Eyeworld Daily News

EW SHOW DAILY 34 Monday, April 20, 2015 submitted, the phase 3 trial failed, or the quality of the product cannot be assured (meaning that the facility making the product is not in com- pliance with current good manufac- turing practices, or the product is not chemically stable for the intend- ed shelf life). There are some new programs, he said, to specifically consider pediatric development and expedited programs for serious con- ditions. Serious conditions in oph- thalmology may include macular degeneration, diabetic retinopathy, and retinitis pigmentosa, among others. Different considerations and requirements may apply for drugs that need to be fast tracked for a serious disease or condition and for breakthrough therapy. Finally, Dr. Eydelman highlight- ed some of the recent action by the FDA and what is being done to get clinical trials back to the U.S. and to get patients in the U.S. quicker access to new technologies. The initial clinical testing of some novel devices has moved to non-U.S. sites, she said, and some devices are being developed exclu- sively for non-U.S. markets. There are a number of potential conse- quences of this, including concerns regarding applicability of study findings to the U.S. population, the lack of prior U.S. experience being associated with longer total time to market, a palpable time lag in the availability of some beneficial medical devices for U.S. patients, and human costs associated with delaying access to new technology. The Center for Devices and Radio- logical Health has a vision to ensure that patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world, Dr. Eydelman said. She then shared some of the re- cent efforts and successes in moving this vision forward. FDA workshops on MIGS and glaucoma therapy and on new IOL technology were suc- cessful, she said. Efforts in guidance and expanding collaboration and a network of experts will help with this. EW by Ellen Stodola EyeWorld Staff Writer regulate them is necessary, Mr. Baum said. "Compounded drugs have an important role in our healthcare economy," he said. Their use is widespread in ophthalmology, and current good manufacturing prac- tices in compounding can increase innovation, increase the choices of MDs, decrease costs to payers, and decrease drug shortages. Mr. Leiter highlighted com- pounding facilities in general and focused on his specific compound- ing facility in San Jose, where he said their principle is "quality without compromise." The whole industry is fragmented and in flux, he said. There are hundreds of inde- pendent compounding pharmacies and most operate on a small scale in local communities. There are a number of regulatory and other factors that drive major change, including consolidation and high- er standards driving higher costs. Many pharmacies are closing down or consolidating, Mr. Leiter said, and many facilities can't afford to operate anymore. He said that the 2 big questions that those who get drugs from a compounding compa- ny should be asking are: Do you test all of your products? How big is the sampling size? Dr. Chambers stressed the specifics of what is regulated under the Food, Drug, and Cosmetic Act, which includes food, drugs, devices, and cosmetics. He also highlighted the distinction between the defi- nition of what can be a drug and what can be a device. Under the act, drugs, biologics, and devices all re- quire pre-market clearance, he said. The act has been amended a number of times, he said. As amended, it prohibits inter- state transportation of unapproved new drugs, requires substantial evidence of safety and efficacy as the basis of approval of new drugs, and permits the FDA to grant exemp- tions from the act to study new drug products. Safety and efficacy are 2 key factors for approval of products. Dr. Chambers shared some common reasons that a product may not be approved, with the top reasons being that the application was never Eydelman, MD, director of the Di- vision of Ophthalmic and Ear, Nose & Throat Devices with the FDA, spoke on improvements to the FDA drug and device approval process. Natalie Afshari, MD, chairman of the ASCRS FDA Committee, served as moderator of the session. Mr. Baum spoke about what is currently happening with drug com- pounding, why these facilities and products are valuable, and specifi- cally what Imprimis is doing. Most cataract surgeons continue to access safe compounded products, he said. In order to realize the promise of safe compounded drugs, a good, pro- ductive relationship between com- pounding pharmacies and those that T his year's symposium spon- sored by the ASCRS Food and Drug Administration (FDA) Committee focused on drug compounding and its impact on ophthalmology and improvements in the FDA drug and device approval process. Charles Leiter, PharmD, CEO and president of Leiter's Compound- ing Pharmacy, San Jose, Calif., and Mark L. Baum, CEO of Imprimis Pharmaceuticals, San Diego, spoke on the drug compounding topic. Wiley Chambers II, MD, deputy di- rector of the Division of Transplant and Ophthalmology Products of the Center for Drug Evaluation and Research with the FDA, and Malvina ASCRS Symposia FDA symposium focuses on drug compounding and improved drug and device approval process Dr. Chambers highlights the importance of safety and efficacy in product approval.

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