October 10, 2017. Recalls demonstrate the crucial need for improved medical device quality, and for more clinical testing of such devices before they are put onto the marketplace, as well as improved inspections of manufacturing facilities prior to them going on the market. It’s a positive sign that this pilot program will address at least some of these inspectional issues.
Read More »On Health Policy
NCHR Statement on Right To Try Legislation before the House Energy and Commerce Subcommittee on Health
October 3, 2017. We strongly urge this Committee to reject the Right To Try legislation that is currently under consideration, because it would undermine the successful FDA compassionate waiver program already in place to enable patients to have access to experimental drugs for free or at cost.
Read More »NCHR Testimony at the FDA Panel on Ataluren
September 28, 2017. We agree with FDA scientists that the data today do not indicate significant benefit in randomized, double-blind, placebo-controlled trials, such as Study 7. Only after making many post-hoc changes did ataluren show it was effective for ADP patients, but this was not replicated in Study 20. As you know, those post-hoc manipulations do not provide clear evidence of efficacy. For both studies, 90% and 79% of patients were White. But the CDC reports that Hispanic males are disproportionately likely to have these conditions. It is essential that an adequate number of Hispanic males be analyzed to determine if they can benefit from a treatment such as ataluren.
Read More »NCHR Comments to CPSC on the Organohalogen Flame Retardant Petition
September 14, 2017. In order to keep our children safe, it is essential to regulate OFRs collectively as a class unless and until there is scientific evidence that one or more particular OFRs is proven to be safe, and then treat that specific OFR differently.
Read More »NCHR Testimony at the FDA Advisory Committee Meeting on Codeine in Children’s Prescription Cough Medication
September 11, 2017. There are serious risks and no clear benefits for cough medicine with codeine for children of any age. And while we can’t say for certain whether giving opioids to children has long-term negative effects contributing to opioid abuse by teenagers, that logically makes sense. Why not prevent opioid use in children when we can?
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