November 17, 2023: NCHR provided testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on a new treatment for refractory or unexplained cough, Gefapixant. We reviewed the research which showed Gefapixant had a modest difference in cough frequency (<1%) and improved quality of life (1 point reduction) when compared to placebo, a small reduction that is of little value to patients. One third of patients also reported an adverse taste-related event with Gefapixant. We concluded that Gefapixant does not adequately address the unmet need for treating patients with refractory or unexplained cough in terms of effectiveness or tolerability.
Read More »On Medical Treatments & Products
NCHR testimony at the FDA Oncologic Drugs Advisory Committee meeting regarding the dangling accelerated approvals of pralatrexate and belinostat for peripheral T-cell lymphoma
November 16, 2023: We believe it necessary for FDA to rescind approval until a trial is completed that confirms meaningful clinical benefits
Read More »Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators
November 7, 2023: Blood irradiator devices have been used for decades on cancer patients to try to prevent metastasis. NCHR agrees with FDA there is no evidence that they benefit patients and it is clear the radiation can be harmful. At an FDA Advisory Committee meeting in November 2023, we urged FDA to finally require scientific studies if companies want to continue to sell these devices.
Read More »NCHR’s Comments on Proposed Supplemental Guidance for CPSC Chronic Hazard Guidelines
NCHR criticizes CPSC’s revised proposal for chronic hazard guidelines for focusing on linear modeling that is not appropriate for endocrine disrupting chemical and for including a loophole that enables companies to do whatever they think is scientifically appropriate. We urge the CPSC to produce more explicit, rigorous guidelines based on sound science, since that is essential for the safety of consumers.
Read More »NCHR Comments on FDA’s Draft Guidance on QTc Information in Human Prescription Drug and Biological Product Labeling
October 10, 2023, in response to FDA’s draft guidance on QTc product labeling to
correctly measure heartbeat contraction and relaxation, NCHR recommends that FDA specify a preferred method of calculating the QTc, provide methods for to improve
study design, and require studies of the impact of drug-drug and
drug-disease interactions. These changes to the guidance are needed to encourage industry to do the research needed to ensure the safety and effectiveness of their products.