CONSUMERS UNION NEWS
RELEASE
Thursday, April 19, 2012
Medical Device Bills
Missing Critical Patient Safety Protections
Medical Device User Fee
Bills Face Key Votes in Congress Next Week
WASHINGTON, D.C. – Key House and
Senate Committees will vote next week on legislation to reauthorize the statute
governing medical devices at a time when the law has come under increasing
criticism for failing to ensure devices are safe and effective. While the
Senate legislation is stronger than the House version, neither bill includes
critical reforms needed to protect patients from dangerous or defective
devices, according to Consumers Union, the policy and advocacy arm of Consumer
Reports.
“Our system for overseeing
medical implants and other high risk devices is clearly broken and allows too
many dangerous devices on the market,” said Lisa McGiffert, director of
Consumers Union’s Safe Patient Project. “Tens of thousands of patients
have been injured or died in recent years because current law fails to ensure
medical devices are safe. Unfortunately, these bills don’t fix the most
serious flaws in our current system and leave patients at risk.”
The Senate Health, Education,
Labor and Pensions Committee will hold a mark-up of its bill to reauthorize the
Medical Device User Fee Act on Wednesday, April 25. The House Energy and
Commerce Committee’s Health Subcommittee will mark up its bill on Thursday,
April 26.
Despite the fact that 78 percent
of high-risk medical devices are reviewed through the FDA’s fast track 510(k)
process, industry lobbyists have urged Congress to ease federal oversight in
order to promote innovation and speed up new device approvals. But according to a March 2012 Consumer Reports poll, 82 percent of Americans
believe that preventing safety problems is more important than limiting safety
testing in order to prevent delays and encourage innovation.
“We all want patients to get timely access
to effective new medical technologies,” said Lisa Swirsky, senior policy
analyst for Consumers Union. “But Congress needs to make sure that
patient safety isn’t sacrificed in the drive to speed up medical device
approvals.”
The House bill is
particularly weak, according to Consumers Union. Among other things, it
diverts the FDA’s mission of protecting public health to include job creation
and innovation and constrains the FDA’s ability to get needed clinical
data from manufacturers. The Senate bill includes
some important reforms, including streamlining the process for “up-classifying”
devices so they can be subject to more rigorous review. But a number of
critical protections are missing from both the House and Senate bills,
including:
Prohibition on clearing new
devices based on recalled devices: The FDA clears more than 90
percent of all medical devices without requiring any clinical testing.
These devices are cleared based on whether they are “substantially equivalent”
to existing devices already on the market. Under the 510(k) process, the
FDA has to approve a new device if the manufacturer proves it is similar
to a previously cleared one, even when the existing device has been recalled
because of safety problems.
The Senate and House bills do not
include a provision preventing medical devices with known safety problems from
being used as the basis for clearing new devices. Currently, the FDA does
not even have the authority to require manufacturers seeking clearance for new
devices to demonstrate that they have addressed the flaws of the recalled
device.
Consumers Union has urged Congress to
prohibit recalled devices from being used as predicates for new devices.
The Consumer Reports poll found that 71 percent of Americans believe that
a new medical device should not be allowed to be sold based on its similarity
to an existing implant that has a safety problem or has been recalled.
A system to monitor devices after they
are cleared for sale: The FDA does not have the tools and resources
to adequately track and evaluate how patients with implants and other high-risk
devices are faring. The Senate bill provides some improvement in this
area while the House bill does not. Five years ago, Congress
required the FDA to create a Unique Device Identifier (UDI) system to monitor
what happens to implants once they are on the market, but it is still not in
place. UDIs are essential for including devices in the Sentinel Initiative, a
surveillance system currently being implemented that monitors how prescription
drugs perform once on the market. The Senate bill officially includes
medical devices in the Sentinel Initiative and reaffirms the importance of
implementing the existing UDI requirement by establishing a December 31, 2012
deadline for promulgating the UDI regulations.
UDIs coupled with a national registry
of patients with devices would help the FDA more quickly identify problem
devices and notify patients when their device has safety problems or has been
recalled. The Senate and House bills do not address the need for a
national registry. The Consumer Reports poll found that 95 percent
of Americans believe that effective consumer protections for medical implants
should include a nationwide system for tracking medical implants so patients
can be notified about safety problems or recalls.
Stronger authority for the FDA to
require post market studies: The FDA currently does not have the
authority to require post market studies of new devices as a condition for
clearing them through the 510(k) process. Further, if the agency issues
an order for a “522 study,” which can now be required when safety concerns
arise after a device is cleared for the market, it doesn’t have the authority
to rescind the clearance of the device if the device maker fails to comply with
the order or if the study shows that the device is unsafe or ineffective. Neither the House nor the Senate bill provides
the FDA with these needed powers.
The Senate bill improves current law by
establishing a timeline for 522 studies. However, the bill allows manufacturers
to delay beginning these studies for fifteen months after the FDA orders
them. While these studies are being conducted, doctors can still
implant these questionable devices in patients.
Retaining Existing Conflict of Interest
Standards: Both the House and Senate bills weaken current standards that
aim to prevent conflicts of interest on FDA panels that review medical devices
and prescription drugs. The bills eliminate existing limits on the number
of waivers the FDA may grant to experts with financial ties to the medical
device industry. These limits were championed by consumer advocates and
adopted by Congress just five years ago. The House bill also eliminates
certain disclosure requirements for FDA advisory panelists. The FDA has
provided no substantial evidence to demonstrate a problem with finding experts
without conflicts. The Consumer Reports
poll found that 66 percent of Americans had a high level of concern about the
safety decisions or recommendations made by expert committees that included
doctors who had current financial relationships with medical device
makers.
Michael McCauley, mmccauley@consumer.org, 415-902-9537 (cell)
Daniela
Nuñez
Grassroots
Organizer
Twitter:
@CUSafePatient
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