December 15, 2014. We strongly oppose the down-classification of External Pacemaker Pulse Generator (EPPG) devices and Pacing System Analyzers (PSAs) from Class III to Class II. The Cardiovascular Devices Panel stated on March 9, 1979 that these devices should be classified into Class III because the device “provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.”
Read More »On Medical Treatments & Products
NCHR Testimony at FDA Advisory Committee on Anti-Infective Drugs
December 5, 2014. We are all concerned about the growing problem of antibiotic resistance. We want to ensure effective treatment options for those with serious infections. However, ineffective antibiotics actually worsen our situation by increasing antibiotic resistance.
Read More »NCHR Testimony at FDA Blood Products Advisory Committee
December 3, 2014. The FDA’s regulation of blood establishment computer software (BECS) and BECS accessories has enhanced the safety of blood transfusion. However, it should be noted that the only national statistics we have to measure safety are based on a passive reporting system.
Read More »NCHR Position on the Safety of Essure Permanent Birth Control
November 6, 2014. The NBC investigation of Essure has raised very important questions regarding the safety of the Essure permanent birth control device.
Read More »NCHR Testimony at FDA Joint Public Advisory Committee Meeting on Chantix
October 16, 2014. NCHR strongly urges the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, the FDA should delete the misleading meta-analyses info from the Chantix label.
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