Eyeworld

EW NEWS & OPINION 14 there are enough signs and symp- toms in Washington. The question is what is the true problem statement, the root cause, and how do we fix it. I was able to find powerful examples in the ophthalmic field, which has seen landmark innovations such as phaco and IOLs. One can hardly imagine any other technology im- pacting so many people and so effectively—the IOL is the most im- planted device with more than 3 million surgeries. These advance- ments were mainly the product of a streamlined regulatory process of the 80s and the beginning of the 90s. Where are we today? For Congress, I reviewed all ophthalmic devices ap- proved through the PMA process in the past 5 years—a total of 15 ap- proved innovations. Before approval in the U.S., all 15 had been ap- proved in other countries years be- fore, most in as many as 20-40 countries. In fact, several had more than 50,000 treated patients world- wide, and the FDA label spoke of only 300 or so patients from a clini- cal study done years later in the U.S. Does this speak of first-in-class inno- vation? Are our clinicians on the frontline of medical care? Congress is starting to ask the same questions. The FDA is listening as recent initia- tives such as the Innovation Path- way seem to imply. But whether these steps are the right medicine at the right time remains to be seen. Dr. Chang: From your preparatory research, what were your most im- portant suggestions for reform/im- provement of the regulatory process? Dr. Ianchulev: There are many op- portunities to be better and smarter. First, we need alignment on "the de- sired state" and where we strike the balance between innovation and regulation. In my mind, contrary to some of the fear tactics one hears in the press or in Washington, what we want is a more efficient, more streamlined, and more predictable regulatory process. This does not mean lowering our safety bar and letting bad technologies through. It is about focusing on efficiency and operational excellence, something even the government acknowledges is a challenge with high staff turnover and limited resources and expertise. Second, we need to look around and see what practices and strategies have been successful in other countries. Those should be un- derstood and adapted, not rubber- stamped. For example, it is interesting that research shows that while technologies get to patients and clinicians in the E.U. much faster, sometimes by more than half a decade, there is no higher rate of Class I recalls with major safety is- sues. Third, we need clear guidance from Congress in 2012 with specific legal framework so that terms like "least burdensome approval path" are not ignored or misconstrued. If you can make the right regulatory decision 12 months earlier, the im- pact is tremendous. It is not only measured in company burn rate and dollars, but in patient suffering, hope, and trust—not to mention the potential loss in jobs, expertise, and talent this country has worked so hard to cultivate. EW Contact information Ianchulev: tianchul@yahoo.com November 2011 Dr. Chang continued from page 13

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