Will House Republicans’ FDA Plan Help or Hurt Patients?

Oct 25, 2011
Health Care

By Rep. Cathy McMorris Rodgers (R-WA)

Published in National Journal.

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.

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