Minnesota Lawmakers Remain at Forefront of Medical Device Discussions Being one of the states most

Minnesota Lawmakers Remain at Forefront of Medical Device Discussions
Being one of the states most dependent upon the manufacture and sale of medical devices for its economy, Minnesota has been deeply invested in the laws and legislation being passed in Washington, D.C., regarding medical device regulation and taxation. In August, U.S. senators from Minnesota Amy Klobuchar and Al Franken, both Democrats, met with U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to discuss how the state might be able to speed up approval processes and create more medical device sales jobs.

The senators pressed Hamburg for reforms that will encourage innovation and job growth in Minnesota, which is home to a number of major medtech players such as Medtronic Inc. and St. Jude Medical Inc.

“Minnesota’s innovative medical device industry not only creates tens of thousands of well-paying jobs in our state, but also produces internationally respected life-saving devices,” Franken said. “Today’s meeting was a great opportunity for the FDA to get a better understanding of the hurdles our companies often face when trying to bring their lifesaving products to market in the quickest, safest way possible.”

Both senators have made it an important part of their platform to fight specifically for medical device businesses in Minnesota, especially startups. “Over the past few years the FDA’s regulation has become increasingly longer and more difficult, delaying, and in some cases preventing, new and innovative devices from reaching the market,” Klobuchar explained. “That is why I introduced bipartisan legislation—the Medical Device Regulatory Improvement Act—that would help streamline the FDA’s regulation of medical devices by clarifying FDA’s current least burdensome requirements. Key provisions of this bill to promote innovation and help get new, lifesaving products to the market quicker without compromising patient safety were signed into law in July 2012.”

The Senators praised the FDA’s Safety and Innovation Act, which was signed into law in July and helps streamline the regulatory process for medical device sales approval. The Act gives the FDA the authority to collect user fees from industry to fund reviews of various products, including medical devices, thereby making review times faster and more efficient.

“Support for FDA user fees is a testament to the important role FDA plays in America’s healthcare continuum,” Hamburg said when the bill was passed. “FDA’s medical product decisions sit at the intersection of public health, innovation, and commerce, and touch the lives of nearly every American every day.”

The full impact of the bill will likely not be felt across the industry for another five to six years, and that is driving states with a vested interest in the industry to keep the pressure on regulatory officials.