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Two Studies Question FDA Approval Methods For Heart Devices

December 30, 2009
Two separate studies published in different journals come to the same conclusion: based on reviews of the evidence submitted by manufacturers of cardiovascular medical devices, the US Food and Drug Administration’s premarket approval process is not as stringent as it should be. In the report published in the Journal of the American Medical Association researchers looked at 123 summaries of safety and effectiveness relating to 78medical devices introduced between 2000 and 2007. Their study shows that FDA approval is often based on “studies that lack adequate strengthand may be prone to bias.” For instance, 51 of the 78 approvals were based on just one study, with standards far weaker than those used for drugs. According to the researchers, "The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can.” The other study, published in the American Journal of Therapeutics, looked at 87 devices and 132 clinical studies and included a medical reviewer from the FDA's cardiovascular device division among its authors. The researchers concluded that cardiovascular device studies submitted to the FDA often lack detail. “Poorly defined safety and effectiveness end points, poor patient accounting and incomplete collection of important patient comorbidities make device safety and effectiveness assessments more challenging. Women, pediatric, and nonwhite populations are underrepresented in premarket cardiovascular clinical trials,” they write, concluding,  “Manufacturers, regulators and the clinical community should collaborate to address these study shortcomings to ensure that patients are treated with reliable, safe and clinically useful medical devices.”