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June 13, 2012 (FiDA blog bold,underline added)
Washington, D.C. – Consumers Union, the policy and advocacy arm of Consumer
Reports, urged House and Senate leaders today to adopt a number of provisions
from the Senate’s FDA User Fee Act that would better protect patients from
potentially dangerous medical devices than the version passed by the House.
The House and Senate are expected
to vote on a final version of the legislation before the July
4th congressional recess.
Recent safety problems with
defective hip implants, defibrillators, and surgical mesh have harmed tens of
thousands of patients and underscored the need for stronger federal oversight
of these products.
“The FDA needs stronger tools to
ensure medical devices don’t harm the patients they’re intended to help,”
said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.SafePatientProject.org).
“The Senate bill does more to enhance the FDA’s ability to better monitor
devices once they are on the market and to make it easier to notify patients
and require stricter testing when safety problems come to light. We
urge Congress to adopt the stronger patient safety provisions in the Senate
bill.”
The House legislation does include
a number of patient safety measures that were close to the Senate’s version –
adding devices to the post market surveillance Sentinel Initiative and
setting a deadline for regulations to be finalized for unique device
identifiers. But in each case, the Senate language is stronger.
Neither the House nor the Senate bill does enough to ensure devices are safe
and effective before being cleared by the FDA for the market, according to
Consumers Union.
Below is the letter Consumers Union
sent to the leaders of the Senate Health, Education, Labor, and Pensions
Committee and the House Energy and Commerce Committee about the legislation:
June 7th, 2012
Dear Chairman Harkin, Ranking
Member Enzi, Chairman Upton, and Ranking Member Waxman:
Consumers Union, the advocacy arm
of Consumer Reports, thanks you for your commitment to ensuring that our
national system for approving drugs and devices brings safe products to the
market for patient and consumer use. As you move forward in reconciling the
differences between the Senate and House versions of the reauthorization of
the FDA User Fee Act, please consider our top priorities, presented below:
Unique Device Identifier (Senate,
Sec. 607) – Support Senate.
We see
implementation of this current law as soon as possible as a high priority on
medical devices. While it is encouraging that both Senate and House versions
address finalizing the UDI rule, we support the Senate version because it
sets a deadline for implementing UDIs for high risk, life sustaining and
implantable devices. The FDA does not currently have the tools and
resources to adequately track and evaluate how patients with implants and
other high-risk devices are faring. Effective post-market surveillance
is dependent on having UDI in place – that includes effective use of the
Sentinel Initiative, device registries, and the ability to more precisely
identify problems and inform patients when problems with devices are
identified. Five years ago, Congress mandated the creation of UDIs when the
last user fee agreement was reauthorized — setting a timeframe for
implementing this system is critical to patient safety in the future.
Reclassification procedures
(Senate, Sec. 601) – Support Senate.
The ability to create an expedited
process to more appropriately reclassify devices is a tool the FDA needs in
this fast-paced market. Our specific interest is in the ability to
up-classify devices that have caused serious harm to patients so that similar
device applications in the future will require more scrutiny of their safety.
This provision does not allow expedited reclassification without cause – it
must be based on new information that the agency receives about the
particular device. The process outlined in the Senate version strikes the
appropriate balance between providing sufficient due process for manufacturers
and input from all stakeholders AND protecting patient safety. We remain
concerned that this also empowers FDA to down-classify devices more quickly.
While the companies will resist down-classification of devices where they
have invested resources in taking a device through premarket approval, we
have seen worrisome examples of down-classification of devices that then go
through the De Novo process. We look forward to working with Congress to make
sure that this provision works as intended to facilitate moving improperly
classified devices to an appropriate classification. The Senate
requirement for an annual report will help to monitor the use of this new
process.
Investigational device exemption –
Oppose House Sec. 701, Support Senate Sec. 606.
Retaining FDA’s full range of options in approving IDEs is
essential to public health in general as well as the health of the specific
patients involved in device clinical trials. The Senate version gives the
Secretary authority to put a hold on studies that pose unreasonable risks to
their subjects. This allows a time out for re-evaluation and then allows the
research sponsors to make adjustments or provide more information to address
concerns and resume the study. The House version would tie the hands of the FDA,
limiting FDA’s ability to reject IDE applications based on the likelihood of
approval.
The FDA has a specific
responsibility to ensure that the clinical studies done to investigate new
devices are worth the risk to the subjects involved and to ensure that the
many more people who would be exposed to a device post clearance or approval
are not put at risk. If the FDA realizes an investigation will not support
approval, patients ought not be exposed unnecessarily to risks associated
with the investigation.
Timeline for Post-market
surveillance studies (Senate, Sec. 603) – Support Senate.
We strongly support expeditious
completion of 522 studies ordered by the Secretary due to concerns about the
safety of devices, typically based on reports to the FDA about patient harm.
Until these ordered studies are completed, doctors continue
implanting them in patients and future users of the devices are endangered.
It is essential that these studies about the safety of devices be done in a
timely manner. The Senate bill requires these studies to begin not
later than 15 months after being ordered. Consumers Union specifically
advocated for timelines for these studies to be tied to the initial
Secretary’s order and urges its inclusion in the final bill.
Sentinel (Senate, Sec. 604; House,
Sec. 762) – Support Senate.
We strongly
support adding medical devices to the Sentinel Initiative and appreciate that
both the House and the Senate included devices in this important post-market
surveillance tool. The House version is comparable to the Senate except that
it strikes a section that requires the Secretary to include reporting data of
serious adverse drug experiences and events — including those submitted by
patients, health care providers, and manufacturers – in the post-market risk
identification and analysis system. This House language would eliminate
critical information from the agency’s post-market oversight of drugs (and
devices as added in both versions of the bill) and should not be removed from
current law.
Condition of Approval Studies
(Senate, Sec. 602) – Support Senate.
The Senate bill
codifies a current practice that allows the FDA to require approval for
high-risk devices to be contingent on completing specified post market
studies. This clarifies that the Secretary can impose civil monetary
penalties on companies that fail to complete these studies and will level the
playing field for companies that do comply with such requirements.
Thank you for your work on this
important legislation. If you have any questions about the above
recommendations, please don’t hesitate to contact us.
Lisa McGiffert
Director, Safe
Patient Project
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