January 9, 2023: NCHR strongly agrees with CPSC’s proposed ruling that APBR has an “unreasonable risk of injury and death associated with entrapment hazards” and enthusiastically supports CPSC’s plan to make the voluntary safety standards mandatory, include new requirements for testing and labeling, and consider banning the products if the new standards do not substantially improve their safety. It is important to consider alternatives to APBR’s if it becomes necessary to ban them, and alternatives can be bed trapezes, adjustable beds, nonslip mattress pads, and bed exit alarms.
Read More »On Medical Treatments & Products
NCHR Testifies Before Cardiovascular and Renal Drugs Advisory Committee on Heart Failure Drug
Dr. Ealena Callender of National Center for Health Research tells Dec. 2022 FDA Advisory Committee to require better research on OM heart failure drug due to lack of evidence of efficacy and concerns about safety due to toxicity.
Read More »NCHR urges FDA to require more diversity in trials to improve accuracy of pulse ox devices
December 2, 2022: NCHR testified at an FDA meeting that there is strong evidence that commonly-used pulse oximeters are less reliable for patients with pigmented skin. The FDA’s current guidelines do not require product labeling to address the impact of skin pigmentation on pulse oximetry. While labeling is important to alert users to possible inaccuracies, it does not diminish the importance of developing devices that are effective for everyone.
Read More »National Center for Health Research Comment on Proposed Labeling Recommendations for Patients Considering LASIK
November 25, 2022: NCHR does not support nonbinding FDA LASIK guidance saying it is not enforceable and does not protect patients. We strongly urge the FDA to require patients to be provided with short, easy-to-understand labeling prior to scheduling surgery, and that the FDA improve their example of a LASIK Patient Checklist to provide more balanced information about risks.
Read More »NCHR criticism of drug for chronic kidney disease at FDA Advisory Committee Meeting
November 16, 2022: Elevated phosphorus is a serious complication encountered by the majority of patients with chronic kidney disease on dialysis. Tenapanor represents a novel approach to this major problem. Still, we are concerned about this product because the data do not show it to be more effective than current options, and the significant side effects may lead to poor patient compliance.
Read More »