FDA move helps calm industry fears about regulatory overhaul.
Star Tribune Editorial
The federal agency overseeing a leading Minnesota industry -- medical device manufacturing -- sent a strong signal Wednesday that the Obama administration is serious about a new presidential promise to cut through business-stifling regulatory red tape.
The medical technology industry, which employs about 27,000 Minnesotans, has long voiced its concerns about a pending regulatory overhaul by the U.S. Food and Drug Administration (FDA).
Firms have been frustrated by the unpredictability of the device-approval process, its expense and the agency's lack of transparency.
In Minnesota, that lengthy process has severely hobbled or killed a number of promising startups.
While many in the industry support clarifying and streamlining the process, there also have been fears that FDA changes would only increase the regulatory burden -- by requiring additional clinical trials for some devices, for example, or requiring others to go through a longer, more detailed approval pathway.
On Tuesday, a Wall Street Journal opinion article by President Obama caught the medical technology industry by surprise.
Deep within an essay calling for a 21st-century regulatory system was a paragraph announcing that the FDA on Wednesday would lay out a "new effort to improve the process for approving medical devices" -- one that will improve patient safety while getting innovative new treatments to market more efficiently.
It's too soon to say whether the new FDA guidelines deliver on that promise. The guidelines deal with what's known as the "510(k) process,'' which is designed for products similar to existing ones and is generally considered a more expedient path to market.
The FDA punted on several controversial issues: creating a new class of devices, establishing companies' postmarket obligations and clarifying the FDA's ability to rescind a device's 510(k) clearance.
But it made sense to wait on those because the FDA previously asked the prestigious Institute of Medicine (IOM) to review its device-approval process and make recommendations. The IOM's report is expected this summer.
Wednesday's FDA move "was an important event. It doesn't tell us answers, but it tells us the process is going forward,'' said Ralph Hall, a professor at the University of Minnesota Law School who specializes in drug and medical device regulation.
Still, the FDA's actions suggest there's substance to Obama's red-tape rhetoric. An agency long thought of as secretive in its decisionmaking clearly outlined its process and timeline for making changes.
Its top officials stressed the importance of potentially life-saving innovation. They acknowledged that regulations have economic impact.
And, they promised to move quickly to address other key industry concerns, such as clarifying confusing terms in regulations and calling in outside scientific experts when needed.
"What we heard in our judgment is a much more balanced approach,'' Hawkins said. "This has been a positive sign of a more constructive FDA. I'm encouraged.''
There's much more work to be done on these regulatory issues, and the devil, as always, will be in the details yet to be worked out.
But the change in direction by this massive federal agency is a step forward.
Officials clearly listened to all stakeholders -- patients, providers and industry. As the process goes forward, it's critical that both the FDA and the IOM continue to work in an open, transparent fashion.
The Obama administration needs to press other agencies to follow the FDA's lead.
Readers: What do you think of the FDA streamlined process? Will this make America more competitive in medical technology development? To be considered for publication as a letter to the editor, write no more than 250 words to firstname.lastname@example.org. Include your name and the city where you live.
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