November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.
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 on the FDA’s Post-Marketing Pediatric-Focused Product Safety Reviews
September 28 2018. In its public comment, NCHR calls for better monitoring of children’s drug side effects, stronger warning labels, and parent-friendly information about risks of ADHD drugs and medical devices. The FDA’s current reporting system misses many adverse reactions due to under-reporting, and psychiatric risks from ADHD medications need more prominent warnings.
Read More »NCHR Testimony at the FDA’s Pediatric Advisory Committee Meeting
September 20 2018. At an FDA Advisory Committee meeting, NCHR challenges FDA’s safety conclusions about psychiatric drugs for children, arguing Lexapro lacks evidence for kids under 12 and Intuniv causes serious side effects. Despite NCHR’s concerns, the Pediatric Advisory Committee voted 11-1 to continue current monitoring rather than requiring stronger warnings or additional research.
Read More »NCHR Testimony on Prucalopride for Chronic Idiopathic Constipation
October 18 2018: At an FDA Advisory Committee, the National Center for Health Research testified about our concerns regarding prucalopride’s safety and effectiveness for U.S. patients with chronic idiopathic constipation. They emphasize the need for more patient diversity in the clinical trials and longer-term studies to ensure the drug’s suitability for the broader American population.
Read More »NCHR Testimony on the Opioid Sufentanil
NCHR testifies against the approval of Sufentanil, a new sublingual opioid 10-15 times more potent than fentanyl.
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