Members of the Patient, Consumer, and Public Health Coalition strongly support FDA’s ban on the imports of Ranbaxy medical products

September 26, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s ban on importing drugs manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The company’s facility is not complying with current good manufacturing practices (cGMP), which are the main regulatory safeguard to ensure drug manufacturing quality. Continue reading

Comments on “Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses”

September 17, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class III with Premarket Approval applications (PMA) required. Continue reading

Testimony of Dr. Caitlin Kennedy, Senior Fellow, at FDA Advisory Committee on reclassification of External Pacemaker Pulse Generator Devices

September 11, 2013. We strongly oppose the reclassification of External Pacemaker Pulse Generator Devices from class III (high risk devices) to class II (moderate risk devices). We urge you to recommend that these devices should remain class III and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices and because clinical data are urgently needed to provide useful information to health professionals about the benefits and risks. Continue reading

Comments on Proposed Order “Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs”

September 10, 2013. As members of nonprofit patient, consumer, and public health organizations, we oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a Class III device, indicating high risk) into Class II (moderate risk). This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.
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Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All”

September 9, 2013. Comments of the Patient, Consumer and Public Health Coalition to FDA on “Ensuring Access to Adequate Information on Medical Products for All.” We are writing to express our strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations. Continue reading

Office of the Commissioner Joint Meeting of the Gastroenterology-Urology Devices Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee on Computed Tomography Colonography

September 9, 2013. We agree with the Task Force that at this point, there is no reason to recommend virtual colonoscopies for most patients who need screening. We would add, however, that if specific patients are unwilling to undergo regular colonoscopies, then a virtual colonoscopy is a reasonable alternative. Continue reading

Letter to the CA Bureau of Electronic and Appliance Repair, Home Furnishings and Thermal Insulation, in Support of the Proposed Modified Flammability Standards for Upholstered Furniture

As a nonprofit organization dedicated to improving public health, the National Research Center for Women & Families strongly supports the proposed revisions of California’s flammability standards for upholstered furniture and other products. Continue reading

Comments on Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina and Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses

August 19, 2013. We are writing as members of the Patient, Consumer, and Public Health Coalition to express our concerns about the proposed down-classification from Class III to Class II of External Counter-Pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization.  We strongly support the proposed PMA for other indications for the same ECP devices. Continue reading