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Minnesota lawmakers critique FDA medical-devices policy over IDEs

The medical device industry’s favorite Congressional delegation has fired another salvo at the FDA approvals process.

Minnesota’s entire Congressional delegation sent a letter Thursday to U.S. Food and Drug Administration Commissioner Margaret Hamburg saying they are “very concerned” about the Investigational Device Exemption (IDE) review process. The delegation cites some of the industry’s favorite — albeit often criticized — research as well as annual reports from FDA’s Office of Device Evaluations to show that in fiscal 2009 just over half (56 percent) of the devices in the first review cycle for an IDE application actually received it, down from 76 percent in fiscal year 2000.

That figure was further reduced to an “alarming” 32 percent of applications in the first review cycle in 2010 that were granted an IDE, according to the delegation’s letter.

The legislators requested an explanation for the dramatic drop in IDEs granted between 2009 and 2010. “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,” the letter noted.

FDA spokeswoman Karen Riley responded: “Let me remind you that behind the statistics are decisions being made about whether to study real people. They are not statistics.”

Thursday’s letter comes a week after Democratic Sen. Al Franken sent a letter to Dr. Jeffrey Shuren, who heads up the Center for Devices and Radiological Health at the FDA. Franken asked the agency to include industry perspective once the Institute of Medicine comes out with its recommendations for the 510(k) approval process and before any final changes are made to it.

The Institute of Medicine has been charged with making suggestions on improving the 510(k) approvals process, which historically provided clearances in 90 days for new devices that had a similar product existing in the marketplace. In recent years, that 90-day window has lengthened, complain the medical device industry. The IOM report is due this summer.

A full text of Thursday’s letter is below:

Dr. Margaret Hamburg
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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.

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