April 28, 2016. More clinical studies are desperately needed to determine the safety of drugs in lactating mothers. When these studies are in the planning stages, be cognizant of enrolling mothers that represent a wide diversity of races, ethnicities, and–when appropriate for the drug–ages.
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 MEDCAC Concerning Treatment Resistant Depression
April 27, 2016. Testimony at Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) regarding the definition of treatment resistant depression, the use of the definition in clinic and research, and research concerning treatment resistant depression.
Read More »Testimony at FDA on Eteplirsen for Duchenne Muscular Dystrophy
April 25, 2016. U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works.
Read More »NCHR Testimony at FDA on Hearing Aid Good Manufacturing Practices
April 21, 2016. We support the need to improve access to high quality hearing aids and other medical devices for the aging population. However, we are very concerned that there is a heavy focus on increasing the adoption of hearing aids that is not balanced by strong explicit attention to safety or to devices that work well for the individuals buying them. We recommend stronger evidence explaining and supporting the safety and effectiveness of devices that impact hearing.
Read More »Letter to House Appropriation Committee Members Regarding FDA’s Proposed Rule on the Labeling of Generic Drugs
April 18, 2016. The National Center for Health Research strongly urges you to remove the anti-consumer language from the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language (Section 747) was added at the 11th hour and it would prevent the FDA from finalizing its proposed rule on generic drugs labeling.
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