June 8, 2022. FDA announced that the risks of BELVIQ outweigh any potential benefits and withdrew the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”. Delaying the inclusion of unsafe drug products poses an entirely avoidable risk for patients. An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.
Read More »On Health Policy
NCHR Comments on Regulating Menthol in Tobacco Products
June 6, 2022. We strongly support the proposed tobacco product standards that would prohibit menthol in cigarettes and prohibit characterizing flavors in all cigars. While the proposed product standards are an important first step, we also urge FDA to prohibit menthol in all e-cigarettes and related products, in addition to enforcing efforts to prohibit fruit, dessert, and some other flavored cartridge-based sales. Through such efforts, there is a significant opportunity to reduce nicotine addiction in the United States, particularly among young people who increasingly suffer from that addiction as they grow older.
Read More »Patient, Consumer, and Public Health Coalition Letter on FDASLA Act of 2022
May 22, 2022: We appreciate the opportunity to submit comments and feedback on the draft legislation, the Food and Drug Administration Safety and Landmark Advancement Act of 2022, which will reauthorize the Food and Drug Administration (FDA) user fee programs.
Read More »NCHR Comments on Quality System Regulation Amendments for Medical Devices
May 24, 2022. We recognize that the proposed harmonization with international consensus standard for devices would allow companies to have a single quality management system. However, the proposal ignores several issues of great importance to patients and consumers, and these issues deserve more attention as FDA considers changes to the proposed rule.
Read More »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.
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