June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.
Read More »On Health Policy
NCHR’s Testimony on Elivaldogene Autotemcel
June 9, 2022. We agree with FDA scientists in their summary that “The uncertainty regarding efficacy at 24 months following treatment is particularly problematic in the context of the recent discovery of a serious safety concern, the development of MDS, a life-threatening malignancy which occurred in 3 subjects.” We share the concerns of the FDA that two of the events are definitely related to the product and the third is highly likely to be related.
Read More »NCHR’s Testimony to FDA on Lorcaserin Hydrochloride (BELVIQ)
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the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”.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 An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.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 »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.
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