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.

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Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices

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.

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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. 

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drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”.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 An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.

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