Eyeworld

by Matt Young EyeWorld Contributing Editor Observing regulatory environments from West to East There's no easy place for approval H ere's a reality check on regulatory environments in the United States, Eu- rope, and Asia impacting ophthalmology: Regula- tions are similar in some ways, dis- tinct in others, and there may be no "easy" place for device or medica- tion approval. That's according to ophthalmol- ogists and industry observers in each of these regions. The U.S. Food and Drug Admin- istration—deservedly or not— has been defending its reputation against those that say it has become too sluggish in drug and device ap- provals. Europe, meanwhile, is known for being more easygoing on approvals, but the region is com- plex, according to one ophthalmolo- gist there. Although the FDA considers itself to be the "gold stan- dard" throughout the world—in the words of commissioner Margaret A. Hamburg—China has its own in- creasingly rigid safety and efficacy agenda and may be the toughest place to get regulatory approval today. In the West Richard L. Lindstrom, M.D., ad- junct professor emeritus, ophthal- mology department, University of Minnesota, Minneapolis, and founder, Minnesota Eye Consult- ants, Minneapolis, has been an out- spoken critic of the U.S. FDA's impact on innovation in ophthal- mology, and he makes some inter- esting points. "My belief and personal opinion is that the FDA regulatory barrier has become a little too significant in the United States," he told EyeWorld. "That is discouraging innovation and investment in innovation. The timeline to approval … has in- creased over the past decade. The costs have increased over the past decade. This is not in the best inter- est of our country." In ophthalmology, Dr. Lindstrom cited the FDA's impact on corneal collagen crosslinking, a new treatment used for keratoconus pa- tients. "Every month patients have to travel to Canada for collagen crosslinking," Dr. Lindstrom said. "We're still slugging our way through the FDA process here [with crosslinking]. It is disappointing since this is something that seems to have high safety and efficacy." In fact, that may be changing to some extent soon. Dr. Lindstrom ac- knowledged that in September, VibeX (Avedro Inc., Waltham, Mass.) was granted an orphan drug desig- nation by the FDA for use with its KXL System (UVA irradiation), a crosslinking method. The orphan drug designation is granted by the FDA to promote the development of new therapies for rare diseases and disorders. But Dr. Lindstrom said the FDA needs to do more. "The FDA has come out and said it is trying to modify its approach to support innovation," Dr. Lindstrom said. "It is taking some of its re- sources to fast track areas of innova- tion." In an August opinion piece in The Wall Street Journal, Commis- sioner Hamburg defended the Ad- ministration's record on regulatory approvals. "One prevailing misconception is that the FDA lags behind Europe in approving medical products," she wrote. "The truth is that the FDA consistently approves the vast ma- jority of priority drugs and medical devices as fast as, or faster than, our European counterparts. Of the 35 new cancer drugs approved either by the FDA or the European Medicines Agency (EMA) from October 2003 to December 2010, the FDA approved 32—in an average time per drug of 261 days. The EMA approved only 26 of these same 35 products, in an average time of 373 days." That said, she also acknowl- edged the FDA bears "some responsi- bility for the criticism we receive" and said the Administration is "ac- tively taking steps to improve the clarity, consistency, and predictabil- ity of our regulatory systems." Meanwhile, Dr. Lindstrom said he likes the European regulatory sys- tem. "It evaluates safety and de-em- phasizes the evaluation of comparative efficacy," Dr. Lindstrom said. EW International 48 November 2011 Safety remains the key concern among patients and physicians alike. Efficacy is important as well but only in the context of our prime directive, "Above all, do no harm." But what does it mean for a device to be "safe"? What burden of proof must be met? The global standards for safety are tightening, and increasingly clinical tri- als are run internationally. Many Americans feel that the FDA places unrealistic restric- tions on the development of new technol- ogy. It has been over 3 years since a new ophthalmic device, which has been through a phase III trial, has been granted approval and made available for use in the U.S. Clearly this has tried the patience of American ophthalmologists. As we look critically at what is required in other coun- tries, however, many of the same issues must be addressed and the regulatory dif- ferences for product approval may be less than we think. One thing is certain: New technology will continue to be developed. How long it takes to make this available for our patients remains a source of frustration. John Vukich, M.D., international editor International editor's corner of the world

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