May 31, 2016. The National Center for Health Research (NCHR) opposes the proposed rule for Blood Establishment Computer Software (BECS) and Accessories, which would classify these devices as class II (special controls). Since there have been injuries and even a death associated with these devices, we strongly recommend they be reviewed through the more rigorous PMA (class III) approval process. PMA applications would provide physicians, researchers, and patients detailed information about the studies and tests submitted to approve the devices—information which is lacking on BECS devices that are currently cleared by the 510(k) process.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
NCHR Comments to FDA on Draft Guidance for Generic Abuse-Deterrent Opioids
May 24, 2016. NCHR agrees with many of the recommendations in the guidance and strongly urge the FDA to consider our recommendations regarding the use of the term “abuse-deterrent,” the development of guidance addressing additional abuse-deterrent technologies, the scrutiny applied to Tier 1 studies, and the enforcement of post-marketing study requirements for reference products.
Read More »NCHR Testimony at 2016 FDA GDUFA Regulatory Science Meeting
May 20, 2016. Generic drug research and policies have an enormous impact on the health and safety of millions of Americans and impact patient and prescriber confidence in generic drugs. We urge you to consider research that will improve drug quality through rigorous manufacturer inspections, increase patient safety through the communication of important drug information on generic drug labels, and promote the uptake of generic drugs where they have the potential to reduce cost and improve outcomes.
Read More »NCHR Email to Senate Staff: Don’t Gut the FDA
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.
Read More »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.
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