July 15, 2022: We agree that there is evidence that PET Aß imaging is a useful tool to support a diagnosis of Alzheimer’s Disease as part of a clinical trial protocol. However, there are conflicting data regarding its usefulness to determine the effectiveness of Alzheimer’s Disease treatment strategies.
Read More »On Health Policy
Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation
July 12, 2022: We write to urge you to expeditiously consolidate the two pieces of legislation to reauthorize the Food and Drug Administration (FDA) user fee programs for medical products. We request your consideration on reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests.
Read More »NCHR Comments on Fostering Medical Device Improvement
July 5, 2022: This proposed draft guidance on Fostering Medical Device Improvement aligns closely with the needs of medical device companies, but not with the needs of patients and consumers. NCHR has many concerns about the proposed program.
Read More »NCHR’s Public Comment on Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting
June 21, 2022: While we agree that these potential modifications are a great step forward in ensuring that unused medications are properly disposed of, overprescribing continues to be a major problem in the U.S. There should be continued efforts to educate physicians and pharmacists on reducing the number of opioids prescribed and providing alternatives to opioid analgesic prescriptions…
Read More »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.
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