Minnesota, Sens. Amy Klobuchar (D) and Al Franken (D) along with Rep. Erik Paulsen (R), have championed the medical device industry with speeches and letters to the Food & Drug Administration about upcoming changes to the 510(k) approval program.
The FDA is now close to releasing its recommendations on 510(k) changes and Minnesota’s congressional delegation is again beginning to show its support for the medical device industry.
On Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg, urging the agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k) versus the wholesale restructuring medical device firms are fearing.
The letter is significant not just for what it says but who has signed it: Sens. Klobuchar, Franken, Scott Brown (R-Mass.). John Kerry (D-Mass.), Pat Roberts (R-Kan.), Ben Nelson (D-Neb.), Mike Johanns (R-Neb.), Kay Hagen (D-N.C.), John Cornyn (R-Texas) Kay Bailey Hutchinson (R-Texas), Olympia Snowe (R-Maine), Evan Bayh (D-Ind.), Debbie Stabenow (D-Mich.), Bob Casey Jr. (D-Pa.), and John Barrasso (R-Wyo.).
Liberal Democrats. Conservative Republicans. East Coast. Midwest. South. Suddenly, the issue is a concern of national importance.
Minnesota, Massachusetts, Indiana, and North Carolina boast sizable medical technology clusters, but California Sens. Barbara Boxer and Diane Feinstein are missing from the list despite the state’s large device cluster. Senators from Florida and Arizona, states with large elderly populations, also did not sign the letter.
The letter’s arguments against a stricter 510(k) process are that it will stifle innovation and economic growth, cause the country to fall behind Europe and Asia and cause unclear regulatory time lines.
The letter also offers specific advice to the FDA:
Given the potential for enormous disruption in the innovation process, we believe FDA must proceed cautiously. We believe FDA should focus first on non-controversial proposals, but before any proposed to the 510(k) is implemented, it is essential that FDA provide stakeholders ample notice and opportunity for comment.
In addition, we believe FDA must operate in a transparent fashion and provide greater detail on the specifics of each proposals before moving forward. And FDA should carefully consider the impact of any proposed change on the ability of companies to innovate in a predictable and consistent regulatory environment so they can continue to bring medical advances to patients.