December 27, 2022: We address suggestions of how to improve this guidance to promote safety and efficacy in clinical investigations of medical products involving children. Many new medical products that are used by children are never actually tested on them or approved for them prior to entering the market. Many children are either left with no treatment options or given products “off label” that have not been tested for safety, effectiveness, or dosage requirements in patients of their age, size, or weight.
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 HHS and FDA’s Request for Information on Ortho-phthalates for Food Contact Use
December 27, 2022: NCHR strongly urges the FDA to ban the remaining phthalates from materials that have contact with food, and to rigorously enforce this ban. Phthalates are endocrine disrupting chemicals that have potential adverse effects for children and adults, such as fertility issues and obesity, and can be detrimental even at low levels of exposure. These toxins are found in many items used in food preparation, contact, and packaging, and can leach out of these products where they can be consumed or inhaled.
Read More »NCHR Comments on FDA Updates to the Breakthrough Devices Program to Reduce Disparities in Health Care
December 20, 2022: We disagree with the guidance because of the enormous loophole it represents. Altering the eligibility criteria for the breakthrough pathway to include certain devices that have the “potential” to benefit certain populations is too vague. FDA must Improve the standards of evidence required to authorize Breakthrough medical devices prior to focusing on equity issues.
Read More »NCHR Testifies Before Cardiovascular and Renal Drugs Advisory Committee on Heart Failure Drug
Dr. Ealena Callender of National Center for Health Research tells Dec. 2022 FDA Advisory Committee to require better research on OM heart failure drug due to lack of evidence of efficacy and concerns about safety due to toxicity.
Read More »NCHR Letter to Senate HELP and House Energy & Commerce Committees Regarding the VALID Act
December 14, 2022: We strongly support the inclusion of the VALID Act in the year-end omnibus spending package. This important bill will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable.
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