December 4, 2023: NCHR expressed concerns that accelerated approval for stimulant addiction treatment will jeopardize patient safety and drug effectiveness. We also recommended the study design include a diverse patient population to best reflect the intended patient population, and improving study end-points to be more reflective of real-world practice.
Read More »Author: Caroline Bradford
NCHR Comments on FDA’s Proposed Rule “Medication Guides: Patient Medication Information”
November 29, 2023: In response to FDA’s draft guidance on patient medication information guides, NCHR recommends that the FDA includes information on important drug interactions and develops a strategy to ensure the materials meet the average health literacy of the population.
Read More »Patient, Consumer, and Public Health Coalition Letter to FDA Regarding Consumer Representatives in Advisory Committees
November 20, 2023: The Coalition expressed concerns that patients, health professionals, and industry-affiliated individuals are erroneously categorized as Consumer Representatives on FDA Advisory Committees.
Read More »NCHR Comments on Health and Human Services’ Proposed Healthy People 2030 Objectives
November, 2023, NCHR supports HHS’ proposed healthy people 2030 objectives and the inclusion of social determinants of health as key measurable objectives. To strengthen HHS’ goal of improving community health and achieving health equity, we recommended including individual and organizational health literacy objectives and forming inclusive, diverse stakeholder committees.
Read More »NCHR Provides Oral Testimony at the FDA Pulmonary Allergy Advisory Committee Meeting on Gefapixant
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.
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