May 9, 2017. While FDA is appropriately and routinely hearing from patients desperate for new treatments, those are not the only patients who have important perspectives from which the agency can learn.
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.
Here are our Statements and Positions on issues that affect you.
Letter Opposing Amendments to FDA’s User Fee Program that Weaken Patient Safeguards
June 5, 2017. When an unproven assertion of safety and effectiveness is relied on to market a medical product, the resulting harm may be severe—even life-threatening.
Read More »NCHR Testimony to FDA in Preparation for the 2017 International Cooperation on Cosmetics Regulation (ICCR) Meeting
May 25, 2017. In summary, endocrine disrupting chemicals and other harmful substances are present in many cosmetics in the United States. These substances can harm the health of adults and children, and it is essential for the FDA and the ICCR to consider the growing evidence for their harm. We urge the FDA and ICCR to establish high standards for maximum levels of endocrine disruptors and require manufacturers to clearly label their presence in products.
Read More »NCHR Testimony to FDA About L-Glutamine for Sickle Cell Crisis
May 24, 2017. Sickle cell disease and the crises that it causes are a serious problem. Patients deserve and need new treatments. This requires high-quality clinical studies to demonstrate whether new treatments are effective and safe. When many of the patients that start a study drop out before it is completed, it is impossible to accurately evaluate the benefits compared to the risks. … FDA should approve new treatments based on clearly demonstrated evidence of efficacy and safety. This requires high-quality clinical trials where post patients stay in the trial. FDA should not approve a drug with questionable benefit when the dropout rate is concerning.
Read More »NCHR Testimony to FDA About Neratinib to Prevent Breast Cancer Reccurance
May 24, 2017. The FDA should be sure that new treatments provide a real benefit to patients before they are approved. We recommend that the FDA not approve neratinib for breast cancer unless a clear benefit can be replicated, or a benefit for overall survival is demonstrated.
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