EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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12 EW NEWS & OPINION Societies continued from page 11 May 2012 "These types of events provide an environment in which private practitioners learn about new prod- ucts, as well as provide a valuable time for discussion of off-label infor- mation among peers," Dr. Stulting said. "A physician can always read the labels, so simply repeating label information is not very informative to them." While the FDA seems to recog- nize the value of off-label uses of drugs and devices, the draft guid- ance makes it clear that the informa- tion should come from the company and not from speakers. "It can be in the best interest of public health for a firm to respond to unsolicited requests for informa- tion about off-label uses of the firm's products that are addressed to a pub- lic forum, as other participants in the forum who offer responses may not provide or have access to infor- mation about the firm's products," the draft guidance said. The comment letter specifically asks that the new restrictions be taken out of the draft guidance. "It focuses on protecting the value of physicians' ongoing educa- tion and the ability of any physician to openly discuss and respond to questions about off-label uses of drugs and devices in an educational public forum with their colleagues, as is the current custom," Dr. Stulting said. EW Contact information Chang: 650-948-9123, dceye@earthlink.net Stulting: 770-255-3330, dstulting@woolfsoneye.com Take Your Practice to the Next Level BY ADDING A HEARING CARE CLINIC Vision and Hearing - Dual Sensory Treatment • Sustainable Business with High Profit Potential Created for Eyecare Professionals by Hearing Professionals Experts in Hearing Care with 240 Locations Nationwide For More Information Call Today! Avada Hearing Care 1-888-982-8232 Partnering Vision & Hearing www.avada.com © 2012 Hearing Healthcare Management, Inc.