February 15, 2018. It remains unclear whether individual achievement of abstinence is sustainable over time and whether long-term NRT use is more or less beneficial on an individual or population health level. We commend the FDA for addressing their role in developing strategies to evaluate NRT products and labeling. We agree that urgent action is necessary and the FDA should consider science-based approaches to reduce further harm from combustible tobacco products.
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 Comments on Changes to Medical Software Policies Due to 21st Century Cures Act
February 15, 2018. The draft guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act removes FDA evaluation of EHRs and leaves only certification by the Office of the National Coordinator for Health Information Technology (ONC) to ensure that software is both functional for providers and safe for patients. However, ONC certification is not sufficient to protect patients from problems with EHR software. For that reason, the draft guidance as written puts patients’ lives at risk.
Read More »NCHR Testimony On Long Acting Nerve Blocking Agent, Exparel
FDA, February 15, 2018. We need post-surgical pain treatments that spare patients from opioid use. However, at this time, the data are insufficient to recommend supplemental approval of Exparel.
Read More »NCHR Testimony at FDA About New Opioid Combination, Hydexor
February 14, 2018. Consider how this drug fits into the context of the drug market and how it is likely to be used or misused. Do the benefits outweigh the risks of putting another conventional opioid on the market, one that is designed to treat its own side effects, and are the attempts to reduce excess pills sufficient? Opioids provide both a benefit and a harm in our society. As Advisory Board members, please advise the FDA to carefully and cautiously consider the potential for abuse of this opioid.
Read More »NCHR Comments to USPSTF on Non-traditional Screening Methods for Heart Disease
February 12, 2018, USPSTF. We agree with the USPSTF that current evidence is insufficient to assess potential benefits and harms of adding the ankle-brachial index (ABI), high-sensitivity C-reactive protein (hsCRP), or coronary artery calcification (CAC) score to the traditional risk assessments for CVD.
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