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FDA PSE concerns

This article was originally published in The Tan Sheet

Executive Summary

In light of the recent passage of the Combat Methamphetamine Act, "the one thing that we have some concerns about is that industry is just going to sort of blow [pseudoephedrine] away and not pay any attention or have any interest in marketing it," according to Charles Ganley, MD, director of FDA's Office of Nonprescription Products. "I think that would be a downside for the consumer," he said while speaking at the Consumer Healthcare Products Association's recent Regulatory & Scientific Conference. "I know there's been a shift to try to substitute phenylephrine and have that product available OTC, but I think we ought to see how this can work out on this behind-the-counter type status and see if that is a process that could work. So I would hope you would not dismiss pseudoephedrine in the future," Ganley said. The legislation was passed in March as an amendment to the Patriot Act Reauthorization. The bill places sales limits on products containing the ingredient, and will require behind-the-counter sale of all pseudoephedrine products in September...

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