June 17, 2022: In 2018 FDA was concerned about “the numbers of reports of death and other serious adverse events” regarding this drug, which already carries a black box warning that there is “increased mortality in elderly patients with dementia-related psychosis.” To outweigh such serious safety risks, the benefits of this drug would need to be substantial. However, there is no such evidence.
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.
Patient, Consumer, and Public Health Coalition Letter to Senate HELP on the Updated Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA)
June 13, 2022: While pleased with many of the changes in the updated bill introduced on May 26, we continue to have serious concerns regarding a number of provisions, including: lack of sufficient post-market surveillance of medical devices; several weaknesses regarding accelerated approval reform; lack of bill language to improve the diversity of patients in clinical trials used as the basis of FDA approval decisions; and the lack of post-market surveillance activities in the VALID Act.
Read More »NCHR Comments on Recommended Diversity Plan to Improve Enrollment of Racial and Ethnic Minorities in Clinical Trials
June 13, 2022. We strongly support FDA’s proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. For too long, clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. However, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations.
Read More »Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices
June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.
Read More »NCHR’s Testimony on Elivaldogene Autotemcel
June 9, 2022. We agree with FDA scientists in their summary that “The uncertainty regarding efficacy at 24 months following treatment is particularly problematic in the context of the recent discovery of a serious safety concern, the development of MDS, a life-threatening malignancy which occurred in 3 subjects.” We share the concerns of the FDA that two of the events are definitely related to the product and the third is highly likely to be related.
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