According to an story by the New York Times, companies or associated individuals developing new medical devices and other health products have made more than $3.3 million in political donations to members of Congress and political action committees over the past five years. Speculating on the reasons for the donations results in various answers, but the analysis by the paper identified that about 20 percent of the money went directly to candidates and political action committees supporting a streamlining of FDA policy or other issues of importance to medical device makers.
As Congress considers reauthorizing the medical device user fees beyond fiscal year 2012, it is not unusual to see an uptick in the amount of political contributions made by businesses to tilt the balance in their favor. An opportunity to alter the FDA’s regulatory procedures for the first time since the medical device user fees last came up for renewal in 2007 means medical device manufacturers are not sitting idly on the issue. In October, bills were introduced by Republicans in the House to speed up the FDA’s device approval process; in the Senate, similar legislation was introduced by a Democrat whose state has a large medical device manufacturer presence. A major medical devices lobby organization, the Advanced Medical Technology Association, spent over $365,000 in 2011 Q2.
Another interesting item of note is that venture capitalists are joining device companies in the drive to remove perceived regulatory roadblocks in the medical device approval process. The National Venture Capital Association intensified its focus on device regulation, spending $350,000 on medical device lobbying for 2010. The association stated that this figure is expected to increase to $450,000 this year. The push has alarmed patient advocates and some doctors, who have been calling on the FDA to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.
Beyond the push for a faster approval process, medical device manufacturers are also seeking to have a 2.3 percent excise tax on U.S. sales of certain medical devices, from stents and defibrillators to artificial hips and bedpans repealed before it goes into effect in 2013.
The impact on patients utilizing medical devices is still to be determined. On one side of the equation, faster approval of medical devices adds an incentive for some manufacturers to invest in R&D for devices that would be normally tied up in a longer FDA approval cycle. On the other side of the equation, concerns about the speed of regulatory approval do not address the recent report that the FDA failed to properly assess the safety and efficacy of devices; an expedited system could mean additional problems.