Health Legislation

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.​

Coalition letter to CMS on Lecanemab approval and maintaining their coverage decision

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.

Joint Letter from from Cancer Groups and Patient-Centered Nonprofits about VALID Act in Omnibus

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.

Coalition Letter To Senate HELP And Energy And Commerce Committee On User Fee Reauthorization Legislation

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.

Coalition Letter to Senate HELP and Energy and Commerce Committee on User fee reauthorization legislation

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.

Coalition letter to Senate HELP on the Updated FDASLA draft

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.

Coalition Letter to Senate HELP on FDASLA Act of 2022

The Honorable Patty Murray Chair, Committee on Health, Education, Labor and Pensions United States Senate 428 Dirksen Senate Office Building Washington, DC 20510 The Honorable Richard Burr Ranking Member, Committee on Health, Education, Labor and Pensions United States Senate 428 Hart Senate Office Building Washington, DC 20510 Dear Chair Murray and Ranking Member Burr,  As …

Coalition Letter to Senate HELP on FDASLA Act of 2022 Read More »

Coalition Letter to Energy and commerce Committee on FDA Amendments act H.R. 7667

Representative_____ Energy and Commerce U.S. House of Representatives Washington, DC Dear Representative______, As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong support for several provisions in The Food and Drug Amendments Act (H.R. 7667), and our concerns about other provisions that could be improved. The coalition was founded …

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Public Comments on FDA’s Medical Devices Commitment letter

We would like to express our substantial concerns with the overall process as well as the shortcomings of the Commitment letter. The negotiations between the Food and Drug Administration (FDA) and medical device industry were not transparent and excluded patients, consumers, and other stakeholders.