NCHR Comments on Manufacturer Communications on Use of Off-Label Medical Products

January 6, 2017. Based on research showing the clear risks and relatively modest benefits to patients, and the even greater costs to public health when there is inadequate evidence to make informed decisions, we strongly oppose allowing companies to promote medical products for off-label uses. These views are based on evidence and have been confirmed by speaking with hundreds of patients harmed by medical products that they did not know were being used off label.

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NCHR Comment on EPA’s New Chemical Review Program

January 17, 2017. As a think tank focused on public health, we strongly agree that chemicals should be carefully evaluated before they are sold, as well as afterwards. People who work around new chemicals should be informed of the risks and the appropriate protections. Thorough evaluations of new chemicals by the EPA can reduce the risks of many new chemicals, saving lives and improving the health of people who live and work in the United States.

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Women’s Low Sexual Interest: NCHR Comment on FDA Guidance

December 23, 2016. There is a need to find treatments for low sexual interest, desire, and/or arousal in women, as those conditions affect women’s quality of life. However, the scientific standards should be solid, and consistent with long-term use, if that is the intent. If a sponsor does not want to conduct a large enough study to carefully evaluate safety and efficacy for all the known subgroups, the FDA should approve the drug only for those subpopulations that have been found to have benefits that outweigh the risks.

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NCHR Testimony at 2016 FDA Workshop on Role of Hospitals in Modernizing Evidence Generation for Device Evaluation

December 5, 2016. Hospitals are expected to play a key role in evidence generation and adverse event reporting for the National Evaluation System for Health Technology. While the collection and analysis of real-world data will be important for post-market surveillance of medical devices, the quality of information being collected and used for decision-making must be focused on making patient safety a priority.

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