Industry balks at melamine guidance
This article was originally published in The Tan Sheet
Executive Summary
A coalition of pharma industry groups, including the Consumer Healthcare Products Association and the Pharmaceutical Research and Manufacturers of America, requests FDA withdraw its final 1guidance on testing for melamine contamination in pharmaceutical products, which the agency issued in August. In a Sept. 9 2letter, the Coalition for the Monitoring of Melamine Adulteration says given the lack of "acute risk" from melamine in their products, FDA should reissue the guidance in draft form with a Q&A document and allow for a comment period. The coalition recommends FDA address supply chain integrity, rather than focus on specific adulterants. Industry also asks FDA to be more flexible about testing methods and eliminate the word "requirements." FDA acknowledged it is not aware of any melamine-contaminated drugs (3"The Tan Sheet" Aug. 10, 2009, In Brief)