Monograph Criteria Eligibility, Poison Treatment Proposals Lead OTC Agenda
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed rule on eligibility criteria for additional monograph indications and a proposed amendment to the monograph on poison treatment products lead the list of OTC review documents that appear to be furthest along at the agency, according to FDA's "unified agenda," published in the April 26 Federal Register.
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FDA's proposed rule on eligibility criteria for additional monograph indications and a proposed amendment to the monograph on poison treatment products lead the list of OTC review documents that appear to be furthest along at the agency, according to FDA's "unified agenda," published in the April 26 Federal Register. The agenda projects publication of the long-awaited eligibility proposal in May (see chart, p. 11). The proposed rule is expected to revise the agency's definition of what constitutes marketing to a "material extent" and for a "material time" for the purpose of considering new OTC "conditions of use" under a monograph. An advance notice of proposed rulemaking published in October 1996 discussed acceptance of foreign marketing data as part of the process ("The Tan Sheet" Oct. 7, 1996, pp. 1-3). At an industry scientific and regulatory conference last fall, FDA OTC Drug Division Acting Director Debra Bowen, MD, called the monograph eligibility rule the "highest priority for us in the division" ("The Tan Sheet" Nov. 16, 1998, p. 3). Release of the sunscreen final monograph in May was mandated by the FDA Modernization Act. However, industry is seeking a stay of its publication pending establishment of test methods for UVA protection ("The Tan Sheet" April 19, p. 8). Release of final rules on cough/cold antihistamines, cough/cold combinations and cough/cold antitussives all are targeted for June, as is publication of a final rule on cough/cold combination products containing ephedrine. FDA proposed in August 1997 to amend the cough/cold antitussive monograph to require a label warning for diphenhydramine topicals cautioning against use for certain conditions or with other diphenhydramine-containing products, including oral drugs ("The Tan Sheet" Sept. 1, 1998, p. 4). A proposed amendment to the antitussives monograph would expand the required label warning regarding flammability or combustibility of camphor/menthol antitussives ("The Tan Sheet" July 20, 1998, p. 4). FDA proposed in July 1995 to withdraw ephedrine from OTC status in brochodilators and cough/cold combinations because of its use in the illicit manufacture of controlled substances and the potential for misuse and abuse of the OTC products. |