Comments on Reclassifying External Pacemaker Pulse Generator Devices and Pacing System Analyzers

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.” Continue reading

Statement of Anna E. Mazzucco, Ph.D. Before the Food and Drug Administration on Updating the “Redbook”

December 9, 2014. We enthusiastically welcome further action from the FDA on all substances over which the Center for Food Safety and Applied Nutrition has authority. While the FDA has taken steps to address safety concerns regarding some substances, we strongly urge the agency to use its full authority to ensure the safety of all food-related and consumer products. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan Before the FDA Advisory Committee on Anti-Infective Drugs

December 4, 2014. Antibiotic resistance and the inability to treat common infections is an increasingly urgent public health crisis which affects everyone, especially some of the most vulnerable in our society. Finding treatment options for unmet populations is urgently important but ineffective antibiotics lead to an increase in antibiotic resistance. Continue reading

Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

October 29, 2014. We welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care. Continue reading

Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix

October 16, 2014. We strongly urge you to urge 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, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label. Continue reading