opinion
Arne Carlson: Rule changes threaten a key industry
- Article by: ARNE CARLSON
- Updated: May 17, 2010 - 6:02 PM
The FDA is making it difficult for medical device makers to innovate.
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In 1957, Medtronic founder Earl Bakken developed the first wearable external pacemaker; many say he created an industry. But the successful commercialization of the pacemaker required a partnership among physicians, patients, the University of Minnesota, engineers, business leaders, investors and regulators. Because these key players worked together, Minnesota became a major center for the global device industry, producing medical innovations that have improved and saved millions of lives.
But today, one team is changing its rules to the detriment of medical innovation: federal regulators. Current and planned policy changes by the Food and Drug Administration are increasing the time, cost and risk associated with developing new medical technology, which means decreased investor capital and R&D spending at larger device companies. It's this capital that fuels innovation and drives our economic growth.
Device companies and venture capitalists are not the only ones affected by the FDA's actions. All Minnesotans face potential consequences as one of the state's leading industries erodes. Minnesota boasts more than 400 medical device companies, employing more than 30,000 people. But more important, each device industry job creates two additional employment opportunities in the state. Minnesota currently is not growing jobs at an acceptable pace and cannot afford to let the FDA further derail its major economic engine.
The FDA is charged with making safe and effective devices available to consumers -- this is the first part of its mission. Obviously, safety is critical, and the FDA must hold device makers accountable to acceptable safety standards. But no one can guarantee a perfectly safe device. There is always risk associated with medical procedures. The FDA cannot overreact to a small minority of issues and risk the demise of an entire industry. That cost is too great.
The FDA and the medical device industry have successfully worked together for many years to ensure that medical devices receive the appropriate level of scrutiny to benefit patients and advance medical technology -- it's a team effort. Focusing too much on the risks of new technology and not enough on innovation and patient benefits is shortsighted. Patients and the economy both lose.
On May 18, Minnesota will welcome Dr. Jeff Shuren, the FDA's director of the branch that regulates medical devices, for a town hall meeting to discuss potential changes. I applaud Shuren's decision to engage Minnesota's highly regarded device community in a dialogue about current and future policies.
We welcome change. But the changes should accelerate innovation, not hamstring it. Medical device companies, physicians and venture capitalists are investing time and money on new devices, agreeing to clinical study rules the agency outlines at the start. But in too many recent cases, the FDA has delayed its feedback to the companies, then determined in the end that the company needs to meet new milestones before the agency will consider clearing the device. That isn't right.
Imagine the University of Minnesota's offense closing in on the goal line against Michigan only to have the ref decide to return the ball to midfield. Faced with such arbitrary decisions, the coach wouldn't know whether to punt or drive. We can't put our medical device CEOs and their investors in that position -- they need clear direction from the FDA in order to effectively run their teams and manage their resources.
Delays such as these, and uncertainty in the FDA's approval processes, have led numerous companies with innovative technologies to conduct trials and pursue approval and commercialization in Europe first. This not only threatens the economic health of Minnesota, but also deprives us all of these therapies.
The United States is the world's only net exporter of medical devices, with a $5.4 billion trade surplus. This is significant considering that since the mid-1980s the United States has had a growing deficit in tradable goods, especially with China and Japan. And medical devices aren't children's toys. They are high-value, specialized products that are developed by doctors and scientists, manufactured by engineers, tested by clinical researchers and marketed by MBAs.
The FDA must reinstate a culture of balancing patient risk and benefit to find ways to accelerate the innovation process and to halt this trend of slowing down or delaying device reviews. The agency must honor its existing agreements with device companies and change the rules only if new science obsoletes an ongoing trial or if there is a proven new safety risk.
Finally, FDA staff imposing regulations cannot be biased against industry, and must possess appropriate professional qualifications and experience levels to sufficiently evaluate the safety and effectiveness of medical devices. In several high-profile cases, lower-level FDA staffers have inappropriately derailed device approvals. Imagine Joe Mauer's reaction if Little League refs were calling plays at a Twins game.
We must return to a more collaborative partnership among entrepreneurs, doctors, business leaders, regulators and venture capitalists if Minnesota and the United States are to remain leaders in the global medical device industry. Are we willing to forfeit this game because the FDA isn't remembering the second part of its mission -- to promote innovation in the medical device industry? This is one we're not willing to lose.
Arne Carlson is a former governor of Minnesota.
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