BASF SEEKING TO INCLUDE PEG-25 PABA IN SUNSCREEN MONOGRAPH

BASF SEEKING TO INCLUDE PEG-25 PABA IN SUNSCREEN MONOGRAPH, although the ingredient has not previously been used in the U.S. In a May 25 citizen's petition submitted to FDA on behalf of the West German chemical supply firm, BASF requested that the agency reopen the administrative record of the OTC Sunscreen Products Review to consider the inclusion of ethoxylated ethyl-4-aminobenzoate (PEG-25 PABA) as a Category I sunscreen ingredient. BASF believes the ingredient is "quite effective" and "attractive from a cost standpoint," according to the firm's Washington D.C. attorney, Stephen Mahinka (Morgan Lewis & Bockius). BASF acknowledged that FDA generally excludes from the OTC monograph review any substance not marketed in the U.S. prior to Dec. 4, 1975, but the petition argues that such "uniform application of this interpretation in all circumstances is inconsistent with the Agency's statutory authority for regulating OTC drugs." The petition maintains that the FD&C Act does not specify the marketing of a product in the U.S. as a condition for consideration as a non-"new drug." "The statute neither requires that a GRAS/E status be based on marketing of a substance in the United States nor on 'to a material extent or for a material time' in the U.S.," BASF argued. FDA has revised its new drug regulations to accept appropriate data concerning foreign use for prescription products, the petition notes, adding that it would be "anomalous for the agency to accept foreign demonstration of the safety and efficacy in the NDA context while uniformly denying its relevance and use in the OTC context." The German firm pointed out that a review of the ingredient through the OTC monograph process will result in greater public participation than would the NDA process. The firm has not received any reports of adverse reactions to the ingredient during its "longstanding marketing history in West Germany, Sweden, France, Switzerland, Finland, Brazil and Spain," the petition notes. Small-scale clinical efficacy tests conducted in West Germany with 5% and 10% concentrations of PEG-25 PABA demonstrated an SPF range of 2.9 to 5.3; the ingredient's efficacy also was tested by Piz Buin marketer Greiter AG, the petition says. PEG-25 was provisionally listed by the European Economic Community in 1983; the European trade association COLIPA has petitioned the EEC to extend the provisional listing until Dec. 31, 1991 and permit its permanent marketing thereafter, the petition says.