It is essential that all data collected by any of the registries are made publicly available for research purposes, and all results are available to the public. We strongly urged CMS to make this a requirement as a condition of coverage.
On the State and Federal level, legislation is passed every year that affects our access to healthcare as well as the quality and affordability of our health care. We fight for legislation that will improve the health of all adults and children across the country.
The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.
We support this CT quality measure because it establishes a floor and a ceiling to provide an optimal level of radiation exposure for imaging for numerous different conditions, without reducing the diagnostic benefits of those scans.
The Patient, Consumer, and Public Health Coalition, scheduled a hybrid meeting with FDA Commissioner Califf and other key FDA officials to discuss accelerated approval, reform to diagnostic lab developed test regulation, and improvements to FDA Advisory Committees.
February 27, 2023: The Coalition urges Congress to support the decision by the Centers for
Medicare and Medicaid Services (CMS) to limit the coverage of newly approved Alzheimer’s
drugs until the treatments have been shown to have a meaningful, clinical benefit that outweighs
the risks for the Medicare population.
We applaud your National Coverage Determination limited coverage of this class of drugs solely to patients participating in clinical trials following the approval of aducanamab (Aduhelm) by the FDA. The FDA approved Biogen and Eisai’s lecanemab today, and we urge you to hold firm to your decision to prioritize patient safety and the scientific credibility of CMS’s coverage decisions.
We are writing to express our strong support for your bipartisan support for the VALID Act earlier this year, and to urge you to include it in the Omnibus Spending bill with a few small improvements. Our concern is that women and men who are at high risk of breast cancer or other types of cancer are not currently able to have confidence that genetic tests used for screening and diagnosis.
It is critically important that House and Senate committees work together to consolidate differences between the Food and Drug Amendments Act (H.R. 7667), which passed the House of Representatives on June 8, and the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348), which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 15.
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.
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.