The Wall Street Journal, January 29, 2020. New FDA Commissioner Stephen Hahn faces tug of war over controversial issues in health, including e-cigarettes, stem-cell research, and the use of cannabidiol (CBD).
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NCHR Comments on FDA’s Notice on the Modified Risk Tobacco Product Application for Copenhagen Snuff Fine Cut
January 21, 2020. We strongly oppose the approval of the modified risk application for Copenhagen Snuff Fine Cut with the claim “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.” This claim may encourage non-smokers to begin using tobacco. Using smokeless tobacco increases the risk of serious health issues.
Read More »NCHR Testimony on Aximris as an Abuse-Deterrent Opioid for Long-Term Treatment
January 15, 2020. FDA should require sufficient evidence that this drug’s abuse-deterrent properties will result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes.
Read More »NCHR Testimony on Tramadol and Celecoxib for Acute Pain Relief
January 15, 2020. There is absolutely no evidence that this combination drug with an opioid is as effective or more effective than a standard dose of just the NSAID.
Read More »NCHR Testimony on SABER-Bupivacaine for Post-Surgery Pain Relief
January 16, 2020. There is not good evidence that SABER-bupivacaine provides a meaningful benefit to patients, and certainly not proven that the benefits outweigh the possible risks. Most important, the sponsor has not proven that this formulation of the drug works better or is safer than the opioid, bupivacaine. Bupivacaine itself has been on the market for decades, is available as a generic, and does not have these new safety concerns. Thus, there is no reason to approve this drug just to have “another tool” when there is no evidence that it is a better tool than currently available options.
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