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FDA REVIEWING ALL INJECTABLE DRUGS FOLLOWING E-FEROL INCIDENT

Executive Summary

FDA REVIEWING ALL INJECTABLE DRUGS FOLLOWING E-FEROL INCIDENT "to guard against the occurrence of similar incidents in the future," FDA Acting Com. Novitch told Rep. Weiss' (D-NY) House Govt. Operations/Intergovernmental Relations Subcmte. May 4. "We will perform an in-depth review of vitamin E preparations intended for medical use in infants, focusing on ingredients, dosages, routes of administration, and the relationship among these factors," Novitch said. "We will also take a critical look at all drugs for injection, including both their active and inactive ingredient -- particularly drugs used in infants." Novitch's testimony followed the April 10 recall of E-Ferol by distributor O'Neal Jones & Feldman. The product has been linked to 38 infant deaths and serious adverse reactions in more than 40 premature babies. The Weiss hearing could have major implications for the generic industry, which has argued that FDA should be more flexible in approving drugs similar to already marketed products. The issue, for example, is addressed in the draft Waxman ANDA/patent bill, which allows mfrs. to petition FDA for approval of products "whose active ingredients, route of administration, dosage form or strength differ from those of a listed reference drug." At the hearing, Novitch stated that "although the generic class approach to imposing new regulatory requirements on already marketed drugs is suitable for most products," in retrospect it does not seem to have been suitable for E-Ferol. The I.V. formulation differed from marketed intramuscular products "in enough respects that it should have been viewed as an essentially new product, requiring an approved NDA before marketing," Novitch said. Novitch noted that the agency will also be "examining internal procedures to ensure that inquiries about specific products are adequately reviewed to determine if action is necessary." He said the Centers for Disease Control began receiving reports from two hospitals in March suggesting a possible association between use of E-Ferol and deaths in premature infants, and passed the information to FDA on April 2.
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