This response comes from Rep. Cathy McMorris Rodgers, R-Wash.

Last month, I hosted the first “Jobs and Innovation Forum” on Capitol Hill with a special focus on medical device innovators, how the regulatory process impedes innovators, which ultimately hurts patients, and how to improve that process. The job creators who participated in our forum had a simple yet powerful message: While America has led the medical technology industry for decades, our leadership is being threatened by the Food and Drug Administration’s unpredictable, inconsistent and inefficient regulation of medical devices. To maintain our leadership, they want Congress to charge the FDA with improving the regulatory climate. Should the FDA do that, it would spur innovation in a high-tech, high-paying field, expedite approval of life-saving and life-improving treatments, bolster America’s competitiveness, and create much-needed jobs.

To get a better picture of the status quo, consider that one lifelong developer of medical technologies - an innovator who has created 10 life-saving and life-improving devices that have resulted in tens of thousands of jobs and billions of dollars in U.S. exports - told our Committee that the FDA’s environment and level of cooperativeness is the worst he’s seen in more than 40 years. According to this developer, if the current FDA regulations had been in place over the past few decades, he would not have been able to contribute to his field in the way that he has.

Even though the FDA’s device program has seen an increase in funding, applicants continue to complain about a process plagued by unclear guidelines, high turnover rates on the review division staff, impractical clinical trial designs and changing “goal posts.”

These challenges can have devastating ramifications for sick patients. When faced with a medical condition that could turn degenerative or fatal, these patients were frustrated to learn that life-altering, or even life-saving, treatments were unavailable in the U.S., but available abroad. That is unacceptable.

To help America’s job creators, bolster America’s health care system, and in many cases, save lives, Republicans on the House Energy and Commerce Committee recently introduced 10 bills to reform the FDA and improve the regulatory climate in the medical technology industry.

One of the bills is the Keeping America Competitive through Harmonization Act. I introduced this bill with Rep. Leonard Lance (R-NJ) and six other Members of the Committee to streamline the regulatory process for new medical devices. Specifically, it will require FDA, to the maximum extent feasible, to enter into agreements with Tier One countries, like Australia, Canada, Israel and those of the European Union, on methods and approaches to harmonizing regulatory requirements for premarket review, inspections and common international labels. According to the job creators I met at last month’s forum, harmonizing FDA requirements with those of foreign regulators would be a smart, common-sense reform to keep America the world capital of medical innovation.

Congress has a duty to protect not only American jobs, but also the patients who require access to necessary treatments. While we appreciating the fine line the FDA must walk to maintain safety without blocking access to innovation, it’s time for both parties to work together and ensure the FDA has a better review process to support patients and innovators and our economy.

Rep. Cathy McMorris Rodgers (R-WA), Vice Chair of the House Republican Conference, is a member of the House Energy and Commerce Committee.

This response comes from Janet Trunzo, executive vice president of regulatory affairs at AdvaMed:

America’s medical device and diagnostics companies are engines of innovation -- developing life-changing, life-enhancing technologies and, in the process, creating nearly 2 million U.S. jobs. In order to improve patient access to these technologies and address some of the critical issues impeding our industry’s global competitiveness, the Energy and Commerce committee, under Chairman Upton’s leadership, has put forth the Saving American Jobs and Saving American Patients legislative package.

The package reflects the committee’s extensive work in examining the need for reform through hearings and debate. We believe the effort is an excellent starting point in a legislative discussion to address several important issues critical to maintaining our global leadership and competitiveness.

In addition, we are continuing to work collaboratively with the FDA to make improvements in the device review process, which are being discussed in the ongoing and productive negotiations related to the renewal of the ‘Medical Device User Fee Act.’

As the legislative process moves forward, we look forward to working with the committee, members of Congress on both sides of the aisle, and with the FDA to ensure patients have timely access to safe and effective products.

It is critical that our processes for evaluating new and emerging technologies are as innovative as the technologies themselves. This is no small task, but it is necessary to ensure that the Americans have access to medical care based on the most current science. We must determine the appropriate balance between risk and speed-to-market.

Clinical trials remain the gold standard for science-based evidence development. To qualify for clinical trials, patients must meet certain ideal criteria, facilities and physicians are hand-selected for participation, and the evidence is closely reviewed. Clinical trials simply cannot fully predict all potential outcomes in the real world. This is where a fully developed post-market surveillance system can help.

It is essential that we continue to gather data on a product to observe usage and effects in the real world. By doing so, we learn more about how to best treat our patients and this is where registries make a significant impact. The American College of Cardiology’s National Cardiovascular Data Registry tracks physician-based data on various cardiovascular procedures, including cardiac catheterization, implantation of internal cardiac defibrillators, heart attack and other essential cardiac care. The Society of Thoracic Surgeons has similar capabilities and other specialties are moving in this direction.

The primary purpose of such high-tech registries is improvement of patient care by improving physician performance. Data can also be used to locate safety signals. Registries have detected problems with medical devices, leading to removal from the market. These new registry surveillance and safety systems can track all patients who receive new or experimental devices and drugs much less expensively than older style clinical trials that track a smaller cohort of patients.

The FDA can now apply these tools to better track patient safety and to bring new clinical innovations to market with greater confidence. This is a way to provide the public with access to innovative technologies while better managing potential safety risks and concerns about effectiveness – two primary components of the FDA’s mission.