A new report by the watchdog group Public Citizen exposes the massive lobbying efforts by the medical device industry designed to weaken already lax oversight and hasten review of high-risk products.
The report “Substantially Unsafe” coincides with today’s hearing in the U.S. House of Representatives over the re-authorization of the Medical Device User Fee Act (MDUFA) and highlights the dangerous influence corporate lobbyists play in writing our laws.
For example, the report highlights that the device industry dispatched at least 225 lobbyists, including 107 previously employed by the federal government, to work on medical device regulatory issues in just the third and fourth quarters of 2011. Nearly half of these lobbyists entered the legislative push in the fourth quarter, as Congress prepared to take up the issue. These lobbyists sponsored at least 40 fundraisers for members of Congress in 2011. The industry spent $33.3 million on lobbying in 2011, bringing its total to $158.7 million since 2007. The industry has made nearly $20 million in campaign contributions to federal candidates since the 2006 election cycle with sponsors of 10 House bills that try to weaken FDA approval standards receiving a near three-fold increase in campaign funds.
“The industry is campaigning for expanded regulatory loopholes and subpar standards – measures that would put more and more patients at risk for encountering unsafe devices. These demands represent exactly the wrong course of action for Congress,” said Negah Mouzoon, researcher with Public Citizen’s Congress Watch division and the lead author of the report. “Congress instead should insist that standards be strengthened and that the FDA step up its efforts to remove demonstrably dangerous devices from the market.”
In fact, the report uncovers that the need for stronger FDA oversight and enforcement, not the opposite. The Food and Drug Administration (FDA) receives reports of more than 200,000 device-related injuries and malfunctions every year, and more than 2,000 deaths. In recent years, recalls for both moderate and high-risk devices have more than doubled .
The report identifies a handful of problem devices to underscore this point. Recently recalled devices include an implantable pad designed to shield breast tissue from radiation treatment that sheds small particles of tungsten into the breast; an infusion pump that shuts down unexpectedly or dispenses an incorrect dose of medicine; faulty defibrillators that inappropriately deliver severely painful and potentially dangerous electrical jolts to the heart; a surgical clip designed to clamp off arteries that pops off, causing patients to bleed to death internally; and an artificial hip that sheds metal fragments into the bone and surrounding tissue, wearing away tissues and causing extreme pain and limited mobility.
For those riskiest devices approval is often easiest to come by, and industry lobbyists are working hard to make this flawed process even worse. The process for approving the highest-risk products (called the premarket approval (PMA) process) is much weaker than that used for approving new drugs.
Worse, the process used to clear at least 95 percent of moderate- and high-risk medical devices is shockingly less stringent than that used for the sliver of devices subject to the PMA process. This process, called the 510(k) process after a section of legislation, clears devices based on a mere demonstration that they are “substantially equivalent” to devices already on the market, which provides little assurance of safety or effectiveness, especially because most of the existing products were never demonstrated to be safe or effective. The Institute of Medicine in 2011 recommended that the FDA scrap the 510(k) process because it does not ensure safety or effectiveness.
The changes industry lobbyist are pushing for would ultimately undermine the entire purpose of the agency. These bills would further reduce already weak standards for clearing and approving medical devices; shift the emphasis of the FDA’s mission from protecting public health to promoting medical innovation; weaken the “conflict of interest” prohibition for serving on the FDA advisory committee that oversees device approvals; expand “third-party” companies that can review a device application to include those with significant financial relationships with the device industry; and more.
“Many patients would be shocked to learn that, unlike prescription and over-the-counter drugs, many moderate- and high-risk devices, including many that are surgically implanted, have either never been tested to ensure that they are safe and effective or have undergone woefully inadequate testing,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group and co-author of the report. “Congress should reject the medical device industry’s lobbying campaign to weaken medical device regulations and instead require a dramatic overhaul of the device approval and clearance processes to improve patient safety.”
Congress is right to review the medical device clearance and approval process, but what it is considering as a replacement is simply unacceptable. Public Citizen has outlined a series of reforms that would represent real protections for consumers without stifling innovation and growth. Among those reforms include a call to Congress to replace the medical device clearance and approval processes with a process that requires the same scrutiny as new drugs. In the interim, Congress and the FDA should require additional safeguards for the current 510(k) process, more rigorous clinical trials for PMA applications, stricter reporting of adverse events, the maintenance and analysis of a database of device recalls to ensure that they are implemented effectively, and improved device tracking to patients.
Congress also needs to restore the ability of patients to sue certain manufacturers of defective devices– a right taken away in the 2008 Supreme Court decision of Reigel v. Medtronic.
Without an effective and aggressive FDA to police the medical technology industry consumers will fall prey to the drive to maximize corporate profits. We should not allow corporate interests to trump public welfare in any context, but this is especially true with regards to health care where lives are quite literally on the line.
Photo from tracy o via flickr.