US Congress Wading into FDA Reform Debate
Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the House Energy and Commerce Health Subcommittee. That could mean at the very least Congressional hearings on whether and how the FDA medical device clearance and approval processes should be changed, and at most legislative intervention to quash efforts to step up the regulator’s review and enforcement powers. In an op-ed published February 15 in The Hill, Pitts took specific issue with recent studies showing the European device review process to be faster and cheaper than the US model, and how that alleged shift will impact both US innovation and patient access to cutting-edge medical products. Arguing that the FDA has become too “risk-averse,” Pitts wrote that his subcommittee would further investigate why and how the US has lost ground to Europe in terms of medical device innovation, faster time to market and flow of venture capital. The recent AdvaMed-sponsored study by Boston Consulting Group, which compared recall rates between US and European markets, featured prominently in Pitts’s argument. No mention, alas, of a recent study published in the Archives of Internal Medicine noting that the majority of high-risk device recalls in recent years involved products cleared through the FDA’s less stringent 510(k) process.