With the reauthorization of the Medical Device User Fee Act (MDUFA) currently being debated in Congress, medical device industry lobbyists, congressmen, and consumer watchdog groups are locking horns in a battle for the future of medical device regulation.
The MDUFA, which has to be reauthorized every five years, requires a user fee to be levied on medical device manufacturers seeking approval for a new device. A recent agreement reached between the industry and the U.S. Food and Drug Administration (FDA) would double the current user fee level – fees the agency claims are needed to hire more qualified device reviewers and managers to speed up the approval process.
Some consumer groups are crying foul. Public Citizen, a consumer watchdog group, claims that members of Congress, influenced by powerful medical device industry lobbyists, have introduced 14 bills that aim to speed up the approval process at the expense of patient safety. They go on to state that the current approval process is far less rigorous than the one used for new drugs, and point to a study by the Institute of Medicine that concluded the FDA process used to clear 95 percent of moderate- and high-risk medical devices, and even the process for approving the highest-risk devices, fails to ensure they are safe and effective.
200,000 medical device-related injuries and malfunctions – and more than 2,000 deaths – are reported to the FDA every year.
In 2011 the medical device industry spent $33.3 million on lobbying in Washington D.C. The law firm of Farah & Farah believes that patient safety, and not profits, should always be the most important consideration when medical devices are approved for use. If you believe you have been injured because of a faulty or malfunctioning medical device, call our Florida medical defect lawyers at (800) 533-3555 for a free and discreet consultation.
Sources: http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx; http://www.medpagetoday.com/Washington-Watch/Washington-Watch/31200