Eyeworld

EW NEWS & OPINION 11 M r. Chairman, Ranking Member Degette, and Members of the Sub- committee, I am Dr. Sean Ianchulev, and I would like to thank you for the opportunity to share my experience with the FDA and the regulatory process and its impact on patient care, innovation, and the development of new technologies. The opinions I share are solely mine and not of the entities I am associated with, and they reflect my experience as a physician, innovator, and developer of new therapeutics and devices. In a way of background, I am a physician, eye surgeon, who uses medical tech- nology and devices to treat and prevent blindness. As an associate clinical professor at the UCSF School of Medicine, I see firsthand the translation of research into pa- tient care. As a developer and inventor of new technologies in the field, I have led innovative treatments through the regulatory process where I have had direct expe- rience with both the drug and device side of the FDA, in addition to experience with the European regulatory authorities. Physicians such as myself feel privileged to be educated, practice, and advance medicine in the U.S. The U.S. has been a leader in cutting-edge innovation tradition- ally and the ophthalmology field is a bright example of that. The most common im- plant today is the intraocular lens with more than 3 million surgeries per year. This is one of the rare times where we virtually cure a chronic degenerative process in medicine. Based on great innovation in the 1980s and 1990s, which along with lead- ership by the FDA and a streamlined regulatory process at the time, we now have cataract surgery helping millions as a safe and effective treatment. Today more than ever we need best-in-class technology in service to our aging population. And while we are rarely able to cure disease, we need to advance treat- ments and provide our patients with responsible but timely access to treatment op- tions when conventional therapies fail. It is unfortunate that patients are starting to seek care from foreign doctors who are now trained and have hands-on experience with technologies we see years later in the U.S. As a physician who not only delivers the standard of care, but also innovates in the ophthalmic field, I have failed a num- ber of times to treat patients with what I think is the best therapeutic approach. In fact, I see patients more and more often take the challenging offshore route in search of interventions that are not available at home with added cost, frustration, and pain. When recently asked by a patient suffering from a degenerative and blind- ing eye disease about a therapy not approved in the U.S. but approved in other de- veloped countries, I was not able to help. The patient ended up traveling to Canada to receive treatment for which he paid out of pocket. But I would like to go beyond the anecdotal experience and ask the bigger ques- tion: What innovative first-in-class therapies are we delivering to patients today? Let's take the field of ophthalmology, which is a good example with its high degree of technical innovation and device utilization. To check the pulse of innovation prior to this hearing I reviewed all the FDA approved PMA devices over the past 5 years. As you are aware, the PMA class III device pathway is the lifeblood of innova- tion and some of the most advanced and complex devices for life-sustaining or vi- sion-sustaining intervention are approved through this process. I reviewed the labels of all 12 such devices approved by the CDRH. At the time of approval, all had been approved not only in the EU and many were registed in as many as 20-40 countries before FDA approval. In addition, some of the devices already had vast clinical expe- rience dwarfing the FDA clinical trial numbers—in some examples more than 100,000 worldwide patients had been treated prior to the FDA approval. In one such illustrative case with a cumulative world experience of more than 60,000 patients, the FDA label only spoke of 300 patients in the registration trials—too few and too late. Avoiding a long discourse on the meaning of this symptomatic state, it is not hard to see that we have failed to deliver best-in-class innovation to patients and cli- nicians in the U.S. More importantly, we now see that the new technologies are not only perfected abroad, but are developed and commercialized to their full extent. Companies now execute not only on small feasibility tests, but implement their main validation studies, clinical research programs, and even product launches abroad, as evidenced by a recent MDVC report. What follows with that is the depar- ture of talent, expertise, and patients. November 2011 Testimony by Sean Ianchulev, M.D., M.P.H. Congressional hearing on the impact of medical device regulation on jobs and patients Ophthalmologist invited to testify at congressional hearing on FDA T he regulatory approval process for new devices and drugs in the U.S. has become increasingly difficult, expensive, and un- predictable. Compared to the regulatory process for new medical technology in Europe, the cost and financial risk as- sociated with FDA approval have risen to untenable levels that are stifling progress and investment in medical innovation. It is hard to quantify the damage to our national economy in terms of lost jobs, global sales, investment, and new potential startup companies. Most frustrating to physicians, however, is the unavailability of so many important treatments and technologies that are available to patients abroad, but not in the U.S. For American cataract surgeons, our premium IOL patients are paying the high- est fees in the world while expecting the best technology, but we lack access to the newest multifocal, toric multifocal, light adjustable, and accommodat- ing IOLs available in Europe. I was impressed by and in full agreement with the recent testimony of Sean Ianchulev, M.D., M.P.H., before the House Energy and Commerce Sub- committee on the FDA's regulatory policies. A graduate of Harvard's Medical School and School of Public Health, Sean completed his ophthalmology and glaucoma training at University of Southern California/Doheny, Los Angeles, and is currently an associate clinical professor at University of California, San Francisco. He is licensed to practice both in the U.S. and the E.U. His creden- tials as an expert in innovation and regulation are unique. Sean is an accom- plished inventor holding several patents for intraoperative biometry, which cover the ORange intraoperative aberrometer (WaveTec Vision, Aliso Viejo, Calif.). He is chief medical officer of Transcend Medical (Menlo Park, Calif.), a glaucoma device startup company, and a partner with the Tullis Health In- vestors venture capital firm (Stanford, Conn.). Finally, he was Genentech's (San Francisco) group director of the Lucentis clinical trials where he headed clinical development and medical affairs of the ophthalmology franchise and was instrumental in the launch and success of Lucentis. For this special edition of EyeWorld devoted to the innovation cycle, I interviewed Sean about the experience of appearing before a congressional subcommittee. I also invited ASCRS immediate past-president R. Doyle Stulting, M.D., to comment on Sean's recent testimony, which we are reprinting for EyeWorld's readers. ASCRS has been actively involved in FDA reform and the device approval process and has been discussing several key issues with FDA officials and Congress. These include the MDUFA reautho- rization, 510(k) premarket review process reform, de novo process simplifi- cation, off-label use, and maintaining regulatory predictability. This continues to be a high-priority issue for ASCRS. In fitting comments made during his House subcommittee's hearing, Chairman Cliff Stearns (R-FL) said that FDA regulations "played a key role in the national decline of medical innovation" and that FDA officials should "bet- ter understand the fact that patient safety and public health are not only jeopardized by approving devices that are unsafe, but also by failing to ap- prove devices that are safe." David F. Chang, M.D., chief medical editor continued on page 12 Chief medical editor's corner of the world

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