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EW NEWS & OPINION 13 yet Congress prioritized this topic in the heat of the political debate in Washington. In fact, that same day the clock was running out for the debt-ceiling decision. I think we have reached a critical mass where ACBB Surgery STOP DRY EYE FAST! A SURGICAL SYSTEM THAT WORKS. 3360 Scherer Drive, Suite B, St. Petersburg, FL 33716 7HO)D[ (PDLO,QIR#5KHLQ0HGLFDOFRP:HEVLWHZZZ5KHLQ0HGLFDOFRP 'HYHORSHG,Q&RRUGLQDWLRQ:LWK6WHYHQ/0DVNLQ0' 3&786,QWUDGXFWDO0HLERPLDQ*ODQG3URELQJ5HOLHYHV6\PSWRPV 2I2EVWUXFWLYH0HLERPLDQ*ODQG'\VIXQFWLRQ 0DVNLQ6WHYHQ/&RUQHD2FWREHU 6W\OL]HG(\H5KHLQ0HGLFDO Animation 1317 Rev.A "I went down to Florida to observe Dr. Maskin do several procedures and then went back to Tennessee to do my own! I have done MGP on 6 patients now. All of them are better, and patients state improvement was almost immediate. Patients admit to between a 60% and 100% improvement in their symptoms. I'm ready to do more cases!" Daniel K. Bregman, MD Nashville, TN Cornea Blockage Meibomian Gland Interior Probe The Problem Is Simple: An Occluded Meibomian Gland. Pop Through Gland Blockages With A Maskin ® Probe! 11:12 AM November 2011 visibility the regulatory process has gained in Washington. I think it is an opportunity for us as clinicians, at this critical time when the Pre- scription Drug User Fee Act (PDUFA) is heading for re-authorization in 2012, to inform Congress about what we think is in the best interest of patients and the public. We clini- cians feel the consequences first- hand. Although the FDA does not regulate the practice of medicine, we cannot feel "immune" to the process of innovation today. By limiting or delaying access to new technologies, physicians are precluded from pro- viding the best care to their patients. Dr. Chang: Did the Energy and Com- merce committee leadership under- stand the problems that you and the other experts outlined? What was your sense of their reaction and commitment? Dr. Ianchulev: I think there is intent and willingness to understand where we are heading on a global perspec- tive. Today, there are so many ur- gent and important issues to tackle, continued on page 14 by Nancey McCann ASCRS Director of Government Relations O n October 13, 2011, Senators Amy Klobuchar (D-MN), Richard Burr (R-NC), and 
Michael Bennet (D-CO) introduced S. 1700, the "Medical Device Regulatory Improvement Act," to reduce the regula- tory burdens that unnecessarily delay the approval of new medical devices. The legislation would help streamline the FDA's regulation of med- ical devices without compromising consumer safety. The legislation would reduce some of the regulatory authority of the FDA's Center for Devices and Radiological Health, ease conflict-of-interest rules, and require agency offi- cials to contract with an outside reviewer to evaluate the work of the Center and its impact on medical device innovation. Specifically, the legislation would require FDA officials to "use all reason- able mechanisms to lessen review times" for products, and prohibit FDA offi- cials from requesting information "unrelated or irrelevant to a demonstration of reasonable assurance of device safety and effectiveness." It also would encourage FDA officials to consider ways to evaluate the safety and effec- tiveness of a device "in order to reduce the time, effort, and cost" for the in- dustry. The bill encourages FDA officials to allow less time-consuming and cheaper approaches than randomized clinical trials. Package of 10 FDA reform bills introduced in the House by bipartisan members of the Energy and Commerce Committee and Congressman Erik Paulsen (R-MN) O n the same day that bipartisan legislation was introduced in the Senate to address the FDA approval process for medical devices, members of the House Energy and Commerce Committee and Congressman Erik Paulsen, vice chair of the Medical Technology Caucus, introduced a comprehensive package of 10 bipartisan reform meas- ures to improve the predictability, consistency, and transparency of the FDA's medical device review and approval process. After hearing from patients, inventors, investors, and employers through various hearings, the Committee members noted that the FDA's unpredictable, inconsistent, and non-transpar- ent handling of the review process has threatened the medical device leader- ship of the United States and has negatively impacted American jobs, innovation, and patients. Although not a member of the Energy and Commerce Committee, Congressman Paulsen has worked closely with the committee members on this initiative. Bipartisan legislation introduced in the Senate and House to address the FDA approval process for medical devices

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