December 27, 2022: NCHR public comments on EPA’s proposed draft supports the need for recordkeeping and reporting as they are vital steps toward managing perfluoroalkyl and polyfluoroalkyl substances (PFAS). However, there are accountability loopholes identified in this proposed draft that could allow manufacturers to take advantage of the system, ie. making it optional to register an unknown chemical with a CASRN or other identifier and not required. It is for reasons like this that we believe the draft does not go far enough.
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NCHR Comments on FDA Ethical Considerations for Clinical Investigations of Medical Products Involving Children
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 »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 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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