May 26, 2023: FDA draft guidance contained numerous recommendations that would improve the quality of research submitted in support of accelerated approval for oncology drugs. However, we recommended the FDA explicitly specify that studies need to have a majority of patients enrolled prior to receiving accelerated approval and that they advise against the use of single-armed trials.
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.
Under pressure from patients, FDA faces tough choices on experimental gene therapy
Boston Globe, May 22, 2023: Boston Globe quotes NCHR and other experts explaining why we are concerned that Sarepta’s gene therapy for Duchenne Muscular Dystrophy isn’t proven to work and has substantial risks. If it doesn’t work, patients who use it will not be able to try other, potentially better gene therapies in the future.
Read More »NCHR Comments on AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management
May 19, 2023: NCHR commented on the AHRQ Systematic Review of Peripheral Nerve Blocks (PNB) for Postoperative Pain Management. Helping patients avoid opioids in the postoperative period may prevent pain conversion from acute to chronic pain, and also avoid opioid addiction. In order to achieve these two goals, opioid-sparing pain medications must be safe and effective in the postoperative period. Peripheral nerve blocks (PNB) have the potential to reduce perioperative opioid use and its associated adverse effects.
Read More »NCHR Comments on the FDA Draft Guidance Evaluating the Safety of Antimicrobial New Animal Drugs
May 19, 2023: NCHR supports the proposed criteria for ranking antimicrobial new animal drugs according to their importance to human medicine; however these criteria need to be applied correctly. FDA should classify bacitracin as medically important and should almost always give antibiotics belonging to the same drug class the same rankings of medical importance.
Read More »NCHR Comments on the FDA Filing of Color Additive Petition Concerning Red No. 3
May 18, 2023: NCHR strongly supports the petition from the Center for Science and the Public Interest urging an FDA ban on the use of FD&C Red No. 3 in foods, drugs, and dietary supplements. We find it unacceptable that the FDA has known for more than 30 years that Red 3 can cause cancer and yet still allows the dye to be used in these products.
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