October 10, 2023, in response to FDA’s draft guidance on QTc product labeling to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.
On Medical Treatments & Products
NCHR Comment on CPSC’s Proposed Study of Toddlers Using Smart Toys
October 6, 2023: The Consumer Product Safety Commission is responsible for ensuring that consumer products are safe. One of their jobs is to make sure toys are labeled to indicate the age of children for which they are safe and age-appropriate. In October 2023, NCHR reviewed a proposed CPSC study of new toys intended for ages 2-4 and expressed concerns that there were too few children in the proposed study to provide reliable, generalizable information about the use and safety of these toys for a diverse group of U.S. children.
Read More »Dr. Diana Zuckerman’s Testimony at the FDA Advisory Committee on NurOwn for ALS Treatment
September 27, 2023: NCHR’s Diana Zuckerman’s testified at FDA’s Advisory Committee meeting on September 27, 2023 about tripling of deaths and no benefits of NurOwn treatment for ALS. Improvements were identical for placebo compared to NurOwn treatment, and patients should not have to pay for unproven treatment. Experimental treatment should be free through clinical trials or expanded access.
Read More »NCHR Testimony at the Meeting of the Nonprescription Drugs Advisory Committee Concerning Oral Phenylephrine (PE) as a Nasal Decongestant
September 11, 2023: Orally administered phenylephrine (or PE) as a nasal decongestant should not be on the market because it has not been shown to work. Millions of dollars have been wasted by consumers on a product that has been shown in research to act similar to a placebo.
Read More »NCHR Comments on Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
September 11, 2023, NCHR supports the FDA’s draft guidance with key recommendations. NCHR urges the FDA to add standardized protocols for instances of participant non-adherence, disease flair up, and acute illness. NCHR also recommends including specific guidance for crossover clinical trial design and more objective measures for dietary compliance rather than food diaries to strengthen the quality of the clinical trials performed among the IEM patient population, reduce confounding, and improve data interpretability.
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