Janet Phoenix MD MPH, Amanda Bisnath, Megan Peterson, Elizabeth Sack Since the discovery of the first antibiotic, penicillin, in 1928, antibiotics and antimicrobial drugs have been widely used in the United States. Over time, some bacteria have developed ways to survive these drugs. Unfortunately, the widespread use of antibiotics has contributed to the development of […]
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NCHR Comments on FDA’s OMHHE Strategic Priorities
February 28, 2020. Efforts to improve inclusion of racial and ethnic minority populations in clinical trials need to include incentives that are more effective than merely asking companies to do so. Greater diversity would, in turn, improve the generalizability of clinical trial results and provide patients and health care professionals with the information necessary to make an informed decision about which products to use for which patients.
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.
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Read More »NCHR Comments on FDA’s Draft Guidance on Post-Market Studies and Clinical Trials
December 20, 2019. Post-market clinical trials and other studies can help inform FDA and the public about the risks and benefits of medical products. However, when they are relied upon to answer questions better addressed prior to approval, or if less effective studies or trials are used, or if studies are delayed and inadequate, they do not provide the intended data that is needed by FDA, patients, and healthcare providers. This adds to the already high cost of medical care.
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