My name is Tess Robertson-Neel, and I am speaking today on behalf of members of the Patient, Consumer, & Public Health Coalition, which is an informal coalition of more than 2 dozen nonprofit organizations that focuses on ensuring safe, effective, and affordable medical and consumer products. The Patient, Consumer, and Public Health Coalition does not accept funding from entities with financial ties to our work.
Our nonprofit member organizations are key stakeholders that have been actively engaged in previous MDUFA reauthorizations, and appreciate being able to share our perspective here today.
We support the reauthorization of MDUFA, but we strongly urge that MDUFA performance goals need to be more patient-centered and focused on quality rather than only on speed of reviews. We know that getting new devices on the market more quickly can be beneficial to patients, but not when there is no evidence that the devices are at least as safe and effective as other products on the market. Our coalition includes nonprofit organizations that have worked closely with patients who were harmed by medical devices that were later recalled due to harmful complications. Other patients have used devices that clearly did not work. Our coalition also includes healthcare professionals that know how difficult it is to make informed medical decisions when data are lacking and safety signals from adverse events or published studies are not evaluated in a timely manner.
For that reason, many of our member organizations have concluded that MDUFA V has not provided the kinds of benefits to patients, consumers, or public health that U.S. taxpayers deserve. CDRH needs to treat U.S. taxpayers as their valued customers, which is how it has been treating industry.
To do that, MDUFA VI should have performance goals that indicate additional staff and resources will be allocated to ensure the safety and effectiveness of devices on the market, not just the speed in getting them to the market. Post-market surveillance is especially important given the lack of clinical trials for more than 95% of new devices on the market every year. MDUFA funds need to help pay for staff who focus on those important safeguards.
Additionally, MAUDE needs to be improved so that it is easier for the FDA and independent researchers to evaluate adverse events. That should include FDA enforcing the use of unique identification numbers (UDIs) as intended. For example, Device Events tells us that there are more than 165,000 adverse event reports for synthetic surgical mesh in the FDA public database – not including mesh for pelvic organ prolapse, which is no longer on the market. User fee funds need to be used to evaluate adverse event reports so that patients know if certain products or certain uses are especially likely to be harmful.
In addition, MDUFA funds should be used to help FDA make sure that all individual adverse event reports are publicly available, instead of providing exemptions that allow some companies to hide tens of thousands of specific reports in a summary that does not provide information that has implications for safety or effectiveness.
Unfortunately, 510k user fees are much too low to support both careful premarket review and post-market surveillance. User fees need to be increased to reflect the FDA’s purported focus on being more patient-centered and transparent and less cozy with industry.
To make our voices heard, patient, consumer, physician, and public health stakeholders need to be able to actively participate in MDUFA meetings where FDA and the device industry negotiate. At the very least, we should have access to remotely watch those negotiations, rather than depend on minutes that are often so vague or delayed that stakeholders have no opportunity for meaningful input. We’ve been told that the FDA represents the needs of all stakeholders in MDUFA negotiations, but our emphasis on safe and effective devices has not been reflected in the MDUFA V Commitment letter.