June 27, 2013
I am Dr. Jennifer Yttri. Thank you for the opportunity to speak today on behalf of the National Research Center for Women & Families. The Center does not take funding from device manufacturers and I have no conflicts of interest.
The Center uses research-based information to encourage new, more effective treatments, programs, and policies that promote public health. We conduct research, publish our findings in medical journals, and provide unbiased and understandable information to patients, health professionals, and policy makers through CMEs, briefings, testimony, and reports.
Our major focus is the quality of medical care and medical products, and our president is on the Board of Directors of two nonprofit organizations dedicated to helping the FDA obtain the resources it needs: the Reagan-Udall Foundation and the Alliance for a Stronger FDA.
There are a number of reasons why the hemoperfusion systems discussed today should remain Class III devices, requiring a PMA.
These devices are intended to reduce mortality from poisoning or drug overdose. This life-saving indication deserves a class III designation, and a PMA requirement to prove safety and effectiveness. That is absolutely crucial because there currently is no clear evidence providing reasonable assurance that hemoperfusion systems are safe or effective.
Based on the risk information provided by FDA, and confirmed by a device manufacturer in comment to the FDA docket, the proposed special controls will fail to provide appropriate effectiveness information. Lack of biocompatibility, unclear labeling, and poor removal of toxins all were reported in complaints to the device manufacturer and have been identified as significant risks.
Bench testing of absorption has not been proven to correlate with important patient outcomes such as survival. The only way to get this information would be through PMA process requiring clinical testing.
Some of the risks on the long list provided by FDA are similar to other devices used for the same indication. But how do hemoperfusion systems compare to other devices? There is limited scientific evidence comparing hemoperfusion to standard treatments for drug overdose or poisoning. Hemodialysis seems to be preferred, as it is better tolerated by patients and works for a larger range of toxins than hemoperfusion. There is no scientific evidence that hemoperfusion is as safe or effective as hemodialysis.
Hemoperfusion systems have not been proven to save lives or reduce morbidity. And yet that is the goal of these devices. The effectiveness in removing toxins from the body seems to vary depending on the device, treatment duration, and the target drug.
In conclusion, we don’t know how well these devices work for any type of overdose, and their safety is especially questionable when used to treat hepatic coma or metabolic disturbances. In both of these cases, hemoperfusion is being used as a potentially life-saving treatment.
The proposed special controls will NOT be adequate to ensure the safety and benefit of patients requiring hemoperfusion. Bench testing of functionality and drug adsorption does not reflect patient survival. Labeling approved for these devices by FDA has already proven ineffective at providing safety and use information to patients and medical professionals. Biocompatibility and performance data are no substitute for clinical testing.
Please vote to retain the class III classification for hemoperfusion devices for all indications, Our goal today is to make sure that these life-saving devices are safe and effective.