Comments on Proposed Order Regarding Sorbent Hemoperfusion Devices

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, Maryland 20852

May 6, 2013

Comments of Members of the Patient, Consumer, and Public Health Coalition
on Proposed Order
Regarding Sorbent Hemoperfusion Devices
[Docket No. FDA-2013-N-0195]

 

As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for sorbent hemoperfusion devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.[1]  We strongly oppose down- classifying the devices for the treatment of poisoning and drug overdose.

Sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances.

This device has a long list of health risks including platelet loss, blood loss, hypotension, toxic reactions, metabolic disturbances, and electrical shock. Additionally, there is no proof that the device provides clinical improvement in hepatic coma and metabolic disturbances.1  We strongly support FDA’s Class III PMA recommendation, so that these products could not be sold unless new data are provided that prove their safety and efficacy for this indication.

Sorbent hemoperfusion devices for the treatment of poisoning and drug overdose.

Regarding the reclassification of sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, members of the Patient, Consumer, and Public Health Coalition strongly oppose the reclassification (from Class III to Class II) as we noted in our May 17, 2012 comments to Docket No. FDA-2012-M-0076.  Given FDA’s statement that “the device may lead to the failure to remove drugs in the treatment of poisoning or drug overdose,”1 as one of the reasons for supporting its PMA recommendation, it is inappropriate to down-classify it for any indication.

A significant problem with this proposed order is that it splits the device into two classifications (Class III and Class II).  A down classification from Class III to Class II (and 510(k) clearance) would not require a sponsor to prove that their product is safe or effective.  Even if the device were cleared by the 510(k) process for one particular indication, it could easily be used off-label for treatments that require a PMA, such as treating hepatic coma and metabolic disturbances.   In other words, down-classification for any indication would create an enormous and dangerous loophole that would allow manufacturers to avoid the more rigorous PMA review process.

Members of  the Patient, Consumer, and Public Health Coalition strongly support the FDA recommendation to require the PMA review process for sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances.  This device has substantial health risks and lacks “valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness.” We strongly oppose down- classifying the devices for the treatment of poisoning and drug overdose.

 

Center for Medical Consumers
Connecticut Center for Patient Safety
Consumers Union
National Research Center for Women & Families
National Women’s Health Network
The TMJ Association
U.S. PIRG
WoodyMatters

 
For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org

 


[1] Federal Register (April 4, 2013).  Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose. [Docket No. FDA-2013-N-0195]