A new agreement reportedly calls for medical device companies to pay $595 million in fees over five years, and for the FDA to add more than 200 people to its approval processes—which industry representatives have criticized as being too slow.
The medical device industry has reportedly agreed to double the fees it pays to the U.S. Food and Drug Administration (FDA) over the next five years, and the agency in turn will hire more staff and speed up the process for reviewing products.
The pact, announced Wednesday, is pending approval from Congress, according to the Star Tribune; it would replace a current five-year agreement between the two parties that’s set to expire September 30.
According to the Minneapolis newspaper, the agreement calls for medical device companies to pay $595 million in fees over five years, and for the FDA to add more than 200 people to its approval processes—which industry representatives have criticized as being too slow.
Under goals outlined Wednesday, the FDA would streamline its decisionmaking—ultimately dropping the timeframe for the pre-market approval process from an average of 464 days to 385 over the next five years, according to the Star Tribune. Meanwhile, the 410(k) process, the most common way for new devices to get the go-ahead, would reportedly drop from an average of 146 days to 124.
The agreement reportedly aims to stomp out last-minute requests for information by the FDA, which industry representatives have said slows the review process.
Medical device giants Medtronic and Boston Scientific were part of the negotiating team that formed the agreement with the FDA. Both voiced support of the arrangement.
In a statement provided to the Star Tribune, Fridley-based Medtronic said: “A strong and adequately resourced FDA is necessary to sustain public confidence and to achieve a more transparent, efficient, and accountable regulatory approval process for the innovations we bring to patient care. Achieving greater predictability and consistency in the approval process will not only affirm FDA’s important role in assessing product safety and effectiveness, but the management improvements envisioned by this new five-year user fee agreement will correct lagging review times and delayed patient access to new therapies.”
Meanwhile, Natick, Massachusetts-based Boston Scientific, which employs about 5,000 in the Twin Cities, told the newspaper it anticipates that the FDA “will be accountable to performance goals that are intended to ensure timely availability of safe, effective, and innovative medical devices to U.S. patients.”
U.S. Senator Amy Klobuchar—who co-chairs the Senate medical device caucus—told the Star Tribune that she thinks the agreement “will create a pathway to quicker approvals.” She added that she and U.S. Representative Erik Paulsen—who co-chairs the House medical device caucus—will partner in an attempt to gain bipartisan support for legislation also designed to accelerate the approval process.
To read more about the agreement in the Star Tribune, click here.
—Christa Meland
(cmeland@tcbmag.com)