May 19, 2023: NCHR supports the proposed criteria for ranking antimicrobial new animal drugs according to their importance to human medicine; however these criteria need to be applied correctly. FDA should classify bacitracin as medically important and should almost always give antibiotics belonging to the same drug class the same rankings of medical importance.
Read More »On Medical Treatments & Products
NCHR Comments on the FDA Filing of Color Additive Petition Concerning Red No. 3
May 18, 2023: NCHR strongly supports the petition from the Center for Science and the Public Interest urging an FDA ban on the use of FD&C Red No. 3 in foods, drugs, and dietary supplements. We find it unacceptable that the FDA has known for more than 30 years that Red 3 can cause cancer and yet still allows the dye to be used in these products.
Read More »Testimony of Diana Zuckerman on the Treatment of Duchenne Muscular Dystrophy before the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee
We testified at the May 2023 FDA Advisory Committee that Sarepta’s new treatment for Duchenne Muscular Dystrophy isn’t proven to work or to be safe, and that the company’s 3 previously approved DMD treatments are still not proven to work and have not submitted confirmatory trials as required.
Read More »NCHR Testimony at the FDA Advisory Committee Hearing on OTC Access to Norgestrel (OPill)
May 9, 2023: NCHR testified on the proposed first-in-class prescription-to-nonprescription switch of OPill (norgestrel) tablet, a progestin-only oral contraceptive pill (POP), and expressed concerns that the data demonstrated that a substantial minority of consumers did not understand written information about how to use the pill safely if they were not instructed by their physician.
Read More »Public Comment of Dr. Diana Zuckerman, President National Center for Health Research At the FDA Advisory Committee meeting on Rexulti for Alzheimer’s patients April 14, 2023
April 14, 2023: Rexulti is already FDA approved as an atypical antipsychotic and FDA held an Advisory Committee meeting in April 2023 to consider approving it for agitation in dementia patients, many of whom are in nursing homes. We expressed concerns about Rexulti’s well-known risks of death for dementia patients. Why isn’t FDA more concerned about safety?
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