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.
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Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants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.
Read More »NCHR Testimony on Tazemetostat for Epithelioid Sarcoma
December 18, 2019. We can all agree that there is a need for better treatment options for patients with epithelioid sarcoma. We can also agree that new treatments still need to have a real and meaningful benefit to patients. Just as important, there needs to be enough information about this treatment option so that patients and their physicians can determine if the benefits outweigh the risks for each patient, so they can decide whether or not to try it. There can be differences of opinion on what would be a meaningful benefit and what is a likely risk, and those will vary for individual patients.
Read More »NCHR Testimony on Olaparib for the Treatment of Germline BRCA-Mutated Pancreatic Cancer
December 17, 2019. The limitations of this study make the evaluation of the risks and benefits associated with Olaparib for germline BRCA-mutated pancreatic cancer difficult.
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