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ATTAPULGITE MONOGRAPH DECISION DEFERMENT REQUESTED BY NDMA

This article was originally published in The Tan Sheet

Executive Summary

ATTAPULGITE MONOGRAPH DECISION DEFERMENT REQUESTED BY NDMA in order to give the industry additional time to submit data regarding the effectiveness of the ingredient. "If FDA is sufficiently concerned about the adequacy of the original attapulgite studies," the Nonprescription Drug Manufacturers Association stated in an Aug. 10 letter to FDA, then the "agency should finalize the monograph for all other antidiarrheal products while explicitly deferring final action on attapulgite." In an accompanying memo to FDA, NDMA's Attapulgite Study Group recommended either reopening the administrative record for the submission of additional data or publishing an amendment to the tentative final monograph that would reclassify attapulgite as Category III (data insufficient to permit classification), thereby providing additional time for industry to submit data. The NDMA study group also recommended that the agency use the preamble to the final monograph for OTC antidiarrheal products to explain that "marketing of attapulgite-containing products may continue pending a decision." FDA's Nonprescription Drugs Advisory Committee and Gastrointestinal Drugs Advisory Committee at a joint meeting on April 9 voted 14-1 that the efficacy of attapulgite for treating diarrhea in adults is unproven ("The Tan Sheet" April 12, p. 1). At the same meeting, the advisory committees voted 8-6 that kaolin's effectiveness as an OTC antidiarrheal in adults has been established. NDMA had requested an OTC feedback meeting earlier this summer to discuss the advisory committee's recommendation on attapulgite. However, that meeting was indefinitely postponed ("The Tan Sheet" July 12, In Brief). In the Aug. 10 letter, NDMA Senior VP and Science & Technology Director William Soller, PhD, noted that the industry group would be "in touch with you shortly to schedule a time for a meeting to discuss the NDMA Attapulgite Study Group's research plans and request for deferral of action on attapulgite." The memo asserts that a decision by FDA to place attapulgite in Category II (not safe and effective) in the final monograph would be "manifestly unfair" given the agency's determination in the tentative final monograph published in April 1986 that attapulgite was a Category I (safe and effective) ingredient. "Manufacturers relied on the agency's placement of attapulgite in Category I, and consequently . . . reformulated attapulgite as the active ingredient, to conform to the TFM," the memo from the NDMA task group points out. For example, Upjohn's Kaopectate products were reformulated after the publication of the tentative final monograph in 1986. The TFM placed the product's original active ingredients, kaolin and pectin, in Category III. In response, Upjohn reformulated Kaopectate with attapulgite. To support its contention that FDA should delay a monograph decision on attapulgite, NDMA cited several precedents where FDA deferred final action on specific OTC ingredients to enable the industry to address specific agency concerns. NDMA pointed out that benzoyl peroxide, doxylamine succinate, live yeast cell derivative, yellow mercuric oxide and nighttime sleep-aid combinations are examples where FDA set aside particular ingredients when it issued a final monograph. In addition, NDMA pointed out, FDA allowed these ingredients to remain on the market while new data were submitted to the agency. NDMA asserted that attapulgite "fully accords with this policy and practice." The NDMA task group also questioned the advisory committee's decision on the grounds of "procedural fairness." The association noted that "interested persons" were not notified "that the original effectiveness data for attapulgite would be challenged." NDMA suggested that the initial intent of the advisory committee meeting was to address efficacy questions raised in a "citizen's petition generally assailing the use of antidiarrheal products." NDMA maintained that "manufacturers of OTC antidiarrheal products containing attapulgite were not given adequate notice that the NDAC meeting would resurrect previously resolved "efficacy questions with respect to attapulgite. In addition, the association asserted that the industry "must be given adequate time to respond to allegations made at that meeting."
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