requirement "fundamentally unfair, because prior provisional listing termination notices permitted a color additive substitution without preapproval and...because [the change in policy] was implemented without advance notice." Red 3 was banned as a carcinogen under the Delaney Clause. However, FDA noted in the Red 3 final rule that it is "concerned about the rigidity of the Delaney Clause and has proposed a change on a similar risk assessment issue involving pesticides in foods as part of its food safety initiative announced last fall." HHS Secretary Sullivan pointed out that "there have been laboratory studies which showed that very high doses of Red No. 3, administered directly in the diet, caused cancer in rats. In these circumstances, small as the risk is, we have no choice under the law but to end the provisional listing of this product." The Pharmaceutical Manufacturers Association and the Nonprescription Drug Manufacturers Association have predicted little impact on drug products, since alternative formulations are already available to substitute for the relatively small amounts of FD&C Red No. 3 still in use. The associations reported that most of their member companies have made contingency plans in anticipation of the ban. Potential substitute dyes for ingested drugs include FD&C Red 40 and D&C Reds 6, 7, 27, 28, 30, 33 and 36, PMA said. Potential alternatives for externally applied drug products are Red 40, and D&C Reds 4, 17, 34 and 39. The two most likely substitutes are Reds 33 and 40.
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