June 13, 2024: The Patient, Consumer, and Public Health coalition testified at the FDA listening session on Advisory Committee reform. We expressed concerns with the miscategorization of Consumer Representatives on AdComs, the inherent conflicts of interests of committee members, and inadequate training provided to appointees.
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NCHR’s Public Comment on Early Alzheimer’s Disease: Developing Drugs for Treatment; Draft Guidance for Industry
June 10, 2024: NCHR disagrees with assumptions made in FDA guidance aimed at developing drugs for treatment of early stages of Alzheimer’s dementia.
Read More »NCHR Comment on Proposed Information Collection Request; Comment Request; POTW Influent PFAS Study Data Collection
May 28, 2024: NCHR supports the EPA’s proposed plan to collect data on PFAS contaminants in public water sources but urges EPA to protect public health by expanding the plan to test for many more PFAS chemicals and at more testing plants.
Read More »NCHR Testifies at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting on Shield Guardant Health
May 23, 2024: NCHR provided public testimony at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting regarding the safety and effectiveness of Shield Guardant blood test for colorectal cancer screening. We advised more research was needed prior to approving the test due to the low sensitivity in detecting colorectal cancer at the earliest stages.
Read More »NCHR Testifies at the Pediatric Oncology Subcommittee Meeting
May 22, 2024: NCHR provided public testimony at the pediatric oncology subcommittee meeting regarding Section 504 of the 2017 FDA Reauthorization Act. We expressed concern that efforts to increase availability of new treatments for pediatric cancer have resulted in more planned studies but not in more treatments. We recommended sponsors prioritize engaging with key stakeholders such as the EMA Paediatric Committee, FDA Pediatric Review Committee, FDA Oncology Subcommittee of the Pediatric Review Committee, the Oncology Center of Excellence, and the use of independent Pediatric Expert Groups.
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