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the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”.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 An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.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 »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.
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