Eyeworld

EW FEATURE 38 human studies. "We understand that we need to make sure that more of the first stages of innovation occur in the U.S.," Dr. Eydelman said. "We always view the United States as being the leader in medical devices, and we want to make sure that it re- mains as such." To that end, Dr. Eydelman said that among other things the agency is working collaboratively with the Association for Research in Vision and Ophthalmology and the Na- tional Eye Institute on improving clinical trials. The CDRH is also working with the American Acad- emy of Ophthalmology in develop- ing and modifying registries for post-market surveillance. Efforts are also underway to bet- ter guide companies through the ap- proval process. "I truly believe that some of the issues are with industry not understanding the steps that it needs to take," Dr. Eydelman said. "Device companies tend to be very different entities from drug compa- nies in that they're usually small or- ganizations that have limited regulatory experience." She pointed out that as these groups come in they are often not clear about the appropriate regulatory steps that they are eligible for. "We are going to be putting pen to paper so to speak and delineating all of the steps to make sure that more of the first- in-human studies are conducted in the United States," she said. Considering the FDA's role Janet Trunzo, executive vice presi- dent, Technology and Regulatory Af- fairs, AdvaMed, Washington, D.C., sees the timeliness issue as emanat- ing from the FDA's own inquiries. "We've seen in the FDA system, es- pecially for 510(k)s, the total time to market has been increasing over the last 4 or 5 years," she said. "From our perspective there is a lack of pre- dictability in the review process, and there are a lot more questions that are being asked during the review of 510(k) submissions." She pointed out that the FDA's data show that the number of times that the agency requests additional information has steadily increased over the last 5 years. "Those requests for additional information stop the review clock and the company has to respond," Ms. Trunzo said. She noted that this is directly propor- tional to the total increase in review time. Brock K. Bakewell, M.D., clini- cal assistant professor of ophthal- mology, University of Utah, Salt Lake City, thinks the FDA is doing a good job protecting the public but presses for expedition in approvals. "Not too many drugs and devices get taken off the market after they're put on, and that's a testament to the fact that the FDA does a pretty good job of monitoring the safety of these drugs and devices before it allows them to be approved," he said. "But I would like to see it better delin- eated up front what's expected." To enhance timeliness he proposed looking at the data for products that have been approved elsewhere. "Why not look at Canada's use of the Toric ICL [STAAR Surgical, Mon- rovia, Calif.] and see what the data is?" he asked. It is a difficult situation for the FDA, said Judy Gordon, president, Clinical Regulatory Consulting Serv- ices, Laguna Beach, Calif. "The FDA is in a very challenging position be- cause there's no reward to it for ap- proving products or moving things along, and when things don't go well it's under terrible criticism," Ms. Gordon said. "It makes the process very challenging." Ms. Trunzo supports some of the new initiatives coming out of the CDRH including a new FDA reviewer training certification program. "We also support issuance of device-spe- cific guidance documents or updat- ing current guidance documents so that companies know what the re- quirements are," she said. "That brings more transparency and pre- dictability into the review process, and that's of course what we're all seeking." Overall, Dr. Eydelman is opti- mistic about the future. "I'm very excited about all of the initiatives that we're currently involved in," she said. "I truly believe that we're improving science and that we're improving the way ophthalmic de- vices are regulated around the world." EW Editors' note: Dr. Bakewell has finan- cial interests with Abbott Medical Optics (AMO, Santa Ana, Calif.). Dr. Eydelman, Ms. Gordon, and Ms. Trunzo have no financial interests related to their comments. Contact information Bakewell: 520-293-6740, eyemanaz@aol.com Chambers: wiley.chambers@fda.hhs.gov Eydelman: malvina.eydelman@fda.hhs.gov Gordon: 949-715-0609, judy@clinregconsulting.com Trunzo: mbrager@advamed.org February 2011 Innovation in ophthalmology November 2011 If I ran the FDA I magine you magically found yourself sitting behind the biggest desk at the FDA. How would you run things? That's the question that EyeWorld presented to several physicians. Richard L. Lindstrom, M.D., adjunct professor emeritus, ophthalmology department, Uni- versity of Minnesota, Minneapolis, and founder, Minnesota Eye Consultants, Minneapolis, sees safety as the FDA's primary role. He be- lieves that determining efficacy should fall to practitioners instead. "If products had reasonable safety with complication rates that were inside a standard acceptable range, then let things sort out in regard to com- mercial success and comparative efficacy in clinical practice," he said. His "administration" would return to interpreting longstanding laws as more favorable to industry. He would, however, be a stickler on fol- lowing the FDA's guidelines on the length of the review process to give a better idea of a timeline for product approval. He would also take a strong lobbying stance. "I would be out there fighting for more money for my agency so that I could have enough people to do my reviews in a timely fashion," he said. William J. Link, Ph.D., managing director, Versant Ventures, Menlo Park, Calif., would also focus primarily on safety akin to the CE mark process. "They primarily do a safety screen and let the marketplace and the companies have the responsibility of evaluating and communicating the efficacy," he said. "That balance seems to be working well in Europe." He would adjust safety standards based on the condition or risk. "If it's a really challenging disease with patients that have a very low proba- bility of survival then the safety bar might be different than if it's an aes- thetic procedure that otherwise healthy patients are choosing to have," Dr. Link said. Likewise, Richard A. Lewis, M.D., Sacramento, Calif., would allow the marketplace to dictate whether a product proven safe is successful. He would allow something like the Glaukos device (Laguna Hills, Calif.), which has been proven safe, to make its case for efficacy after approval. Dr. Lewis would put in place defined approval deadlines. "I would like them to raise the cost to the companies to do this within a reason- able time but then ensure that they're going to guarantee within a timely manner," he said. Otherwise he worries that companies will begin to take their products elsewhere to do studies. "It's going to shift innova- tion elsewhere and venture capital money is going to flow with it," he said. Reay H. Brown, M.D., Atlanta, sees handling efficacy as a lesser role for the FDA. He would set the safety bar based on the condition being treated. "If it's an elective procedure such as refractive surgery I could understand that it needs to be higher," he said. "But it's a different story for glaucoma, which is a blinding, incurable disease." He would also test devices for different diseases separately. To speed approval, he would reduce the length of study time and re- duce the number of patients to be included. Dr. Brown would consider privatizing the approval process to add new incentives. He pointed to Glaukos, which has been stalled for a while. "That would not happen in the private world—time just doesn't move that slowly," he said. In the end, Dr. Brown would also put his own "FDA position" peri- odically up for grabs. "The only way we can keep everyone on track, in- cluding me, is with the competing interests that are out there," he said. Editors' note: Dr. Brown has financial interests with Alcon (Fort Worth, Texas) and Ivantis (Irvine, Calif.). Dr. Lewis has financial interests with Alcon, Aller- gan (Irvine, Calif.), Glaukos, iScience (Menlo Park, Calif.), Ivantis, and Merck (Whitehouse Station, N.J.). Dr. Lindstrom has financial interests with Abbott Medical Optics (Santa Ana, Calif.), Alcon, and Bausch & Lomb (Rochester, N.Y.). Contact information Brown: 404-237-4368, reaymary@comcast.net Lewis: 916-649-1515, rlewiseyemd@yahoo.com Lindstrom: 952-567-6051, rllindstrom@mneye.com Link: 949-729-4500, bill@versantventures.com Walking continued from page 37

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