Minnesota Pols Slam FDA For Device Approvals

Minnesota Pols Slam FDA For Device Approvals

July 1st, 2011 // 12:39 pm @

In the ongoing war between device makers and the FDA, the Minnesota Congressional delegation has sent a terse letter to the agency over what they maintain is a slow-as-molasses approval process. This comes less than three months after a Congressional hearing in which FDA procedures were hotly debated and included testimony from patients who claimed tougher agency reviews would have prevented injuries.

At issue is the simmering tension between the agency, which embraces a get-tough policy on safety matters while lamenting a lack of sufficient funding, and an industry that wants to grow its bottom line but is also under a microscope – largely thanks to the ongoing Medtronic scandal over repudiated research and unseemly ties to physicians.

However, the Minnesota pols – a group that includes presidential aspirant Michele Bachman – cited a study conducted by the Institute for Health Technology Studies, an industry-backed group. This claimed to show that that nearly two-thirds of small medical device companies are seeking approvals in Europe before coming to market in the US .

They also cited investigational device exemptions, which allow an investigational device to be used in a clinical study in order to collect safety and effectiveness data. The percentage of IDEs that were approved fell from 76 percent in fiscal year 2000 to 56 percent in fiscal year 2009, despite increased funding through user fees. And in fiscal year 2010, 32 percent were approved in the first review cycle.

As a result, the delegation called the FDA IDE review process “inconsistent and unpredictable,” and added that “companies have faced significant delays in bringing their products to market,” which is leading to reduced venture capital investment in new products. So they asked FDA commish Margaret Hamburg to explain the drop in IDE approvals and how she is improving the process (read the letter).

Ironically, their missive comes less than three months after the US Government Accountability Office issued a report that slammed the FDA for failing to strengthen its approval and recall procedures for devices, despite an earlier recommendation to take “expeditious steps” for issuing regulations for high-risk devices that are approved under the less-stringent 510K process.

For instance, there were 3,510 voluntary recalls between 2005 and 2009, but the GAO found the FDA failed to regularly analyze the recall data. And the FDA had not set threshholds to determine whether recalls were completed correctly, failed to decide on a timely basis whether recalls were made properly and did not document justifications for terminating recalls .

Two months earlier, a study in the Archives of Internal Medicine found only a fraction of devices recalled by the FDA had been approved under the more stringent PMA process (read here). Of 113 devices recalled between 2005 and 2009, only 21 were approved through the more stringent pre-market approval process, which requires clinical tests and inspections. Meanwhile, 80 were cleared by the 510K process. The upshot: most devices recalled for life-threatening or very serious problems were originally cleared by the lower standard.

As an aside, four of the eight Minnesota delegates who sent the letter have received funding from Medtronic, one of the largest device makers, which is embroiled in a separate controversy over the safety of a product for which a slew of clinical research has been repudiated and a Congressional investigation is under way.

Who accepts Medtronic money? Besides Bachmann, contributions went to House reps Keith Ellison and Tim Walz, and US Senator Amy Klobuchar, according to the Center for Responsive Politics

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