By: Joe Kimball
Minnesota's two senators and all eight members of Congress have sent a letter to the Food and Drug Administration, saying delays in review of medical devices "are hindering innovation, delaying patient access to new therapies, and undermining the U.S. medical industry's global leadership."
The letter was from Sens. Amy Klobuchar and Al Franken and U.S. Reps. Erik Paulsen, Collin Peterson, John Kline, Betty McCollum, Keith Ellison, Michele Bachmann, Tim Walz, and Chip Cravaack.
Minnesota is big in medical device technology, with more than 400 companies that employ more than 30,000 people.
Says the letter to Commissioner Margaret Hamburg:
Dear Dr. Hamburg,
We are writing in regards to the Food and Drug Administration's (FDA) Office of Device Evaluation's (ODE) Investigational Device Exemption (IDE) review process. Specifically, we are very concerned that delays in this process are hindering innovation, delaying patient access to new therapies, and undermining the US medical industry's global leadership.
U.S. medical technology companies have historically led the world with ground-breaking innovations that improve patient care. They are also a key force within the US economy, providing well-paying jobs and remaining one of the few manufacturing sectors with a consistently positive balance of trade. The majority of these companies are small businesses, with 50 employees or less -- the core of American innovation and economic growth. However, a recent survey of the medical device industry conducted by the Institute for Health Technology Studies showed that we are losing our leadership in this area. The study found that nearly two-thirds of small medical device companies are seeking approvals in Europe before coming to market in the United States.
A review of ODE's annual reports over the last decade show a clear pattern of decline in the percentage of IDE's approved on the first IDE review cycle, dropping from 76% in FY2000 to 56% in FY2009. Despite a decrease in the number of original IDE's submitted and increased funding through user fees, companies are still facing hurdles in IDE first approvals. Most alarming, are the FY2010 figures, released by ODE per the MDUFMA III negotiations, which show only 32% of IDE's are approved on the first review cycle.
Recent studies, including those compiled by Dr. Josh Makower, MD, of Stanford University and PricewaterhouseCoopers, have shown that the FDA IDE review processes is often inconsistent and unpredictable. Due to this, companies have faced significant delays in bringing their products to market. Additionally, this uncertainty has resulted in reduced venture capital investment in new products.
While we support your mission of ensuring that safe and effective devices reach the marketplace, we feel that we can achieve that goal while still balancing our ability to develop innovative and life-saving therapies.
We request that you provide an explanation for the cause of the 43% drop in IDE's approved on the first review cycle between FY2009 and FY2010. Additionally, in light of the recent directive by President Obama to eliminate unnecessary delays and regulations within FDA, we would like your feedback on what steps you are considering to improve the IDE review process.
Thank you for your attention to this important matter, and we look forward to your response.