In Brief: Furness in new CDER role; Oxytrol for Women at retail; advisories on drug-tainted sex enhancers; senators want energy drink restrictions

After six years leading FDA’s Division of Nonprescription Regulation Development, with oversight of the OTC monograph system, Scott Furness transitions within the agency to be acting deputy director for review and operations in the Office of New Drug Quality Assessment, effective Sept. 23. Debbie Lumpkins, previously deputy director of DNRD under Furness, is now acting division director. An FDA spokeswoman said the transition will not affect ongoing monograph activities, and Furness “plans to continue working in his new role to lead the modernization of the OTC monograph system with respect to quality, biopharmaceutics and manufacturing process development.” Furness had publicly expressed frustration with the slow process of amending monographs, but recently said DNRD is making progress in reviewing long-delayed time and extent applications for OTC ingredients ([A#05130513003]).

Merck & Co. Inc.’s first-in-class OTC for overactive bladder, Oxytrol for Women, is now available for purchase, the company announced Sept. 25. The transdermal oxybutynin patches are priced on...