Oct 12, 2011
Today Reps. Henry A. Waxman, Frank Pallone, Diana DeGette, and John D. Dingell sent a letter to Chairmen Fred Upton, Joseph R. Pitts, and Cliff Stearns urging the Committee to hold hearings to examine medical devices that have developed serious defects after being implanted in patients. The Committee’s hearings to date have focused on claims about FDA overregulation and consequent harms to industry. Brain stents and metal-on-metal hip implants are recent examples of devices that merit further investigation to determine whether there are harms associated with underregulation.
The full text of the letter is below and also available online here.
October 12, 2011
The Honorable Fred Upton
Chairman
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515
The Honorable Joseph R. Pitts
Chairman
Subcommittee on Health
2125 Rayburn House Office Building
Washington, DC 20515
The Honorable Cliff Stearns
Chairman
Subcommittee on Oversight and Investigations
2125 Rayburn House Office Building
Washington, DC 20515
Dear Chairman Upton, Chairman Pitts, and Chairman Stearns:
Over the past year, the Committee has held four hearings on FDA regulation of medical devices. These hearings primarily served as forums for critics of the FDA who allege that the FDA regulatory process for devices harms patients and has a negative impact on jobs.[1] Some witnesses have even advocated that we change our standards for clearance and approval, a recommendation not supported by Advamed, a leading association of medical device manufacturers.[2] The hearings have not provided a balanced and accurate picture that fully reflects the role FDA plays in reviewing device applications; nor have they spoken to the potential dangers posed to patients if medical devices are not appropriately regulated.
As the Committee embarks on the reauthorization of the medical device user fee program, we write to urge that we hold hearings that examine medical devices that have developed serious defects after being implanted in patients. Specifically, we believe that looking further into the “metal-on-metal” hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices. We believe hearings on these topics would provide important information for members to evaluate in the context of the reauthorization of the medical device user fees.
Both items are examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA. As such, we believe they could provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.
Brain Stents
Brain stents were a promising new device designed to open up a blocked artery in the brain following a stroke in the hope of preventing additional strokes. The Wingspan Stent System was approved by the FDA in August of 2005 for patients with a greater than 50% blockage in an artery and whose condition was refractory to medical therapy.[3] The device was approved under a humanitarian device exemption (HDE) application. The HDE process allows a manufacturer to bypass the scrutiny of the full premarket approval process if the device is intended to diagnose or treat a disease or condition that affects fewer than 4,000 people, so long as no other non-HDE device is available to treat that disease or condition. A manufacturer applying under the HDE option must comply with certain conditions, including a general prohibition on profit for the HDE device.[4]
Under the lesser HDE standard of approval, the Wingspan stent system was approved on the basis of registry data for some 45 patients.[5] A recent trial sponsored by the National Institutes of Health including 451 patients demonstrated that 14.7% of patients with a recent stroke who had a stent implanted had a stroke or died within 30 days, as compared to 5.8% of the patients without a stent and only on medical management—more than double the rate of strokes and deaths within 30 days for patients with a stent.[6] According to press reports, thousands of patients have received this implantable device.[7]
Metal-on-Metal Hip Implants
Metal-on-metal hip implants have also garnered close attention over the past year.[8] Artificial hips replace the ball-and-socket structure of the hip with an artificial ball sitting inside an artificial cup placed into the hip. The artificial hip can be constructed from a variety of materials. “Metal-on-metal hips” refer to hips where both the ball and the cup are made of metal. According to the New York Times, of the estimated 250,000 hip replacements each year, nearly one-third are now metal-on-metal hip implants, and an estimated 500,000 patients have received an all-metal replacement hip.[9]
The devices were cleared under the 510(k) clearance process, meaning that the devices had to demonstrate that they were “substantially equivalent” to one or more devices already on the market. Although clinical data can be required under this clearance process, many submissions are cleared without such data. According to press reports, many of the metal-on-metal hip systems were cleared this way.[10] As of December 31, 2010, FDA had cleared for marketing 175 submissions for metal-on-metal hips through the 510(k) process, many of which were components of larger systems.[11]
The metal-on-metal hip implant systems have “unique risks in addition to the general risks of all hip implant systems,” according to the FDA.[12] Because the metal rubs against the metal, “tiny metal particles may wear off of the device and enter into the space around the implant…[or] even get into the bloodstream.”[13] For some patients, these metal particles can cause damage to the bone or tissue surrounding the implant and joint, requiring a surgery to replace the implant. In addition to the local reactions, “high levels of metal ions in the bloodstream may cause symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland.”[14]
Many of these devices were approved first in the United Kingdom (UK) and elsewhere abroad. The early UK experience suggests that these “unique risks” make the devices much more prone to failure, with as many as one-third of certain models failing in registries in the UK.[15] Indeed, a study in the UK found that the metal-on-metal hips failed early at a rate three times that of hips made of different materials.[16]
In this country, only a small fraction of the 500,000 people who received this device are known to have suffered injury. But the United States does not have a registry for these devices similar to the one in the UK. Since January of this year, FDA has received over 5,000 complaints about the metal-on-metal hips.[17] Two metal-on-metal hip systems have already been voluntarily recalled.[18] These concerns led FDA to order 20 manufacturers of these devices to submit a plan to the FDA to study how frequently they were failing and to examine the health implications of device failures.[19]
Conclusion
To date, the Committee’s hearings on medical devices have examined claims about delays in FDA approval and overregulation.[20] We agree that innovative products that help patients should get on the market quickly, and we are supportive of the efforts by the Administration to improve efficiencies and streamline the approval and clearance process.[21] We are also open to other ways to speed the process.
But while working to reduce inefficiencies at FDA, it is critical that we also protect patient safety. Unfortunately, we believe the hearings to date have provided members with an incomplete record. We should also be examining evidence as to whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices.
Brain stents and metal-on-metal hip implants are recent examples of devices which merit further investigation and hearings to determine whether there are harms associated with underregulation.
In addition, we believe it is imperative that we hold hearings on the recent Institute of Medicine report, which concluded that our current review system needs to be strengthened—not weakened—to ensure that medical devices are safe and effective.[22] This would be in keeping with the Committee’s activities in 2006 and 2007, when we examined an Institute of Medicine report that recommended changes to the drug evaluation system. At that time, many of the Institute’s recommendations were supported in a bipartisan fashion in the Food and Drug Administration Amendments Act of 2007.[23]
We believe that the reauthorization of the medical device user fees program can and should be a bipartisan process. This is a critical opportunity to improve the efficiency of the process while at the same time strengthening assurances of safety and efficacy. Hearings to ensure that all relevant sides of the issue can be fully examined by the Committee, including the importance of safety, are critical to ensure a balanced perspective for members.
Sincerely,
Henry A. Waxman
Ranking Member
Frank Pallone
Ranking Member
Subcommittee on Health
Diana DeGette
Ranking Member
Subcommittee on Oversight and Investigations
John D. Dingell
Member of Congress
