Eyeworld

EW FEATURE 37 Balancing and appreciating a strong safety record amid calls for new innovation F or the FDA, it can be a high-wire act balancing safety and efficacy of new products on the one hand and innovation on the other. While there is praise from both consumer groups and industry organizations for the FDA's efforts to maintain safety, some have voiced concerns that this may at times be at the expense of patient access to the latest innovative technology. It should be noted that the FDA is in the process of delineating new meas- ures to help move along clinical in- vestigations and approvals for devices. No one surpasses the FDA when it comes to device safety, according to Malvina B. Eydelman, M.D., di- rector, Division of Ophthalmic and ENT Devices, Center for Devices and Radiological Health, FDA, Washing- ton, D.C. "I truly believe that the FDA's assessment represents the most comprehensive approach and is viewed by many even internation- ally as the gold standard," she said. "I am aware of many instances where ophthalmic devices have made it to European markets prior to getting to the U.S. market and have been removed due to safety issues while still being investigated in the United States." Wiley A. Chambers, M.D., deputy division director, Division of Transplant and Ophthalmology Products, FDA, likewise sees the agency's policies with regard to drugs as offering an important seal of approval. "I think that the goal of FDA approval is to provide confi- dence to patients and physicians that the drug that they'll receive is what it says it is and does what it says it does," he said. As far as drug approval speed, Dr. Chambers emphasized that in the area of ophthalmology, the U.S. remains the leader. "If you look at ophthalmic drug approvals as far as any new molecular entities or new types of products, you will see the approval first in the U.S. before you see it in Europe on a fairly uniform basis," he said. February 2011 November 2011 Innovation in ophthalmology by Maxine Lipner Senior EyeWorld Contributing Editor Walking theFDA tightrope AT A GLANCE • The FDA is considered the gold safety standard • Patient access to the latest devices concerns some • A new FDA device initiative looks to improve the approval process continued on page 38 At the Office of Device Evalua- tion, which is responsible for device premarket review, Dr. Eydelman stressed that the goal is timely as- sessment of safety and efficacy of novel devices. "We try to have a consistent, predictable, and trans- parent process, especially for the novel devices," she said. "We always use benefit-risk assessment to help guide our decision-making." However, there has been in- creasing concern that other drug and device clearance pathways, such as those of the European Union, Canada, and Japan, are producing innovative products and technolo- gies more rapidly than the Premar- ket Approval or 510(k) approach for high-risk devices and that the result may be that some U.S. patients are missing out on the most innovative care. A No- vember 2010 study led by Josh Makower of Stanford University showed that on aver- age U.S. citizens wait 2 years longer than those in other countries for access to innovative devices and in some cases up to 6 years longer. New initiatives The Center for Devices and Radio- logical Health (CDRH) has been looking internally to see if there is anything it can do to improve its ef- forts. "We believe to foster innova- tion we need to provide patients with timely access to safe and effec- tive devices," Dr. Eydelman said. "The CDRH is working to maintain the U.S. medical device leadership position by addressing problems with devices that are currently on the market, by increasing the pre- dictability, consistency, and transparency of our pre- market review pro- grams, and by proactively facilitating the develop- ment of breakthrough devices through the innovation initiative." She emphasized that they are in the midst of streamlining their processes to encourage more first-in-

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