October 26, 2017. The HHS has drafted a strategic plan for implementation over the next several years. We object to language that is non-scientific and themes which weight political rhetoric and ideology over sound scientific principles. Read more of our comments here.
Read More »On Health Policy
NCHR Letter to the DC City Council on Artificial Turf
October 26, 2017. It is clear that city officials have assumed artificial turf products are safe because the salespeople told them they were safe. Unfortunately, there is clear scientific evidence that these materials are potentially harmful, and the only question is how harmful are they and how much exposure is likely to be harmful? Our children deserve better.
Read More »NCHR Comments at CDRH’s Voluntary Medical Device Manufacturing and Product Quality Workshop
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 »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.
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