Yesterday, the Health Subcommittee of the U.S. House Committee on Energy and Commerce held a hearing on the reauthorization of the Medical Device User Fee Act (MDUFA). Since 2002, MDUFA has required that the Food and Drug Administration collect fees from medical device companies seeking approval for devices they want to market in the U.S.
The reauthorization of the user-fee program is nothing new. However, the 14 bills introduced in Congress that threaten device regulation are indeed the latest attack on patient safety.
U.S. Rep. Henry Waxman (D-Calif.) called the bills in the House “industry’s wish list,” fulfilling most of the device industry’s desires to reduce already weak standards for approving medical devices and, thereby, expedite devices’ path to market.
Public Citizen’s new report, Substantially Unsafe, reveals that this $350 billion industry dispatched 225 lobbyists, including 107 who previously worked in government, to lobby on medical device regulatory issues in the 3rd and 4th quarters of 2011. The industry’s resources surged in the 4th quarter, when an additional 96 lobbyists (of the 225) and 23 new companies (of 53) joined the campaign. The device industry spent $33.3 million lobbying Congress in 2011.
While Congress is working to grant industry’s wish list, the industry also has done its best to fulfill the wishes of members of Congress. In 2011, members of industry hosted campaign fundraisers for at least 31 members of Congress. In just one month last spring, Representative Erik Paulsen (R-Minn.), who is either sponsoring or co-sponsoring all 10 of the industry-friendly House bills, received $74,000 from venture capitalists with a stake in device regulation.
As the industry “wish list” makes its way through Congress, the long list of needed patient safety reforms remains neglected. Patients need to know that the FDA will take necessary steps to block unsafe devices from reaching the market, develop a reliable system to notify patients who have been implanted with dangerous devices, and act quickly to remove defective devices once problems come to light. Finally, Congress should restore the rights of patients who have been injured by faulty devices to seek redress in court.
At present, the processes used to approve devices do not even come close to those required for approval of new drugs.
The number of device recalls has practically doubled in the past year, resulting in more than 1,200 recalls in the FDA’s 2011 fiscal year. High-risk recalls, like those for metal-on-metal hip implants and malformed surgical clips, tend to result from an approval system lacking in clinical testing, thorough manufacturing inspections, or both.
One would expect that recalled devices would be easily traceable to affected patients, similar to the ease with which recalled automobile parts can be traced back to affected cars. Yet, the FDA has yet to implement such a system.
When patients are harmed by defective devices, their rights to seek redress in court are severely limited. If the device has achieved the highest approval of the FDA, its manufacturer enjoys a near iron-clad immunity from litigation, compliments of Riegel v. Medtronic, the 2008 Supreme Court decision.