Over the past several months, in anticipation of the upcoming changes to the FDA’s 510(k) approval program, policymakers and the medical device industry have been urging the Food and Drug Administration to reconsider changes that could impose stricter standards on device makers, and make the device approval process more uncertain.
Minnesota Senators Amy Klobuchar (D-MN) and Al Franken (D-MN), along with Congressman Erik Paulsen have been leading the charge in Congress to ask for these changes so that device makers can continue innovating medicine and medical technology without any added financial or regulatory burden. These policy makers have given “speech after speech and written letter after letter to the Food and Drug Administration” urging a more reasonable approach to the 510(k) proposed changes.
This message, although consistent, did not seem to have much impact on other policymakers. However, that changed last week when a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among “other things, to adopt a more deliberate, cautious approach to amending 510(k) versus the radical wholesale restructuring that medical device firms are fearing.”
The letter asserts that stricter 510(k) regulations will stifle innovation and economic growth, make American medical devices and technology less competitive compared to Europe and Asia, and will leave companies with unclear regulatory time lines.
As the MedCity News noted, “the letter is significant not just for what it says but who signed it: Klobuchar/Franken, Scott Brown/John Kerry (Massachusetts), Pat Roberts (Kansas), Ben Nelson/Mike Johanns (Nebraska), Kay Hagen (North Carolina), John Cornyn/Kay Bailey Hutchinson (Texas), Olympia Snowe (Maine), Evan Bayh (Indiana), Debbie Stabenow (Michigan), Bob Casey Jr. (Pennsylvania), and John Barrasso (Wyoming).”
This list of notable senators includes liberal Democrats and conservative Republicans. It includes senators from the East Coast, the Midwest, and the South. As the article noted, this letter demonstrated that the medical device issue is “suddenly not just a Minnesota gripe but a concern of national importance.” Accordingly, the author recognized that credit should be given to Senators Klobuchar and Franken for their dedication and efforts for “rounding up such an eclectic and diverse group of senators.”
States like “Minnesota, Massachusetts, Indiana and North Carolina, who all boast sizable medical technology clusters,” could be expected. However, no senators from California signed the letter, which is significant since California is the “home to some of the most innovative startups in medical devices today.”
MedCity News also pointed out that “senators from Florida and Arizona were also missing, which is significant since those are states that have large elderly populations” who probably benefit the most from new medical devices.
Ultimately, the senators recommended that the “FDA proceed cautiously” with its 510(k) changes, “Given the potential for enormous disruption in the innovation process.” Specifically, they asserted that FDA “should focus first on non-controversial proposals, but before any proposed change to the 510(k) is implemented, it is essential that FDA provide stakeholders ample notice and opportunity for comment.”
Additionally, the bipartisan group of 15 senators urged the FDA to operate “in a transparent fashion and provide greater detail on the specifics of each proposal before moving forward.” They also asked that the “FDA 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.”
This coordinated effort from a significant and diverse group of senators demonstrates that policymakers are listening to patients, companies, and consumers about their concerns for the potential negative consequences from a stricter medical device regulatory regime. It also shows that senators are recognizing the important role industry play in improving health care and outcomes for patients.
There is no doubt that safety and effectiveness are paramount to any decision that the FDA makes, however these considerations must be constantly balanced against the ability of industry to innovate and finance such devices in a predictable and reasonable manner, especially considering the significant risks they are already taking.