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.
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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.
Read More »National Center for Health Research Statement on Oxycodegol Before the FDA Advisory Committees
January 14, 2020. This FDA hearing was about the risks and benefits of a new opioid, oxycodegol, for the management of chronic lower back pain. We pointed out that experts now agree that patients with chronic pain should not be started on opioids, which are less effective than other options.
Read More »Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants
December 23, 2019. We are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person is considering surgery.
Read More »NCHR’s Comments on FDA’s Proposed Rule on Tobacco Product Applications
December 16, 2019. FDA’s proposed requirements for premarket tobacco product applications (PMTAs) defines the extent to which FDA is able to thoroughly evaluate the potential health effects of these products on consumers and, in particular, vulnerable populations such as children and adolescents.
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