May 19, 2023: NCHR commented on the AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management. Helping patients avoid opioids in the postoperative period may prevent pain conversion from acute to chronic pain, and also avoid opioid addiction. In order to achieve these two goals, opioid-sparing pain medications must be safe and effective in the postoperative period. Peripheral nerve blocks (PNB) have the potential to reduce perioperative opioid use and its associated adverse effects.
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NCHR Comments on the FDA Draft Guidance Evaluating the Safety of Antimicrobial New Animal Drugs
May, 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 »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.
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