April 19, 2023: FDA has worked with industry to propose a clinical trial to determine safety and efficacy of extended release (ERLA) opioids for chronic pain. We criticized the proposed study due to bias, poor study design, and ethical considerations for patients who could be harmed by the study. We urge the FDA to revise the labels to restrict the use of these opioids for chronic pain, based on current data and not wait for what could be an inevitably flawed study to be completed.
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 CMS Inflation Reduction Act Initial Program Guidance
April 14, 2023: NCHR comment on the CMS plan to fully implement the authorities provided by Congress in the Inflation Reduction Act (Pub. L. 117-169) to lower the costs of prescription drugs for beneficiaries through drug price negotiations.
Read More »NCHR Comments on CPSC Proposed Rulemaking on Safety Standards for Non-full-size (NFS) Baby cribs.
April 5, 2023: NCHR supports the additional standards to improve the safety of non-full-size cribs by regulating cords and straps that form a loop and the addition of language to prevent exemptions for cribs intended for playing. However, we also recommend revision to the proposal exempting certain products from including a mattress.
Read More »FDA Accelerated Approval Pathway: Controversies and Reform
Recent controversies of drugs granted accelerated approval have raised important questions about the evidence needed to determine whether the benefits outweigh the risks in the short-term or the long-term, and what can be done to improve the pathway.
Read More »NCHR addresses proposed changes to acne medicine iPLEDGE program
March 29, 2023: NCHR testimony at an FDA advisory committee recommends changes to the iPLEDGE REMS (risk reduction) program for patients taking the acne medication isotretinoin, which causes birth defects. We recommend eliminating unnecessary barriers for women who are unable to become pregnant and strengthening contraceptive requirements for adolescents.
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