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 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 …

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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.

Coalition Letter to FDA and CDRH regarding MDUFA Reauthorization

As key stakeholders, we strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review, in order to achieve the FDA’s mission to protect patients from unsafe products and enhance public health.

Public Comments on FDA’s Generic Drugs Commitment Letter

We believe that the proposed recommendations must do more to ensure that generic drugs are providing an equally beneficial treatment for patients and consumers. We appreciate the efforts of the agency to work toward those ends, but as long as patients and consumers are excluded from the GDUFA negotiations, the concerns and priorities of these principal stakeholders will also be excluded.