DEC 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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30 EW FEATURE February 2011 ahead December 2012 Innovation: A look Innovative ideas abound by Michelle Dalton EyeWorld Contributing Writer The current U.S. regulatory environment has produced some novel ideas on how to foster innovation O phthalmology may be one of the more innovative specialties within medicine���just look at the advances in cataract, IOL technologies, and refractive surgery that have been introduced in the past 5 years. The relationship between industry and physicians is ���as important today as it���s ever been,��� said Richard L. Lindstrom, M.D., founder, Minnesota Eye Consultants, Minneapolis. But a much lengthier regulatory process translates to some innovators moving outside the U.S. to develop their ideas, said George O. Waring IV, M.D., assistant professor of ophthalmology, director of refractive surgery, Storm Eye Institute, and medical director, Magill Vision Center, Medical University of South Carolina, Charleston. Companies can work in a ���parallel fashion outside the U.S. where regulatory approval comes much faster, in both approving clinical trials and commercial launches,��� he said. The regulators��� role Regulatory oversight in the U.S. ���has become onerous, nearly impossible to get anything approved���drug or device,��� said John A. Hovanesian, M.D., clinical instructor, Jules Stein Eye Institute, Los Angeles. The FDA is beginning to realize ���the danger in that, but also the benefit of proving the cost effectiveness of a new treatment,��� Dr. Hovanesian added. ���Physicians have to be at the forefront for pushing innovation that makes sense,��� and that does not necessarily include a drug that has a lower concentration or different preservative, he said. The U.S. currently has a ���much more interventionist federal and state government where the regulators are ascending and the libertarians and free market capitalists are descending,��� Dr. Lindstrom said. ���Industry is at times being severely penalized for what many of us would consider relatively small transgressions���for example being fined $1 billion for teaching doctors how to use products in a way that���s effective but not currently ���on label.������ The situation is likely ���going to get worse before thing get better,��� Dr. Hovanesian said. ���The FDA has raised the bar so high on approvals��� that it has, in essence, prevented some companies from seeking U.S. approval for their wares. ���The U.S. does not necessarily have access to the most advanced technology���not in IOLs or lasers,��� Dr. Waring said, citing companies like Schwind (Kleinostheim, Germany), which does not market its refractive lasers in the U.S. due to the prohibitive regulatory climate. The physician���s role AT A GLANCE ��� The relationship between industry and ophthalmology is as vital today as it ever was ��� The current regulatory environment in the U.S. is much lengthier ��� Education events should continue to shift from product-specific information to disease-specific updates ��� So-called ���microincubators��� are gaining prominence as a way to develop ideas without restraint Physicians in general ���are a bit of a target right now,��� Dr. Lindstrom said. ���Our healthcare system is in transition and struggling and some are looking for a scapegoat, so it���s easy for some to blame ���greedy doctors��� and companies for what is really a systems failure.��� Dr. Lindstrom wholeheartedly endorses transparency (and not just because Minnesota is one of three states���Vermont and Massachusetts are the other two���where the Sunshine Act is a state law), displaying his consulting relationships on his website and in patient literature. ���Patients have seen my consulting as a positive,��� he said. ���It���s not a bad thing. We want our patients to know we���re good enough to be hired

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