September 26, 2016. NCHR president Dr. Diana Zuckerman explains that the NCHR believes the bill is needed because “it provides an important incentive for manufacturers to do a better job of testing the safety of their implants and other devices. The incentive would be their desire to avoid law suits by patients harmed by defective high-risk medical devices.”
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 says YES to the Medical Device Guardians Act
September 26, 2016. NCHR supports this bill because there is clear scientific evidence that the vast majority of adverse events from medical products are not reported by physicians, and the percentage may be especially low for devices. “Since most devices are allowed to be without any scientific evidence of safety,” Zuckerman points out, “requiring adverse events to be reported by physicians is especially important.”
Read More »FDA Guidance Would Lower Safety Standards for High-Risk Medical Devices
September 14, 2016. NCHR strongly opposes this draft guidance. It does not enhance FDA’s goal of “protecting and promoting the public health.”
Read More »NCHR Supports FDA’s Guidance on Generic Drug Labeling Safety
September 9, 2016. NCHR supports this draft guidance, which is a step in the right direction for protecting the public health. However, the guidance should be broadened to include all situations, regardless of whether the RLD has been withdrawn. Moreover, to truly ensure that generic drug labels are updated in a timely manner, the FDA needs to finalize the proposed rule, “Supplemental Applications Proposing Labeling Changes For Approved Drugs and Biological Products.
Read More »NCHR Testimony at the FDA’s Public Hearing on Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products
September 13, 2016. NCHR strongly supports the FDA’s regulation of cell and tissue products. The guidances are reasonable. Through regulation the FDA can protect patients and encourage innovation in the development of new treatments based on sound science. However, enforcement will be critical to stop untested and potentially harmful ‘therapies’.
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