According to a recent New York Times business article, venture capital funds are contributing to the campaigns of politicians calling for streamlined Food and Drug Administration (FDA) medical device approval procedures and increasing their lobbying presence in Washington, D.C. This activity is partially attributed to the need for congressional reauthorization of the law that requires medical device makers to pay fees to FDA, giving lawmakers their first opportunity to amend the agency’s procedures since 2007.
With a spate of new regulatory reform bills specifically targeting medical device regulation pending before the House and Senate, a legislative battle is apparently brewing. In 2011, House committees have conducted a number of hearings focusing on FDA medical device procedures, with most of the witnesses representing investors, entrepreneurs, industry consultants, trade group officials, or patients claiming that agency delays had harmed them or a family member.
House Democrats have reportedly expressed concerns about imbalanced testimony, suggesting that the hearings, by excluding witnesses injured by purportedly flawed devices, have failed to consider potential dangers “if medical devices are not appropriately regulated.” Industry supporters contend that FDA approval delays are caused by personnel turnover, an unwieldy bureaucracy and top officials who have overreacted to recent problems with medical devices by becoming risk-averse. One industry analyst noted that investors are particularly concerned with the speed of approval because this begins a process of start-up acquisition in which early investors, who may not be as concerned about patient experience with a device, profit by cashing out. See The New York Times, October 25, 2011.