April 22, 2016. The House Appropriations bill for FDA includes riders that will harm your constituents by reducing the safety and effectiveness of drugs and devices. These provisions include dangerous sections of the House’s 21st Century Cures Act that the Senate HELP Committee rejected.
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NCHR Testimony at 2016 FDA Advisory Committee Meeting on Opioid REMS
May 4, 2016. If we want to reduce deaths and addiction due to opioids in the United States, we must demand more from everyone involved. Prescribers must be better informed, REMS assessments must be more rigorous, and the data must be transparent.
Read More »Testimony at FDA on Eteplirsen for Duchenne Muscular Dystrophy
April 25, 2016. U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works.
Read More »NCHR Testimony at FDA on Hearing Aid Good Manufacturing Practices
April 21, 2016. We support the need to improve access to high quality hearing aids and other medical devices for the aging population. However, we are very concerned that there is a heavy focus on increasing the adoption of hearing aids that is not balanced by strong explicit attention to safety or to devices that work well for the individuals buying them. We recommend stronger evidence explaining and supporting the safety and effectiveness of devices that impact hearing.
Read More »Letter to House Members Opposing Language Added to the Appropriations Bill that Lowers the FDA’s Safety and Efficacy Standards for Drugs and Devices
April 15, 2016. The National Center for Health Research strongly opposes language added at the last minute to the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language lowers the FDA’s safety and efficacy standards for approving drugs and medical devices and will put the public health at risk. These are the same provisions that members of the Patient, Consumer, and Public Health Coalition have previously opposed. We urge you to oppose including in the appropriations bill language that lowers FDA’s standards for drugs and devices.
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