Thursday, June 7, 2012
Patient Safety Provisions From Senate’s Version Of FDA User Fee Act
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 7, 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, healthcare 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.
Director, Safe Patient Project
Senior Policy Analyst
Contact: Michael McCauley, email@example.com, 415-902-9537 (cell)