July 30, 2019. To ensure that requiring the availability of blister packaging does not have unintended consequences that outweigh any benefits, we encourage the FDA to study blister packaging for outpatient IR-opioid dispensing to assess how such packaging influences prescribing and usage, and thus affects the misuse or abuse of opioids.
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 Testimony at FDA’s Limited Population Pathway for Antimicrobials & Antifungals Meeting
July 12, 2019. There is broad agreement that there is a need to develop new antimicrobials to treat serious or life-threatening infections, however we have serious concerns about FDA’s draft guidance describing the Limited Population Pathway (LPAD).
Read More »NCHR Comments on USPSTF Draft Recommendations on Abdominal Aortic Aneurysm Screening
July 12, 2019. We support the USPSTF draft recommendation related to screening for AAA in asymptomatic adults 50 years and older. The differences in prevalence, risks of surgery, likelihood of benefit, and amount of available evidence support the need for different recommendations based on gender/biological sex and smoking history.
Read More »NCHR Comments on FDA’s Guidance on Post-Approval Pregnancy Safety Studies
June 28, 2019: NCHR public comment urges FDA to require safety studies of drugs taken during or after pregnancy that include women of all races, ethnicities and access to insurance. FDA should require better tracking of medication risks, and ensuring that research represents all races, ethnicities, and insurance types (including uninsured women and those on Medicaid). With 9 out of 10 pregnant women taking medications, we need better safety data to protect both mothers and babies.
Read More »NCHR Testimony on Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents
June 20, 2019. We agree with the FDA and the Panel that the increased risk for death for patients treated with paclitaxel-coated balloons or –eluting stents, as shown in the meta-analysis of randomized pivotal trials, is very concerning. Any potential increase risk for death is important for health care professionals and patients to know about, so that they can make appropriate decisions about whether to use a product.
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