MN Reps. Voice More Concerns Over FDA Regs.
Local concerns over U.S. Food and Drug Administration (FDA) processes and regulations continue to pile up.
On Thursday, Minnesota's Congressional delegation sent a letter to FDA Commissioner Margaret Hamburg voicing concerns over delays in the FDA's investigational device exemption (IDE) review process.
IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to gain a pre-market approval.
In their letter, state representatives said that they are very concerned that delays in the IDE process are “hindering innovation, delaying patient access to new therapies, and undermining the U.S. medical industry's global leadership.”
The congressional members say that annual reports from the FDA's Office of Device Evaluation show a pattern of decline in the percentage of IDEs approved on the first IDE review cycle-dropping from 76 percent in 2000 to 56 percent in 2009. They added that the most alarming figures are from 2010, which show that only 32 percent of IDEs were approved on the first review cycle.
Also cited in the letter are recent studies-including those compiled by Josh Makower, MD, of Stanford University and PricewaterhouseCoopers-which have shown that the IDE review process is often “inconsistent and unpredictable.”
“Due to this, companies have faced significant delays in bringing their products to market,” they wrote. “Additionally, this uncertainty has resulted in reduced venture capital investment in new products.”
The representatives requested that the FDA explain the drop in IDEs and share the steps that the agency is taking to improve the IDE review process.
An FDA representative could not be reached for comment on the letter.
Changes to the FDA's 510(k) device approval process have also garnered the attention of local representatives. Thursday's letter came slightly more than a week after Senator Al Franken sent a letter to Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, asking the agency to consider the medical device industry's input before making additional changes to the 510(k) device approval process that are now under consideration.
Late last year, Minnesota legislators on both sides of the political aisle voiced concern about proposed changes to the 510(k) process, and Congressman Erik Paulsen has also voiced his concerns over the lack of “consistency, predictability, and transparency” in the FDA's pre-market review processes.
Earlier this year, the FDA released a plan to update the 510(k) approval process-a 35-year-old system used to approve the majority of medical devices for market. That plan contains 25 actions that the agency intends to implement this year. A handful of those actions have already been put into practice, but most of them are scheduled to be implemented later this year.
In addition to the 25 actions that are already being implemented, the FDA has identified seven more controversial recommendations, including clarifying and consolidating some regulatory terms, and clarifying when a device should no longer be available for use as a predicate-a device that is already on the market that can be used to help a similar devices gain FDA approval.
Those recommendations are being reviewed by the Institute of Medicine (IOM), and the FDA expects to receive feedback from the IOM sometime this summer.