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 »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
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the drug “from sale for reasons of safety or effectiveness” in March 2021 and yet, this drug has not been added to the “Withdrawn or Removed List”.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 An inclusion on the list at the same time as the product is withdrawn from the market is necessary to protect the public health.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’s Testimony to FDA on the Novavax COVID-19 Vaccine
June 7, 2022: While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine?
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.
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