Editorial: A truly bipartisan push for innovation10/27/11
The Star Tribune
Editorial: A truly bipartisan push for innovation
Updated: October 26, 2011 - 6:34 PM
Minnesota delegation spearheads medical-device reform.
Minnesota's congressional delegation has done something radical in an era when bipartisanship seems extinct by working across the aisle on a sensible set of reforms to streamline the medical-device regulatory process.
The debate over the U.S. Food and Drug Administration's oversight has simmered for years in Minnesota and elsewhere. The industry has long been frustrated by the unpredictability and frequent delays in the approval process for new products. But some consumer-advocacy groups, citing a few high-profile product recalls, argue that the FDA is rushing products through without adequate scrutiny.
The issue came to a head this year, which makes the congressional effort championed by Republican Rep. Erik Paulsen and Democratic Sens. Amy Klobuchar and Al Franken so timely. A PricewaterhouseCoopers report concluded that device-industry jobs are going to countries that have more-efficient regulatory systems. And late this summer, a prestigious scientific panel abdicated the responsibility it had to help the FDA improve a key product-clearance process.
The legislative reforms have been introduced as a bevy of individual bills, a strategy that maximizes the number of lawmakers who can claim credit for this projobs policy fix. The overall effort is remarkable not only for its collaboration, but for its restraint.
Congress isn't proposing a dramatic revamping of the device regulatory system -- which is good, because one wasn't needed. Instead, politicians have done their homework and have come up with important but moderate adjustments to foster innovation without compromising safety.
The reforms leave both the FDA's approval standard and its responsibilities intact. The proposed fixes instead have a pragmatic focus -- easing staff workload and improving their access to outside scientific experts -- to help the agency expeditiously evaluate new products as device technology grows more complex.
There's also a messaging component to the legislation. A measure pushed by Klobuchar in the Senate and Republican Rep. John Shimkus of Illinois in the House basically reaffirms the FDA's existing "least burdensome" requirements. These provisions require the agency to focus only on relevant information during product reviews and to consider reasonable alternatives to avoid delays. The proposal in effect tells the agency that it's been blowing off this responsibility and that it needs to start taking it seriously.
Perhaps the biggest change under consideration is spearheaded by Paulsen, whose Third Congressional District includes many device firms. Paulsen is pushing for more "third-party review" -- having private firms perform some device evaluation, a process used heavily in Europe. The FDA would still review the paperwork and ultimately sign off on new products. But having more outside firms do some of the grunt work in the review process could ease the agency's workload and reduce evaluation time. This proposal needs further airing, but it's worthy of serious consideration.
The FDA deserves credit for working to resolve industry concerns. The congressional proposals build on that work and offer a refreshing reminder that collaboration is still possible on Capitol Hill.
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