Joe Pitts: “The United States is in danger of losing its status as the world leader in medical device innovation. Multiple studies…”

“The United States is in danger of losing its status as the world leader in medical device innovation. Multiple studies have shown that regulatory uncertainty and a delay and inefficiency at the Food and Drug Administration are damaging this critical industry. Shorter, more predictable and more transparent approval processes in Europe have led many device companies to seek to market their products in Europe before submitting them to the FDA. This hurts American patients who, on average, have access to innovative medical devices 2 years later than patients in European countries, and, in some cases, never have access to these devices. And does a longer, more uncertain regulatory process by FDA result in making American patients any safer? The answer is no. According to recent studies, medical devices marketed through the shorter and more transparent European regulatory processes are statistically as safe as FDA-cleared and -approved devices and have comparable patient outcomes. Regulatory uncertainty also hurts American competitiveness as innovative device companies are moving jobs overseas. And these are good jobs. Nationally, jobs in medical technology pay almost 40 percent higher compared to the national earnings average.”