On Medical Treatments & Products Archives

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.

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.

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.

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.

NCHR Comments On Emergency Authorization for New COVID-19 Drug

November 9, 2022: FDA Advisory committee considers EUA emergency authorization of new COVID-19 treatment. NCHR says study is small and flawed and additional data are needed and FDA advisors agree.