May 17, 2017. We strongly urge this Advisory Committee to prioritize patient safety and urge the FDA to establish high standards for preclinical and clinical studies. Like any public health strategy, a vaccine’s risks must be weighed against its benefits. Given all the mistrust of vaccines in a substantial minority of Americans, it is especially important to determine how effective the vaccine is at preventing RSV and for how long. If the vaccine does not protect infants and young children through a vulnerable period of development or contributes to negative side effects, then the risks of this vaccine are too high. Given that there have been significant issues with past RSV vaccines, the FDA should ensure that they do not recommend this vaccine prematurely, especially for such a vulnerable population.
Read More »On Medical Treatments & Products
NCHR Comments to FDA Advisory Committee on Organ Care System-Lung
May 17, 2017. There is tremendous pressure to have more treatment options, but if the FDA approves OCS despite the lack of unbiased evidence of non-inferiority, many lives will be put at risk. Improving the studies – including following the clear advice of the FDA – will answer all the essential questions about whether OCS is non-inferior to cold storage, and for whom.
Read More »NCHR Comment on the USPSTF’s Draft Recommendations for Breast Cancer: Medications for Risk Reduction
April 19, 2017. We support the USPSTF’s efforts to re-evaluate recommendations as the scientific evidence expands and improves. In addition, we strongly urge the USPSTF to consider how the apparently modest benefits of medications compare to specific lifestyle changes for reducing breast cancer risk.
Read More »NCHR Comment on the USPSTF’s Draft Recommendations for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing
April 12, 2017. We support the USPSTF’s efforts to provide updated recommendations on risk assessment, genetic counseling, and genetic testing on BRCA-related cancer, based on quality, up-to-date scientific studies. We hope the review will quantify the benefits and harms of each step starting with screening, in order to help USPSTF to make meaningful recommendations for appropriate subpopulations of women.
Read More »NCHR Testimony at FDA on Opioid, Opana ER
March 14, 2017. Compared with other opioids, reformulated Opana ER, along with its generic counterpart, had the highest injection abuse rates following reformulation.
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