WASHINGTON - A new bill introduced by DFL Sen. Amy Klobuchar seeks to speed the Food and Drug Administration approval process for medical devices.
Klobuchar's bill, introduced jointly with fellow Democrat Michael Bennet of Colorado and Republican Richard Burr of North Carolina, comes as the time it takes to approve new devices has climbed 43 percent in the last decade. At the same time, the medical device industry has come under increased scrutiny due to a series of recalls and studies that call into question the safety of some devices.
Among its many components is a provision to change the FDA's conflict of interest rules regarding outside experts who sit on FDA advisory committees. Klobuchar says the agency has had difficulty recruiting experts to serve on those panels because the current rules are burdensome, a key contributor to the slowdown in the approval process. The bill would apply the same conflict of interest standards that exist across the federal government.
"This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota," Klobuchar said in a statement.
Similar bipartisan legislation will be introduced Friday in the U.S. House by Minnesota Republican Erik Paulsen, who's been working closely with klobuchar on medical device issues. Paulsen told MPR News that he's optimistic that his bills will be approved by the House sometime next year.
The medical device industry is a significant employer in Minnesota, accounting for nearly 30,000 jobs in the state according to the trade association AdvaMed. The industry also has a significant presence in Colorado, North Carolina, California and Massachusetts.
The Supreme Court has ruled that medical device manufacturers cannot be sued for faulty devices if the FDA has approved the device. This is called FDA Preemption. The FDA cannot be sued, the term is called Sovereign Immunity. So it appears that if you use a medical device and it harms or kills you there is no recourse, at least in civil court. Why anyone would want to weaken the FDA's ability to make certain devices are truly safe. Devices and even bandages get pulled for different problems fairly regularly. While this looks like getting "life-saving medical devices to the public quicker" it really is deregulation in an area where the public, if harmed, has no recourse.