user fees Archives

Patient, Consumer, and Public Health Coalition Letter to Senate HELP and Energy and Commerce Committee Regarding User Fee Reauthorization Legislation

September 22, 2022: 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.

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.

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.

Patient, Consumer, and Public Health Coalition Letter on FDA Amendments Act H.R. 7667

May 17, 2022: 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. There are numerous important provisions in the FDA Act, but in this letter we will focus on two major issues: accelerated approval and contrast imaging agents.